10 Leading Diagnostic Solution Providers 2019 by insightscare

Vol. 5 / Issue-1

www.insightscare.com May 2019

10 Leading Diagnostic Solution Providers 2019

Robert HuďŹ&#x20AC;stodt President & CEO

Empowering Providers through Point-of-care Testing

Editor-in-Chief Pooja M. Bansal Senior Editor Anish Miller Managing Editor Ashwini S. Deshpande Executive Editor Aishwarya Naw andhar Contributing Editors Sayali Rane, Sneha Sinha Visualiser David King Art & Design Head Amol Kamble Art & Design Assistant Poonam Mahaj an Co-designer Paul Belin

Art & Picture Editor Rahul Kavanekar Business Development Manager Peter Collins Marketing Manager Marry D'Souza Business Development Executive M a r k Williams Sales Executives Amy, John, Bill,

Sarah Technical Head Jacob Smile Assistant Technical Head Pratiksha Patil Technical Consultants David, Robert Digital Marketing Manager Alina Sege Assistant Digital Marketing Manager Prashant Chevale

S M E - S M Osales@insightscare.com Executives Manoj, Gemson, Um a

May, 2019

OfSmith ces: ResearchCorporate Analyst Eric

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Editor’s Column

iagnosis is a very crucial part of the treatment of any health related disorder. Without proper diagnosis, reaching the real problem is very difficult and guesswork based treatment methodology in the medical field can sometimes be very dangerous. The field of diagnostics is advancing and many new techniques have come up that are taking us towards precision medicine and patient personalized solutions. The technique that has grabbed a lot of attention in the last few years is molecular diagnostics. In simple terms, it means the analyzing of a patient is done at molecular level. Molecular diagnostics involve examination of the biological markers in a person’s genome (genetic code), testing of DNA/RNA sequences for identification of the disease, cellular testing, etc.

Future of Medical Diagnosis Going Molecular!

It allows the detection of pathogens in a human body as well as genetic testing. In pathogen detection, molecular diagnosis searched for signs of pathogen-derived nucleic acids in the patients and hence, helps identify the infection. In genetic testing, mutation of the cells, genetic disorders, chronic diseases, etc. can be diagnosed. Molecular diagnostics can truly revolutionize care by helping us move towards accuracy and personalized medicine. Molecular diagnostics field has seen rapid and large growth in the past few years and it is predicted that it will continue to do so further. This owes to the advantages it brings, which include accurate, analytically sensitive, and fast detection as well as monitoring of a number of diseases. Today, there are various tools and technologies available for this and it doesn’t stop here, there is so much more to explore. Molecular diagnostics has not just enabled disease characterization, but it goes a step ahead and has enabled patient characterization. Used particularly in the fields of oncology, infectious diseases, and congenital abnormalities, clinical pathology at the molecular level is improving patient monitoring and management. In 2017, the global market for molecular diagnostics was reported to be valued at $7.5 billion and this is expected to go up to $15.6 billion by 2024. With new infection and chronic diseases coming up every day, it has emerged to a very important revolution in healthcare. Molecular diagnostics has the potential to aid early detection and diagnosis of diseases as deadly as cancer and d the a Naofwanahar ary Editor further advancements in this field comes with Aishawpromise better tomorrow!

The Industry Leaders Transforming the Diagnostic Space

he first step to treating any health condition is diagnosis. If not diagnosed rightly, a patient may not receive the needed effective treatment on time and this can lead to major complications in the future. The significance of correct diagnosis is taught to every medical student from the very start. Today, healthcare is moving towards personalized medicines and correct detection of the ailment is the key to reach there. Although it is very important to focus on this segment of the care industry, only two to three percent of the total healthcare resources are spent on diagnosis, according to a qualified report. There are few prominent companies that are remarkably transforming the diagnostics industry with their innovative tools, technologies, and techniques and taking us closer to personalized healthcare. In our special issue of “10 Leading Diagnostic Solution Providers 2019”, we have featured top diagnostic companies that have not only enabled correct detection of diseases but have aided in early diagnosis and are contributing largely to the better tomorrow of healthcare. Featured on the cover of this issue is PTS Diagnostics. It is revolutionizing the diagnostic industry by innovating point-of-care with people, technology, and service. Other than the insightful cover story, we have also featured the top industry leaders dedicated to provide enhanced diagnostic care to all. These include BioDirection, a medical device company that develops state-of-the-art point-of-care products to manage traumatic brain injuries and concussions; Biolumo that is focused on developing a set of tools for fast and inexpensive antibiotic resistance detection; Colorimetrix, which develops testing applications that turn smartphones into portable labs, enabling the semi- quantitative measurement of diagnostic tests at home; Genomic Expression, a leading organization that sequences RNA to identify the best drug for the patient and the best patient for the drug; MedCloud, a patient-centered platform for diagnosis, focused on simplifying test management in all its phases; Exagen Diagnostics; GeneNews; IR2Dx; and NHG Diagnostics. Apart from this, the issue also incorporates an ingenious article from Tania Martin-Mercado, the Chief Technology Officer of YGEIA, as well as a few interesting articles from our in-house editors. So, walk through the pages and enjoy a good read!

C 0 NTE O8 N Cover Story

PTS Diagnostics Empowering Providers through Point-of-care Testing

Adroit Outlook What Digital Startups Need to Succeed in the Healthcare Space?

T S

ARTICLES

Industry Trends

2 2

Recent Advancements in Diagnostic Industry

1 6 2 6

3 6

Editorâ&#x20AC;&#x2122;s Angle Never Miss a Dose: Medication Apps

4 0

BioDirection Unlocking the Power of Nanotechnology to Address TBI

2 0

Biolumo Delivering a Fast Point-of-care Antibiotics Selection Tool

Colorimetrix Bringing Lab Diagnostic Tools to the Hands of Everyone

3 2

Genomic Expression Improving Care and Saving Lives

Medcloud Centralizing Data for Decentralizing Care

COVER STORY

Robert Huffstodt President & CEO

PT Diagnostic S s Empowering Providers through Point-of-care Testing

One of the key challenges for healthcare solutions providers, is to develop products and programs that help address the growing demand for chronic disease management in a way that increases eﬃciency, lowers costs, and increases patient satisfaction. PTS Diagnostics, a provider of state-of-theart point-of-care testing solutions is rising to the challenge. Through the company’s commitment to customer focus, innovative technology, and adherence to robust quality standards, they have established themselves as a leader in the manufacture of fast, accurate, and portable point-of-care testing devices. And, they have recently begun building more on that strong foundation with PreVantageTM, a suite of products,

strategies, and partnerships aimed at helping healthcare providers thrive in a rapidly changing industry.

“The industry is in

a period of transition, domestically and both worldwide. We are transforming along with the industry

Humble Roots Headquartered in Indianapolis, Indiana, with major operation centers in Sunnyvale, California, PTS Diagnostics was founded in 1992 by an individual who had been aﬀected by diabetes. As a patient, he saw how small, portable glucose meters could quickly and conveniently measure blood glucose levels. He soon realized that there was an unmet market need for a similar device that could that could measure a number of additional chronic disease risk indicators, such as blood cholesterol and ketone levels.

In its early days, PTS Diagnostics was a one-man shop, run out of the founder’s home. Within a couple of years, enough angel funding was raised to move to a business building and hire additional people. In 1997, the company moved to its current location, where more oﬃce and lab space was gradually added over the next 25 years as the company grew. In 2013, PTS Diagnostics acquired A1CNow® from Bayer. In 2016, it was acquired by its current parent company, Sinocare.

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he healthcare industry is in a period of transition both domestically and globally. This is driven by a host of factors from legislation and regulation to the growth of populations with chronic health conditions such as diabetes. The search for adaptive solutions is intense, and the pressure on companies and organizations to innovate and bring new, high-quality solutions to market quickly is strong.

holding on to its identity and its reputation for quality service. It fought against all odds to find its place in the market, and managed to get where it is now through perseverance and angel investments. “I’m immensely proud of this,” asserts CEO Robert Huffstodt. Passionate Leadership PTS Diagnostics is led by President and CEO Robert Huffstodt, he is a Notre Dame graduate with a background in finance. He considers himself very lucky to have had the opportunity to lead a number of organizations early in his career. Being assigned the task of conducting financial audits for startups and smaller companies helped him gain a thorough understanding of what made these organizations tick.

The company has now expanded to such an extent that it has outgrown its current location, and will move into a brand new, 145,000 square-foot facility in the Spring of 2019.

“When I moved out of public accounting and into the private world, I again found myself at a startup. It was here where a mentor gave me the opportunity to dip my toe into every discipline, from sales calls to factory management,” he says. This gave him a ﬂavor of what it was like to run a whole business from top to bottom and has directly contributed to his success with PTS Diagnostics.

Over the years, the company placed a great deal of focus on growth and proﬁtability, while

Huﬀstodt has also always had an aﬃnity for international business. This has served him well as the receptivity

On the personal side, Huffstodt has a passion for music, art, and architecture. These interests have inspired him to create an environment within the company’s new global headquarters that is conducive to creativity and innovation. People, Technology, and Service The company’s name represents the three pillars upon which it has built its long-term success: People, Technology, and Service. ‘People’ starts in-house with the skills, talents, and energy of PTS Diagnostics’ global employees and partners. It extends to its strongly-held value of providing high-quality service, person to person. That’s why the company intends to always have real humans answering its calls. “It sends the signal that we’re approachable and are about people,” says Huffstodt. ‘Technology’ points to the company’s innovative products and solutions. PTS Diagnostics integrates old technology and new technology to develop products that are accurate, reliable, and easy to use. Huffstodt says, “We’re not trying to release new updates just because we can. Pairing well-tested elements with modern updates that we believe in allows us to have the best of both worlds.” Since PTS Diagnostics has been focused on perfecting its craft instead of always rushing to the newest thing, many of its technologies and products have stood the test of time. ‘Service’ also has a dual meaning. Internally, the company prizes excellent service provided among departments and employees, but it takes particular pride in the level it service it strives to provide to the customer, which ranges from training

to logistics and other elements of its business. As the company moves beyond its products, and toward more comprehensive services and solutions with PreVantage, service will take on yet another level of significance. Flagship Products PTS Diagnostics’ signature products include the CardioChek® analyzer and the A1CNow® test system . Both products stand out in the market by being incredibly portable, efficient, and accurate. They also recently launched PreVantage which aims to enhance those products with added convenience, connectivity, and extended service features. With PreVantage, CardioChek and A1CNow are not mere devices—they are part of a solutions package that links to Electronic Medical Record (EMR) systems, which are the backbone of many of todays’ healthcare organizations. The bundled PreVantage product and connectivity offerings are intended to help healthcare organizations transition from Fee for Service payment models to Value-Based Payment models.

technology and innovation to blood collection. And, PTSConnect ProLink and PTSConnect ScreenPro simplify point-of-care health data collection and transfer for health and wellness companies, retail clinics, and urgent care centers. What Sets PTS Diagnostics Apart The creative business approaches and the collaborative spirit behind PTS Diagnostics are what allows it to work with partners all over the world and continue to grow year after year. The company is also unusual in that it has succeeded largely on its own, without venture capital or a large benefactor. It has bootstrapped itself on angel money, survived, and thrived. The history and background of the company has placed it in a unique position to serve new healthcare delivery and payment systems. PTS Diagnostics envisions becoming a

Other products The company also offers the PTS DetectTM cotinine system, PTS CollectTM capillary tubes, and PTS ConnectTM solutions. PTS Detect cotinine is the first and only The growth ofwill ourcome quantitative organization tobacco-detection from organic growth in our system that can measure exact markets, expansion of cotinine levels product offerings, broader from a simple fingerstick. PTS menus, and more Collect capillary tubes brought new new

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to PTS Diagnostics’ products in dozens of markets around the world has continued to grow.

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We striveto be innovative in our business modelsand practices, well as our products, and to as create a situation where everybody wins, from the employees and internal stakeholders to our business partners, to end users, patients, and societyat large

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We wantgrowth to achieve “proﬁtable while

global leader in providing innovative, point-of-care products and services that aid healthcare providers in their preventative healthcare and chronic disease management efforts. Other factors that set PTS Diagnostics apart from its competitors are its size, its promptness, and its resourcefulness. As a company, PTS is the right size to provide customers with flexibility and personalized service. “We’re not so big as to be rigid, ponderous, and slow to react, on the other hand, we’re not so small as to have too limited of resources” Huffstodt says. “Service and going the extra mile make us stand out.” An Insight into ‘Product Training’ PTS has a multitude of tools that enhance its training process for both professional and home users “We have a range of options available and we don’t pigeonhole customers into methods that are unconducive to their learning style or schedule,” says Huffstodt. He continues, “For us as a company, the realization of how important that was a watershed moment.” Notable Awards & Accreditations In addition to its numerous product accreditations, PTS Diagnostics has earned recognition for its unique product offerings and continued success. In addition to being listed as one of Inc. Magazine’s 5,000 Fastest Growing Companies six times, the company has also been featured on the Today Show, Doctor Oz, and other similar programs abroad.

“

maintainingour focus on consistent providing products and services that beneﬁt the constituents

Disrupting the Point-of-Care Solution Industry One of the biggest disruptions to the healthcare industry in recent years has been the shift in reimbursement models in the United States, specifically the moving away from fee- for-service models toward value-based models that pay based on the efficiency and effectiveness of care. PTS Diagnostics has recognized that outcomes are the new income™ and has the right products mix of product offerings and industry partners to help healthcare organizations make a positive impact on value-based payment objectives. The portability and ease-of-use of PTS Diagnostics’ products also position them well to help retail pharmacies, urgent care centers, and community health centers offer lipid panel and A1C wellness testing in a way that often more convenient for patients. Future of PTS Diagnostics The company is currently in a period of multiple simultaneous transitions. The first is the building of a new headquarters which will be completed in the second quarter of 2019. The launch of PreVantage solutions is also underway and is continuing to grow and evolve as a product offering and business model. And, new technological innovations are also in the pipeline. “We certainly believe that we’ll see double digit growth for the foreseeable future,” asserts Huffstodt.

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Relentless innovation for improving the diagnosis and management of TBI is what drives us. We are dedicated to improving treatment plans and saving more and more lives

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-Sharad Joshi President & CEO

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2019 /

BioDirectio n Unlocking the Power of Nanotechnology to Address TBI

raumatic Brain Injuries (TBI) and sports related concussions have become very common and are increasing at an alarming rate. There is an enormous unmet global market to need take care of up to $10 Billion Traumatic Brain Injuries (TBI). CDC estimates the direct or indirect cost spent on treatment of these concussions to be greater than $76 Billion in the US alone. Over 75 percent of TBI are classified as mild traumatic brain injuries while 90 percent of the people with concussions never lose consciousness. There is a lack of an objective point-of-injury (POI) or point-of-care (POC) test. TBI testing today is symptomatic diagnosis, which has a high error rate and is not at all definitive. This is where BioDirection, Inc. steps in and has the potential to manage the diagnosis in a specific and timely fashion. BioDirection is a privately held medical device company developing cutting-edge and rapid point-of-care or point-of-injury products for the objective diagnosis and management of concussion and other traumatic brain injury (TBI). It is leveraging the power of nanotechnology to address the rapid and definitive diagnosis of TBI. BioDirection Tbit™ System The company’s first product Tbit™ System is a whole blood POC or POI test platform for traumatic brain injury. It is rapid and affordable test that generates a result in less than two minutes from a single drop of blood. The system measures targeted brain biomarkers released from the brain following a head trauma or jolt to the body. The platform is easy-to-use, portable and low-cost system (affordable), it consists of two components: tabletop or handheld analyzer and a single-use, disposable sensor cartridge. The disposable sensor drives significant revenue – razor blade annuity. Tbit™ System has the potential to generate a high margin business with strong cash flow. BioDirection has exclusive, global rights to a Harvard generated patent portfolio for acquired brain injury and Sepsis plus extensive nano-wire based biosensor design or manufacturing know-how. The system is based on design of nanowire biosensor produced from nanowires. A single nanowire is 1/10,000 of a human hair. Tbit™ System offers ultra-sensitivity and specificity.

/ MAY 2019 /

pre-revenue start-ups, mid-market companies to large scale companies, such as Proctor & Gamble. He also has the expertise in creative product development, marketing, and technical sales instrumentation and capital equipment. Serving Global & Diverse Market BioDirection estimates up to a 5-Billion-dollar market in USA alone for its products with potential to treat greater 50 Million people around the globe. TBI injury impacts all walks of life and age groups with high potential targets extending well beyond sports (all levels – youth, interscholastic, university/college, and professional). Additional targeted markets include military training and deployment, hazardous work environments, senior living or nursing facilities, medical clinics and physician offices, first responders and ambulances, rural medicine, educational facilities, recreation and disaster relief. It uses the selected GFAP and S100b as initial targeted biomarkers; these are clinically validated over 50-60 years as acute biomarkers for TBI. S100b is approved as a screen to CT in over 20 countries world-wide outside of USA. Tbit™ System is a flexible and versatile platform and is not biomarker dependent and readily adaptable to new biomarkers. It has full multiplexing functionality, capable of measuring 2, 3, 5, 10 or more biomarkers simultaneously. It is a game changing technology and the company is targeting market entry late Q1 2020. The Outstanding Leadership Sharad Joshi, the President and CEO at BioDirection is a dynamic leader who fosters a mission-centric, fun, and collaborative environment. He holds B.Sc (Mechanical Engineering) degree with a Pre-Med minor from Northeastern University and graduated cum laude with an MBA from Babson College in Wellesley, MA. He has over three decades of experience in the medical device field including management positions as CEO, President, & COO, Marketing, International Sales, Engineering, among other executive positions. He has also been the inventor and author of numerous patents and publications. Sharad has also served as a business advisor or technical consultant at various companies including

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BioDirection’s first targeted market is a screen to a CT scan, which it estimates is up to 5 million CT scans for head injury per year in the USA. The company is awaiting its final trial results, which the company believes will approach 100 percent sensitivity to positive CT scans (100% NPV) and ability to detect abnormal protein levels consistent with micro-bleeding not found in negative CT scans. It has already received FDA Breakthrough Device Designation in January 2019. Subject to FDA review and clearance, BioDirection’s first target is to launch Q1 in 2020; this is subject to FDA review and clearance process. Future Road Map & Development Strategies Moving beyond the screen to CT, BioDirection plans to modify the existing TBI™ System providing the full continuum of care for TBI patients including stratification of injury, prognosis, and post-operative return to activity or play. Additionally, the company is also seeking a partner to develop rapid testing products for sepsis, which also require rapid diagnosis in critical conditions.

Wojciech Giżowski VP & COO

Olga Grudniak

Jakub Wysocki

CEO

CMO

Biolumo

Delivering a Fast Point-ofcare Antibiotics Selection Tool

ntibiotic resistance is a major problem faced by the healthcare industry today. It has cost a lot of monetary resources as well as a lot of companies have invested their time in ﬁnding a solution to this. Biolumo, an innovative and growing company based in Gdynia, Poland, was also set on the same quest. It faced a question from its mentor and business advisor, “Can you point any solution that will make me sure my son got the right antibiotics prescribed?” This question lighted a spark in the company’s team; a spark that started the ﬁre called Biolumo. Today, the company is focused on developing a set of tools for fast and inexpensive antibiotic resistance detection.

success alone, believes Biolumo. It believes in working as a team and with partners. The roles in the company reﬂect the responsibilities and skillset, not hierarchy. Biolumo has an amazing team starting with its Chief Science Oﬃcer, Marcin Pitek, who came with the idea. Olga Grudniak is the CEO, who combines science and business together. She is very recognized, young businesswoman. Wojciech Giżowski, the COO, is an expert on building both relations and products. He is responsible for the most partnerships and mentors that keep the company going. Jakub Wysocki keeps Biolumo on the lips of both media and investors. All of them have played important roles in the company’s success.

Founded in 2017, Biolumo has its major operation centers in Pomerania Science and Technology Park, Gdynia. It oﬀers a diagnostic eﬀectiveness on antibiogram level, delivering results 8 times faster.

The Journey of Biolumo Post Biolumo’s inception, the ﬁrst months were devoted to testing its initial idea to identify antibiotics resistance in the patients’ samples. Since then, Biolumo has evolved this method and designed fully automated prototype that can be used by every nurse.

The Fuel to its Success No one person can achieve true science and business

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It has participated in one of the best acceleration program in the world – Startupbootcamp Digital Health, which helped Biolumo in planning its international growth strategy. In Poland, the company’s country of origin, it has managed to partner up with the biggest healthcare companies on the market. “Our mission, even before the Biolumo conception, was to fight antibiotics resistance the best we can,” says Olga. The want to give scientists time to develop a sustainable successor for traditional antibiotics was the goal of Biolumo’s science team, this also included boosting effectiveness of diagnostics amongst the group that prescribes the most antibiotics, General Practitioners. Unique Point-of-care Solution Biolumo’s flagship product is a fast, point-of-care antibiotics selection device for general practitioners and clinics. The company is offering diagnostic effectiveness on antibiogram level, by delivering results eight times faster. Furthermore, its solution is automated and therefore, easy to use. It can also provide a new revenue stream for clinics. This product is a brilliant combination of biotechnology, hardware, and software. The company has used modern technology instead of XX century method, which allowed it to identify antibiotics resistance much faster. With Biolumo’s ingenious product, a laboratory, trained specialists, or the transporting sample are not needed to reach the results and that minimizes the costs further.

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We aim to improve care for all, by finding an answer to the antibiotic resistance problem, with an interdisciplinary

“

approach

The company’s interdisciplinary approach and its focus on finding the best combination of these disciplines is the key factor leading it towards success. Honorary Laurels For its remarkable contribution, Biolumo has been recognized by many national and international organizations highly regarded amongst the healthcare society. One of the biggest distinctions Biolumo has been honoured with was being listed at prestigious Global Digital Health 100 ranking by The Journal of mHealth. It has also been awarded the title - The Healthcare Leader during The XXIII International Open Healthcare Congress by the healthcare key opinion leaders in its region, in January 2018. Biolumo won the 2nd place at infoShare 2018 Startup Contest, the competition that takes place during the biggest startup conference in the CEE region. Furthermore, at the beginning of 2019, its CEO, Olga Grudniak, has been named The Best Entrepreneur in 25 Under 25 by Forbes and The Businesswoman of the Year in Poland. What’s Ahead? Biolumo is working hard to roll out its device, as soon as possible. “We want to give scientists the time to develop a sustainable successor for traditional antibiotics – our science team included – by boosting effectiveness of diagnostics,” says Wojciech. After that, it has developed plans for the next features and upgrades in its product. Speaking about the future endeavors, businesswise, Wojciech asserts, “We are working on strategies for international lunch of our device. To get the effects we hopeto achieve, we need to provide our solution worldwide, not only in our region.” Simultaneously, the company is continually working on the next generation antibiotic that should be a long-term solution for the problem, which may take some time and resources as developing any new drug does.

/ MAY 2019 /

Recent

Advancements in

DIAGNOSTIC

INDUSTRY 22 / MAY

2019 /

Industry Trends

he healthcare sector is moving from reactive care to preventive care. care helps the patient take necessary precautions to avoid certain conditions Preventive also helps them in identifying the root of a disease before it becomes and Additionally, the cost of preventive care is much less than that of reactive care. serious. Diagnostics is a major part of preventive care. All the conventional treatment methods mostly follow the trial and error method, where the illness is guessed based on the symptoms the patient shows. It is necessary to move ahead from this method to personalized care to improve the outcomes of healthcare. Optimum diagnosis is the ﬁrst step towards this. The diagnostics industry is witnessing immense transformation and there are various new developments that are helping it move towards personalized care. Let's look at the recent devices transforming diagnostics.

Better Detection of Ebola Virus with a Microﬂuid Device

Ebola is a highly contagious and deadly virus and once infected, it leaves limited treatment options for the patient. Moreover, it can spread easily and start an epidemic. To combat the dangers it brings to the human lives, scientists at the Rochester Institute of Technology (RIT) have developed the prototype of a novel micro device. This device helps diagnose the infection caused by Ebola early, which results in better treatment outcomes as well as reduces the spread of infections. The developed microfluid device has biosensors attached to it. It is a small, automated chip that has fluorescence sensors attached to it. The device detects the Ebola RNA when the patient's sample is added to it by activating the CRISPR mechanism. The researchers are further trying to find a way to generate this device at affordable costs.

KidneyIntelXA Breakthrough Device

Q-POC â&#x20AC;&#x201C; A Revolutionary Diagnostics Kit

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KidneyIntelX is the main diagnostic test for kidney diseases devised by Renalytix AI plc. It exhibits promise to improve the clinical management of patients with fast-growing kidney diseases and type-2 diabetes. It helps in better diagnosis and well as treatment of these. KidneyIntelX uses machine learning algorithms to examine the combination of predictive blood- based biomarkers. These include sTNFR1, sTNFR2, and KIM1 along with the electronic health record data. The device is designed to identify the progressive kidney disease. It was designated as a Breakthrough Device by FDA.

A Remarkable DNA Sequencing Device- MinION

Mass SpecPromise of a Better Tomorrow

MinION, a new DNA sequencing device by Oxford Nanopore, can detect the Huntington's disease a lot faster than the traditional ways. It could therefore drastically reduce the waiting time for number of critical cases of Huntington's disease, as well as other genetic disorders in the future. Moreover, it meets the strict international quality standards for laboratory use. MinION is a small device which decodes every DNA strand separately in real-time. This handheld device can then identify the changes in any DNA sequence to detect the genetic disorder. Being able to do all of this in realtime, the device cuts down the wait time for the results.

The medical diagnostics industry is advancing at a fast-paced. The new innovations come with a promise to enhance the accuracy of detecting diseases in a human body in real-time. Moreover, the ease of use, simplicity in manufacturing as well as the affordability of the latest devices is improved. -Aishwarya Nawandhar, Editor

Colorimetrix Bringing Lab Diagnostic Tools to the Hands of Everyone

Our

to help consumers with mi direct ssionaccess is to healthcare tools they can use at home

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riven with the passion of ‘Making diagnostic lab tools accessible to everyone’, Colorimetrix was established in 2014, and oﬃcially started commercial operations in 2017. Colorimetrix decided to help women seeking to get pregnant with their ﬁrst product ‘Pearl Fertility’ released to the market in 2018. Since then, its drive has been the same, to bring knowledge forward, where it is most needed, in the hands of consumers seeking information about their bodies in a more personalized and understanding way.

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Dominik Westner | CTO Dr. Leo Martinez | CEO

of Innovators under 35 by the MIT Technology Review in 2014 for the technology. Mr. Westner, on the other hand, is a seasoned software entrepreneur, with a successful exit to Blackberry in 2011. They both are spearheading Colorimetrix with their inimitable talent and have achieved milestones together to bring ‘Pearl Fertility’ to the market (www.pearl-fertility.com). The Story of Colorimetrix

‘Pearl Fertility’ is a self-monitoring kit to test hormones at home. Women can see their hormones rise and fall during their cycle and get personalized information. For couples who are trying to conceive, this is crucial, as knowing when the fertile days are based on reliable accurate predictions, can lead to kick starting a new, wonderful journey. About the Duo Dr. Leo Martinez is the CEO and Dominik Westner is the CTO of Colorimetrix. Dr. Martinez was included in the list

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Colorimetrix started as a small project, as the lab in pocket or pocket diagnostics. While Dr. Martinez was working in the lab, he broke a spectrophotometer machine, which is a very expensive and bulky machine, which made him realize that most of the machines required in healthcare procedures are heavy, weight-wise as well as cost-wise. He then started dreaming of making them obsolete with software and small hardware and then realized that almost all they do is already included in a mobile phone. Since then, Dr. Martinez and his partner Dominik started working on multiple

applications of the technology. The number of potential applications was vast and broad, after a lengthy process of defining the product that is when finally the decision was made to go with Pearl Fertility- Colorimetrix’s firstn product, ovulation and fertility tracking at home, the first fertility test that includes up to three individual hormones. Awards and Recognitions Apart from the MIT Innovators under 35 Award, Colorimetrix holds the ‘Seal of Excellence’ from the European Commission for top SME companies. The company has also been a part of the ‘Mass Challenge Accelerator in Switzerland’ and is a Grantee of the EITHealth in Europe. Colorimetrix was also a part of the Google Launch Pad for startups in Germany, and has gained recognition in various pitching events in Europe.

immediately classiﬁed as infertile because of the lack of consensus and the lack of knowledge in the fertility space. In reality, there are several conditions that aﬀect fertility, and it does not necessarily mean they make you infertile, some are treatable and some may just lead to one taking longer journeys to conceive, but not necessarily make one infertile or in need of IVF right away. The company believes that patients are often left alone after the doctor’s visit and the doctor tells them to keep trying back at home, but there is no way for the doctor to be there with them in those moments of frustration and despair. “The medicine of the future is the one that comes to you, when the doctor comes to you, when the lab comes to you, when the hospital comes to you. We are just providing a small piece of the puzzle in the future of medicine. That one that is personalized, predictive, at home” delivers Dr. Martinez.

Testimonials Future Plans The true success of any company is measured by the number of its happy clients. Colorimetrix has been an essential part of its clients’ journey and they speak really highly of the company’s ovulation tests kit, Pearl Fertility: “We used this product to confirm ovulation which we measure using LH test sticks. This was an easy to use testthe main catch is to remember that you’re looking for only one line to confirm progesterone, rather than the standard two lines of other positive tests!”- Amazon from Danielle “We are very happy to share with you the joy of having a baby and let you know that Pearl was of great help in the journey, every test strip we took was worth the effort”Fernanda, Nutritionist Simplifying Life of Patients and Physicians

Colorimetrix is planning to bring more interesting tools for self-monitoring at home to the market. It is also likely to expand its focus from the fertility space to other segments of concern. Also, the company is helping enterprises with solutions for their daily testing routines outside of the health space. On asking him about the positive trends going on in the diagnostic industry, Dr. Martinez said, “Diagnostics at home, that is the key, that is the trend. Not to mention that it has to be personalized, perhaps an old trend but the one so many companies forget to address still. This is what we are doing.” While talking about the future goals of Colorimetrix, Dr. Martinez said, “The clinic, the lab, the medic, comes to you, that is the future we are building up here. Fertility is our ﬁrst topic, there are many more to tap into.”

Colorimetrix says that it is easy to misuse the word ‘patient’ in the Fertility topic. The truth is that many people are / MAY 2019 /

Di gi ta lNeed to in the Space? About the Author Tania Martin-Mercado, PhD, is the Chief Technology Officer of YGEIA, a digital healthcare company focused on home healthcare and chronic disease management. She holds various degrees in IT, healthcare, as well as biotechnology and is seasoned with a lot of experience at various prestigious posts throughout the years. Being a curious soul and always been fascinated with technology, Tania has been a part of various healthcare innovations. 28 / MAY

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Adroit Outlook

Tania Martin-Mercado Chief Technology OÂ¶cer YGEIA

/ MAY 2019 /

e hear a lot of buzz in the industry and in the marketplace about the latest in digital From artificial intelligence, machine learning, remote patient monitoring and wearable healthcare. technology to home monitoring and data, data, data – digital healthcare has morphed into of the most transformative healthcare one trends. While this is one of the most exciting times to be in the digital healthcare market, startups focused on this space need to make sure their product and service have three-fold impact: Improved patient outcomes, reduced cost of delivery, and quality of care. Cost, quality and patient experience often go unnoticed or ignored in favor of technical functionality. The latest and greatest digital healthcare technology will fail if the patients don’t understand how to use it, providers can’t implement it into their workflow, and payors won’t reimburse for its use. By starting with a patient-centered focus, digital startups will find they may need to slow down and get a better understanding of the healthcare industry, which operates differently than the tech world. There are more stakeholders in healthcare that need consideration: doctors, patients, insurers, regulators; each of these stakeholders holds a unique perspective on the technology being adopted. Healthcare is complex because patients are complex. As digital startups focus on one area, such as a particular disease, they may stumble onto the multiple factors that contribute to that disease, what insurers do and don’t cover related to that disease and its symptoms, and more variables that directly or indirectly affect their product or service. The development of a product or service requires research into clinical practice, medical study, patient and doctor interviews, and several focus groups. Digital healthcare startups need to have patience – something that is unattractive to some investors, causing digital healthcare startups to rush into product development too quickly. Instead, involving key stakeholders early in the development process and fully understanding the concerns and perspective will allow these startups to impact the healthcare space where it matters most – patient care. The Medical Futurist published a fantastic article earlier this year that highlights why healthcare startups fail. Forgetting about the patient, not including the provider, difficulty creating clinical value and overclaiming what the technology can do area just a few of areas discussed in this article. Another area often overlooked by digital healthcare startups is the need to integrate. Healthcare data is massive, and there is no “central repository” to draw from. By understanding and embracing the need for shared services, integration with other startups or providers in the healthcare industry can foster innovation and better meet patient need or demand. Instead startups may focus on siloed solutions that make it difficult for providers to implement into their practice, thus not offering value to the patient. By understanding how patient data is viewed from a provider and payor perspective, digital healthcare startups will find out how their product or service will be most useful. This is such an exciting time to be in the healthcare space. The satisfaction of making a positive impact in communities by improving patient care is why many startups dive into the healthcare space. By taking a few of these points into consideration, digital healthcare startups will find their endeavors bearing fruit.

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Genomic Expressio Improving Care and Saving Lives n

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on the patient first We em phasize and aim to create a company that respects the individual

Today, the company has top placements in Women’s

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eadquartered in Beverly, MA, and founded in 2012, Pedersen Genomic Expression a prominent an d Gitte | CEO &isCo-founder organization that sequences RNA to identify the best drugdiversity for the patient and the best patient for the drug. The company is spearheading with a vision to revolutionize healthcare by truly individualizing it, which in oncology means selection of effective treatments that either cure cancer or at least make it chronic and not a death sentence. The company was established by Gitte Pedersen, the CEO and Co-founder, and her brother Morten Pedersen, after their mother was diagnosed with cancer. Gitte and Morten both are scientists and they knew that the diagnosis was a death sentence if they followed the standard of care guidelines. As a result, they searched for a better drug in clinical development. However, in order to figure out which clinical trial could potentially benefit their mother, they needed to better understand the tumor’s genetic profile. For that, they looked for a tool that could do the analysis on a large scale and such a tool did not exist. This gave them a kick-start to incept Genomic Expressions.

Founders Network, XTC (Richard Branson), Molecular Tri Conference, Red Herring,and MedTech Innovator. It has also been felicitated with the ‘Lyfebulb-Helsinn Award’, ‘EIC Life Science Award’, and ‘EUTop50’, and Gitte has presented at the European commission as well as at the United Nations.

embraces

A Journey that Brought Innovation Genomic Expression was started with a large grant from the Danish Government as the diagnostic partner of “Genome Denmark”. Gitte and Morten then leveraged that success to raise its first round. With just a patent and an idea in hand at that time, the team travelled over the “valley of death” by raising grant money. Today, the company has 4 fully funded clinical programs validating its platform - OneRNA™, in four different cancer types with a strong focus on women’s cancer first all funded by grants. Genomic Expression could achieve this level of backing because of its ground breaking data. “We identify marker for a handful of already approved drugs in 100% of the

patients by sequencing RNA instead of DNA. This is true in any cancer type. In a world where only 1 out of 4 cancer treatments actually prolongs life, we believe we can greatly improve outcome and reduce recurrence, and that is what we want to prove in these clinical programs,” asserts Gitte. She further continues saying, “We also believe that treating patients with drugs that actually work as a first line of treatment will decrease cost of care, since managing the side effects for some of the more toxic drugs are expensive, and cost of losing mothers and fathers is significant cost to the society.” Happy Clients at Genomic Expression OneRNA™: A Unique Flagship Product of the company Genomic Expression’s OneRNA™ sequencing platform enables a paradigm shift from ONE disease, ONE marker, ONE drug to ONE patient, MANY markers, MULTIPLE treatment options that go beyond drugs by sequencing RNA and linking data to treatments. OneRNA™ is positioned to disrupt the current standard of care paradigm which only prolongs life for 1 out of 4 patients in oncology, while we are spending $100 billion on drugs and 8 million patients die. Using the existing drugs as the toolbox, the company believes that it can prolong life for most patients and in contrast to drugs, clinical approvals can be obtained in less than 12 month. Thus, this paradigm shift is a breakthrough because itcan select the best drug for the patients’ real-time problems. For an instance, new drugs get approved or enter into clinical trials all the time and if there is a match between the tumor and this new drug, information can be pushed to the patient’s doctor. Besides, OneRNA™ is a platform that integrates workflow from RNA extraction in FFPE samples, proprietary RNA-seq library generation, using Illumina sequencing and proprietary algorithms to analyze the data and several proprietary databases. It enables the identification of aberrantly expressed genes through to the clinical interpretation. This platform is exponentially scalable and can be moved into other indication with an update to the clinical database. The development of this platform has been enabled by Next Generation Sequencing and AI/Big data analytics. Until now, the company has raised +$6.5M in grants to validate OneRNA™ in 4 types of cancers, from the Danish Innovasion Fund, EuroStars, and Horizon2020.

The true award for any company is its happy clients. Genomic Expression has received numerous positive feedbacks from its satisfactory clients. “Measurement of gene transcription through quantitative measurement of RNA sequencing, as made possible by Genomic Expression’s approach, will add significantly to current methods to characterize the molecular features of individual cancers and guide personalized therapy.”- Dr Shridar Ganesan, Rutgers Cancer Center “Being able to identify responders and non-responders to novel treatments by analyzing blood in combination with the OneRNA™ platform has the potential to further improve care and reduce cost. Being able to substitute a highly invasive and expensive biopsy with a blood-based biomarker assay is not only beneficial for the patient, but also potentially able to reduce cost of care.”- Dr Jonathan Hernandez, The NCI Future Plans Genomic Expression would be launching OneRNA™ this year while its mission is to get the test into standard of care in women cancer first. The company has at least three data packages that are being published over the next couple of years. The company is planning to expand internationally and wishes to address all cancer indications where there is an unmet need, through partnerships and also by raising additional capital. The company can also move into other indications, such as autoimmune inflammatory diseases and all the way to health monitoring and would be focusing more on revolutionizing the healthcare system. / MAY 2019 /

Medcloud Centralizing Data for Decentralizing Care

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Medcloud aims to Offer t h e n e x t g en er at i on of Cl o ud services for Diagnostic M a n a g e m e n t , by accel erati ng t h e transit i on of diagnostic c e n t e r s a n d hospi tals to t h e Cl o ud

echnologies like Cloud and I.A has been determining the future of almost all the industries and the diagnostic solution industry isn’t different. The big volume of data, the instant access of information and the constant increase of computation power has enabled a new era for I.A in Healthcare. One such eminent company that has integrated these technologies its functioninginis Medcloud. Cloud and I.A is a natural move for Medcloud. Headquartered in São Paulo, Brazil, with its operation center in Rio de Janeiro, Medcloud was established in the year 2012. PACS and medical systems imaging has been pretty much the same for the past 25 years. Interoperability issues, high costs, and a lack of understanding about the role of the patient in a diagnosis context. These points have defined limits for the patient-doctor relationship and barriers for radiology workflows. Medcloud is committed to revolutionize that through a care-coordination solution that improves workflows for providers and integrates doctors and patients to a better care. As diagnosis has been a part of the patient journey, it is working on empowering millions of lives

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Dimas Francisco Silva Jr. | CEO

through a worldwide imaging center cloud platform. The Unique Products and Services Offered For imaging centers, Medcloud is a patient-centered platform for diagnosis, focused on simplifying test management in all its phases. Unlike other medical imaging solutions, Medcloud offers customizable and integrated solutions for any kind of medical tests, combining in a single application all the required tools for diagnostic teams and a mobile way to share the test results. Using its patient- doctor portal, patients can listen to the voice of a radiologist explaining test results in simple terms, keeping medical history centralized and sharable. The company has developed a cloud platform solution for tests and medical reports. Some of the features of this platform are: Send or receive tests from any location easily, nogirts them fulltime with automated backup routines Access tests, anytime, anywhere, through a eflblexi management and reporting tool Share tests with patients and doctors, engagingm het through a modern patient portal and App

Medcloud respects the privacy of patient data and has ways of using clinical, demographic and statistical data in the prevention of diseases and monitoring of chronic patients. Besides that, Medcloud has its own I.A engine in order to help radiologist on their daily basis workﬂow.

The beneﬁts of this technology can be found not only in the optimization of clinical workﬂow but also by providing a secure, reliable and uncomplicated way patients can access their test results and share with their doctors. The business model used by the company is SaaS having the diagnosis clinics as their main clients. As the solution is almost plug and play, the laboratories and diagnosis clinics can have a very fast tool to enhance service and provide a closer care of their patients, while at the same time reducing costs. “We’re delighted to see day by day a large number of healthcare companies experience a more secure and intelligent way to manage, store and share clinical data,” says the CEO. Furthermore, the platform can be used as healthcare marketplace and for that the company is currently working in two new developments:

The Medcloud App Medcloud’s App is aimed to provide patients with the best experience in accessing and sharing exams as well as to bring them beneﬁts with a new digital experience, such as: Ÿ Accessing all exams in real time, anytime, anywhere Ÿ Keeping medical history centralized. It can be shared with a new doctor when necessary Digitally interacting with a specialist in a virtual pe-r appointment Listening to the voice of a diagnostician explaining results in simple terms test Ÿ Full-time storage of any type of m axes Ÿ Easy re-appointments and improvement of the DoctorPatient relationship By prioritizing the patient at the center of all processes, clinics adopt a loyalty approach, creating a digital interface for the engagement of patients and health professionals. Medcloud can be integrated with any equipment, software or medical device and drastically reduces the use of printed media by the clinics, favoring the environment with the digital sharing of diagnostics.

Clinical trials – MedCloud empowers patients to have access to the information in tests. The system can be transformed into a platform to gather information for clinical trials. Patients can easily decide whether to grant access to the results of their test in exchange of ﬁnancial compensation for the use of this information in clinical trials. It is a direct channel to valuable information that can help many studies. Medical Labor marketplace – Diagnosis clinics and laboratories can use the platform to hire remote skilled medical labor to work on tests and diagnosis. Also, thanks to the large volume of information and approaches of Data Science and Big Data, Medcloud provides trivial means of research and scientiﬁc analysis for the sake of good health.

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The Passionate Leadership Medcloud was founded by Dimas Francisco Silva Jr. who is currently the CEO. Dimas is passionate about great products, teams, and patient experience. He thinks that great products are like a good music. Speaking highly of this team, he asserts, “It’s an easy and lovely experience and doesn’t need any previous instruction in order to enjoy it. In order to enable great products, he thinks that only a good orchestration process and a team could deliver such level of quality. In other words, only a good orchestra could provide a good concert. Only a compromised and devoted team could create a winner service.” Notable Awards and Accreditations Medcloud has received the following awards over the last years: Brazilian Pharma Solutions @ Biominas Brasil 2018 1st place in the Mapping of Innovations carried out by Apex- Brasil, Abiquiﬁ and Biominas Brazil. Frost & Sullivan’s # 1 Cloud-Based Medical Solution ni Latin America,’ 2016 Best Practices Award, more than an award, this title was a conﬁrmation that Medcloud has been on the right track to achieve its moonshots. Also, Medcloud is the only 100% Cloud Platform in the market with ANVISA and HIPAA compliance accreditation. The Brazilian Health Regulatory Agency (ANVISA) is an autarchy linked to the Ministry of Health; this is huge and

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very important for Medcloud’s clients. More than offering a great product, the company aims to provide a safe place to store PHI (Personal Healthcare Information). Bright Future of Medcloud Medcloud had an exponential growth in the past year. The company is already operating in 19 states inside Brazil, and has special projects in Uruguay, Chile and USA. With that vision, Medcloud has created a new class of products and services. “I.A and Cloud is a natural and required move for ALL diagnostic centers, clinics and hospitals around the world,” says Dimas. Its desire to conquer the international market has been influenced by its minority partner; an investment fund from New York called Startup Health. Through Startup Health’s coaching and acceleration program, Medcloud managers had the opportunity to see that the innovation environment outside Brazil offers a wide range of possibilities. And the company is currently evaluating possible internationalization scenarios, like Europe, Africa and more countries and North and South America. Also, Medcloud has been partnering with important Teleradiology and Telemedicine groups across South America, to offer their services in a more clinic-oriented way. The goal here is to enable diagnostic centers and hospitals to experience the Cloud and I.A services through a medical and service perspective, rather than a software experience.

Never Miss a Dose M Medication Apps obile phones, especially smartphones, are doing more than what they were intended to do. Thanks to all the apps that developers around the world are busy to simplify the lives. These mobile apps come in all shapes and sizes and making myriad of things for smartphone users. While gaming, social media, and retail apps do a the charts, continue rule to health apps are surely catching up. With people becoming more health conscious than ever, these apps are also making their mark.

Good health is attributed to many factors. One needs to have a proper diet, exercise, routine checkups, and the likes. What most people tend to neglect intentionally or unintentionally is the medication routine. Medicines, be it a lifesaving drug or just a vitamin pill, is also essential for good health. Unfortunately, most people tend to forget taking their pills on time. Some blame it on their schedule, some don’t find the time, some are too busy to remember, and some, like the elderly, just forget to take it. According to a report published in Annals of Internal Medicine, September 2012, America loses $100 – $289 billion in a year due to medication non-adherence. The situation is graver in case of chronic illnesses. Treatment of such disease requires long-term use of medicines. But patients are seen not adhering to it due to various reasons. A study from Mayo Clinic states “approximately 50% of patients do not take their medications as prescribed.” This amounts to not only monetary loss but also health issues. Some patients end up in emergency rooms because they did take medicines on time. Even small issues turn into serious ones if not treated properly. Doctors have long been advising people to take their medicines as prescribed. But the results just don’t match up. Keeping a digital eye on health Mobile apps are now being used to fight this underrated health concern. A huge population of these patients uses smartphones. Mobile apps are now being recommended by doctors and other patients alike to tackle this menace. These apps are easy to use, mostly free, and are designed to perform a lot of things for the patients. These apps have a number of features to assist patients with drug adherence. The process is simple and starts with the patient uploading their prescription or filling in the drugs that they are on. They can then customize alarms, set up emergency numbers, put a tracker, and other such features. Some apps even use games to help patients understand the importance of taking medication on time.

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Editor's Angle

Apps full of features Different apps offer different features and sometimes address only a particular concern. Some apps are free of cost while some are premium and offer much-advanced features. But most apps do the following: Set up reminders -- Easiest way to get your dose on time is to set up alarms. The apps set off alarms at a deďŹ nitive time and some even light up the screen with particular colors to remind the patients of their pending dose. Some even auto-adjust to the time zones, so that the patients do not mess up their dosage when traveling to different parts of the world. Send messages to caregiver -- Some apps send messages to the patientâ&#x20AC;&#x2122;s caregiver (mostly family member) and doctor when they miss a dose. They can then remind the patient to take their medicine.

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Manage family health -- Some apps can help patients deal with multiple profiles. This allows one member track the medicine habits of the entire family. Drug Interaction – Few apps have the feature to let patients know about drug interactions i.e. if any two or more of one’s medicines can react and cause issues to his/her wellbeing. This feature can really help if one takes over-the-counter drugs with prescribed medicine. Medical Jargons – Mobile apps can let patients understand medical terms too. Terms like CR (Controlled Release) printed on the medicine can often be confusing for patients. These apps help them crack such codes. Refill reminders – These mobile apps remind patients in advance when they are about to run out of their prescribed medicines. Contacting Pharmacy -- A few apps let patients upload their prescription with the pharmacy and get their medicines door-step delivered when they need it. They even allow the pharmacy to cross-check with the patient’s doctor to make sure that the prescribed medicines need to be continued. Generic Report – Some medicine mobile apps also let patients record their blood pressure, sugar levels and send them to their doctors at a fixed time interval (say once in a month). These mobile apps are really proving to be a boon especially for the elderly and those suffering from chronic illnesses or illnesses like Parkinson where the patient genuinely forgets to take the pills. Timely reminders, interactive interface, easy-to-use and manage features, sounds and lights, all make them suitable for patients across the world. Some paid and advanced apps even let patients take a video consultation with their doctors. The world is getting smarter and better. The world of medicine apps is slowly recognizing the opportunity and what this market can be in the future. Such apps are surely going to make this world a healthier place! -Sneha Sinha, Editor

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