Issue 06 2023
Clinical Benefits
The Importance of Personalized Healthcare in Diagnostics
Diagnostic 10Best Solution Providers in 2023
Fundamental Aspects
Diagnostics are Aided by Digital Technologies
MikeMartens ScientificBusiness Executive FutureDiagnostics
GiftingTransparent, AccurateandReliable DiagnosisintheIVD Industry
Be er Health and a better way of life.
Effectivepatientcareservicesarecrucialin
diagnosticsolutions,astheyensurethatpatients receivetimely,accurateandappropriatecare.In thisnote,we'llexploresomeofthekeyelementsof effectivepatientcareservicesindiagnosticsolutions,and howtheycanhelpimprovepatientoutcomes.
Oneofthemostimportantelementsofeffectivepatientcare servicesindiagnosticsolutionsistimelydiagnosisand treatment.Thismeansensuringthatpatientsreceive diagnostictestsandproceduresontimeandthatthey receiveappropriatetreatmentassoonaspossibleafter diagnosis.Timelydiagnosisandtreatmentcanhelpprevent thespreadofinfectiousdiseases,reducetheriskof complicationsandimprovepatientoutcomes.
Effectivepatientcareservicesindiagnosticsolutionsalso requirecoordinationofcare.Thismeansensuringthat patientsreceiveappropriatecarefromallthehealthcare providersinvolvedintheircare,includingdiagnostic specialists,primarycarephysicians,andotherspecialistsas needed.Coordinationofcarecanhelppreventerrorsand delaysindiagnosisandtreatmentandcanimprovepatient outcomes.
Finally,effectivepatientcareservicesindiagnostic solutionsshouldbepatient-centered.Thismeansensuring thatpatientsaretreatedwithrespectanddignity,andthat
theirpreferencesandvaluesaretakenintoaccountwhen makingdecisionsabouttheircare.Patient-centeredcarecan helpimprovepatientsatisfactionandengagement,andcan leadtobetterhealthoutcomes.
Inconclusion,effectivepatientcareservicesareessentialin diagnosticsolutions.Byensuringtimelydiagnosisand treatment,accesstoinformation,patienteducationand support,coordinationofcare,andpatient-centeredcare, healthcareproviderscanhelpimprovepatientoutcomesand ensurethatpatientsreceivethebestpossiblecare.As technologycontinuestoevolve,wecanexpectpatientcare servicesindiagnosticsolutionstobecomeevenmore effectiveandpatient-centered.
Providers2023wewalkyouthroughthecompanieswhich aretransformingthehealthcareindustrywiththeir experienceandefficiency,prioritizingtheneedsofthe customers.
Hope you have a good read!
-PoojaShah
Acarix AB acarix.com
Helen Ljungdahl Round President and CEO
AccuGenomics, Inc accugenomics.com
Nick Lazaridis President
Acarix AB is a Swedish medical device company that innovates solutions for rapid AI-based Coronary Artery Disease (CAD) rule-out
AccuGenomics, Inc is a developer of a unique spike-in control technology that dramatically improves the accuracy and performance of clinical sequencing tests.
BriaCell briacell.com
Charles Director
BriaCell is a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer
Cancer Center cancercenter.com
Co-Diagnostics codiagnostics.com
Future Diagnostics future-diagnostics.nl
Piotr Krajewski CEO and Co-founder
Cameron Gundry Communication
Mike Martens Scientific Business Executive
Imagion Biosystems, Ltd imagionbiosystems.com
Lipotype lipotype.com
Lumos Diagnostics lumosdiagnostics.com
Omega Diagnostics
omegadx.com
Cancer Center is commitment to high-quality, compassionate care that puts patients first.
Co-Diagnostics is passionate about providing the most robust and innovative molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications, especially to those regions where pricing is paramount
Future Diagnostics are laboratory professionals that invent, create and validate in-vitro diagnostic tests and products.
Bob Proulx CEO Imagion Biosystems, Ltd is dedicated to providing tools to find and eliminate cancer
Henri Ded Communication Officer
Kepa Oyarbide Director
Nicky Ester OP
Lipotype provide Lipidomics analysis service to help clients achieve their research goals.
Lumos Diagnostics specializes in rapid, cost-effective and complete point-of-care (POC) diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions.
Omega Diagnostics is an international diagnostics testing business that is passionate about improving lives around the world by accurately informing health decisions.
MikeMartens ScientificBusiness Executive
FutureDiagnostics
Ourdevelopment professionalsinvestigatehow todetectspecificbiomarkers, choosetherightreagentsand providethenecessaryprotocols andprocessdocumentationto makethebestpossibleIVD products.
st
Inthecontemporarytimesofthe21 century,success
andexcellencearemarkedbyeffectivecommunication andnetworking.Foranybusiness,thismeanscreating avenuesforhealthy,transparent,continuousandinstant communicationtoenableeaseofaccessforitscustomers. Thesequencesofthisstrongbondresultintrustandhappy customersthatmaximizebrandreliabilityandunique positioninginthecompetitivemarket.
Thisrightlytargetsthedemandsoftheconsumerand ensuresthatthecustomeristheking.
Onesuchcompanycuratingthisexperienceforitsclientsis FutureDiagnostics.Ithasbeengiftingreliablediagnostics testsintheIVDindustryandimmunoassayperformances forthepasttwenty-fiveyears.Italsocontributestocosteffectivehealthcarethatworksworldwide,providingits clientswithIVDteststhatmakestate-of-the-artmedical diagnosticspossible,performedwithdedication,integrity, transparency,andflexibility
Thesystemisbalancedandsupervisedundertheleadership ofitsScientificBusinessExecutive–MikeMartens,who isalsooneofthefoundersofthecompanyandis responsiblefordoingbusinessdevelopmentwith establishedcustomersandpotentialnewcustomers. Transitioningintheearlystagesofhiscareer,hegrewtobe ascientistandlaterasanR&Dmanagerandguidedthe developmentofseveralassaydevelopmentprojects,both manualaswellasautomatedassays.
Mikeandtheteam,together,arereformingdiagnostic experiencefortheirclients,devisingafuturisticexperience theindustryisabouttooffer.
Let us dive in to read more about how it has been building this for the last twenty-five years!
FutureDiagnosticswasfoundedin1997andiscelebrating th its25 anniversarythisyear.Thesixpeoplethatstarted FutureDiagnosticsallcamefromtheR&DteamofaUSbaseddiagnosticscompany,whichhadaEuropeanHQin theNetherlands.
Inearly1997,theUS-basedcompanydecidedtotransferall itsmanufacturingandR&DactivitiestotheUS.Two peoplefromtheR&Dteamdecidedtostartanewcompany
andfocusonwhattheyhadexpertisein,whichwas performingimmunoassaydevelopmentandofferingthisas aservicetotheInVitroDiagnostics(IVD)industry
ThiswasthestartofFutureDiagnostics.Twenty-fiveyears later,thisisstillthecompany'scorebusiness,directing qualitythroughitsprocesstosupplythesectorwithgood andlastingproducts.
TheFutureDiagnosticsteamarelaboratoryprofessionals thatinvent,createandvalidatein-vitrodiagnostictestsand products.Aserviceproviderandadevelopmentpartnerto biotechcompaniesintheglobalIVDmedicaldevice market.
Mikeandhisteamunderstandthatinthemedicalworld, havingtheabilitytoaccuratelymeasurebiomarkersis essentialfordiagnosingdiseases.Thesemeasurementsare donemanuallybutalsoonautomatedplatforms/analyzers. AsperMike'sobservations,whenananalyzerforIVD testingisdeveloped,itwillnotautomaticallymeasurethe desiredbiomarkers,andthat'swherehesaysthatFuture Diagnosticsappears.
Buildingonthisinformation,hesays, "Our development professionals investigate how to detect specific biomarkers, choose the right reagents and provide the necessary protocols and process documentation to make the best possible IVD products."
Besidesfullassaydevelopmentservicesformanualassays, automatedassays,PointofCareassay,andCompanion Diagnosticsassays,theyalsoprovideservicesinthe followingareas:
Ÿ ConjugationServices
Ÿ LyophilizationServices(accuspheretechnology)
Ÿ AnalyticalPerformanceStudies(Verificationand Validation)
Ÿ MultiplexArrayServices
Ÿ SmallScaleManufacturingServices
Mikeshares, "Every single one of our customers will agree: by working with our proven step-by-step action plan, we control every single part of the product development process."
Theyhavedevelopedfourstagestoreachthesetgoals:
Ÿ ContractandDefinition
Ÿ ProofofConceptandFeasibility
Ÿ Designandverification
Ÿ Productionandvalidation
ThesestepsarethepillarsthatguidetheFutureDiagnostics teamandkeepthemfocusedtoadequatelyandefficiently runtheirprocesseswithoutlosingprecioustimeandfocus.
Mikementionsthataprojectthatisbroughttothemis alwayssupervisedbytwooftheirexperts.Hefurthersays, "The expert responsible for the technical part of the IVD
product development process is constantly observing and controlling the terms of the agreement. Our second expert controls the set time frame, deliverables and overviews the costs."
Toenhancethebenefitsfortheirclients,duringthe developmentprocess,theyregularlyreporttheprogressof theprojecttothem.Also,theirSharePointenvironment enablestheirclientstohaveareal-timeviewofthe progress.Hebelieves, "It is vital to have transparent communication between us and our client to keep the development process efficient thereby saving time and costs."
ForFutureDiagnostics,Mikesaysthat,thevastexperience hasprovidedthemwithanelaborateknowledgeof numerousanalyzersandtechnologies.Heproudlyshares, "After all, we have been in business for 25 years and have seen a variety of analyzers and technologies during that time." Theirfamiliaritywithvariousinstrumentsand technologiesensurestheycanstartquicklyandefficiently withoutlosingpreciousandvaluabletimelearning.
Inthelastyearswe havebeenabletoproofthis evenmorebysettingup aSharePointenvironmentin whichourcustomersareable to"lookoverourshoulder"in respecttotheactivitiesthat weperform.
Heconveysthatthecompany'sclientscanalwayscounton high-qualityserviceand,consequentlysophisticated validatedtestsfortheirmarket.Mikebelievesthatthiscan onlybeguaranteedthroughtheprofessionalismandknowhowofthepeopleandthroughusingonlythebestavailable products.
Forthis,alloftheirproceduresaremonitoredandrecorded bytheadvancedqualitymanagementsystems,which complywithexistinglegislation.Heasserts, "Our quality professionals leave nothing to chance. In our opinion, perfection is our greatest asset." Thisenablesthemtouse theirtimeasefficientlyaspossiblewhileavoidingwasting valuabletimecorrectingerrors.
Despitetheunpredictabilityofbiomaterialsattimes,they striveforminimalwasteandmaximumresults.Hesays, "IVD development by Future Diagnostics is one crucial step of many to introduce your product to the market. Our commitment is key!"
Thisisdrivenbytheirconstantupgradationandpartnership withemerginginnovations.
AsperMike,thecompanyanditsteamhavealways communicatedthattheyperformtheirservicesinanopen andtransparentway
Expressingonthetransparentworkflow,,Mikeexplains, "In the last years we have been able to proof this even more by setting up a SharePoint environment in which our customers are able to "look over our shoulder" in respect to the activities that we perform."
Furthermore,theTeamsmeetingstheyhavesetuparea reasonablealternativeforface-to-facemeetingsandare muchbettercomparedtotelephoneconferencesforthem andtheirclients.Overtheyears,thisprofessional commitmenthasalsoenabledthemtonavigatethrough troubledwaters.
Sharinginsightsonthecurrentchallenges,Mikediscusses, "From a regulatory point of view IVD, companies have to show high standards for all their on-market products. This includes not only a vast variety of technical performance data but also clinical performance data based on several clinical studies."
MikeMartensisoneofthetwofoundersof FutureDiagnostics.Hestartedhiscareerin theIVDindustryin1991,asascientist, developingimmunoassaysfortheearlier mentionedUS-baseddiagnosticcompany. Hisinitialactivitieswerereallyhands-on, performingassaydevelopmentworkonthe labbench.Thefirstimmunoassaythathe developedwasanassaytomeasure erythropoietin(EPO).Fromascientist,he becameanR&Dmanagerandguidedthe developmentofseveralassaydevelopment projects,bothmanualaswellasautomated assays.
WhenthefoundersstartedFuture Diagnosticsin1997,hebecametheCTOof thecompany.Aftertheretirementofhis colleaguein2012,hebecametheManaging Director.Now,heistheScientificBusiness Executiveresponsibleforbusiness developmentwithestablishedandpotential newcustomers.
But,asFutureDiagnostics,heinformsthattheorganization isfocusedonthedevelopmentofanassaythatfulfilsthe technicalrequirementsofitscustomers.Hepointsout, "This is our focus."
Bymakingallianceswithcompaniesthatfocuson regulatoryandclinicalrequirements,itcansupporttheir customerswithaone-stopshopapproachbymeansthat FutureDiagnosticsisalsotakingtheregieoftheother activities,creatingopportunitiesforthemselvesandtheir clients.
Hefindsitessentialtospreadthis"happycustomer"attitude tofuturegenerationsofentrepreneurs.
Beinganexpertinthefieldandanexperiencedleaderinthe industry,Mikessuggeststhatwithrespecttotheactivities thatanaspiringentrepreneurperformsforcustomers,the individualhastostayfocusedonthatactivity.Hethinks thatinsuchaway,onecanimprovetheirservicesevery timeandstriveforproductleadership.
Tohelpthemcarveafocusedpath,Mikeadvises, "Take the comments from your customers seriously and improve your services towards them every time. Make sure that they feel themselves as a valued customer. This way, you create happy customers, and happy customers come back for your services."
InMike'sopinion,sinceFutureDiagnosticsisacompany thatperformsitsservicesbasedonits experience/knowledge,theteamisverycarefulthattheydo notgrowtooquickly
Forhim,itisveryimportantthatnewstaffistrainedina properwayanddoesgetexperienceinthelineofservices as,withoutit,hefearsthattheywouldendupwithalarge staffthathasadilutedknowledgeofassaydevelopment, whichiscrucialtothemsincetheywanttoachieveproduct leadership.Hesays, "This is very important to us and we monitor this carefully."
Mikefurtherelaborates, "Since we are also involved in Proof of Concepts of new technologies, i.e., photonic sensor platforms, we are able to expand our services and capabilities in new innovative areas that have the potency to become next generation detection technologies in the IVD industry."
Takethecommentsfrom yourcustomersseriousand improveeverytimeyourservices towardsthem.Makesurethat theyfeelthemselvesasavalued customer.Thiswayyoucreate happycustomersandhappy customerscomebackforyour services.
Ms Helen Ljungdahl Round President and CEO Acarix
Innovationinthehealthcarenichemeansinnovationin
thecompletelifecycleofmedicaldevicesfrom conceptualizationtotheendoflifeofthatdevice.This createdanopportunityforthemedicalindustrytoleapfrog andmakefundamentalchanges.
Asasignofchange,organizationshaveworkedwiththe commongoalofachievingthebestoutcomeforthepatient, andoverallvalueforthehealthcaresystemhasbeenoutof focus.Onesuchorganization,Acarixistouchingmillions ofheartswithitsgroundbreakingAItechnologywhich helpsdetectheartsoundabnormalities,suchascoronary murmursandmanymoreinlessthantenminutes.
AsPresidentandCEOatAcarix,MsHelenLjungdahl Roundhasrapidlyclarifiedthestrategy,refocusedthe companyeffortsonthecommercializationintheUS, strengthenedtheGlobalManagementTeamtodrivethe globalperformance,andhiredatoptalentwomenUS leadershipteamtodrivethegrowthintheUS.
Pleasebriefouraudienceaboutyourcompany,itsUSPs, andhowitiscurrentlypositionedasareliablefirmin thehealthcaresector.
AcarixisaSwedishmedicaldevicecompanythatinnovates solutionsforrapidAI-basedruleoutof Coronary Artery Disease (CAD).TheCEapprovedandFDADeNovo ® clearedAcarixCADScor Systemisintendedforpatients experiencingchestpainwithsuspectedCADandis designedtohelpreducemillionsofunnecessary,invasive andcostlydiagnosticprocedures.
® TheCADScor Systemcalculatesapatient-specificCAD scorenon-invasivelyinlessthantenminutesandcanhelp
ruleoutmorethanone-thirdofpatientswithatleast96% certaintyofnotbeingsick(inapopulationwithapprox.ten percentCADprevalence).AcarixislistedontheNasdaq FirstNorthPremierGrowthMarket(ticker:ACARIX).
Shedsomelightonyourofferingsandhowtheyimpact theindustryandyourclients?
Ourmissionistotouchmillionsofheartswith CADScor®System,ourgroundbreakingAI-based technologyfortheacousticassessmentofcoronaryartery disease(CAD),andaidtoruleoutthosethathavelowrisk.
OurvisionisthateveryonethatneedsaCADScor®System assessmentshouldhaveaccess.Bydoingso,wecanreduce
Iamexcitedaboutleadinga companythatisutilizingacoustic engineeringandAItorapidly assesspatientswithchestpain andhelpdetermineiftheyhave CAD.Ibelievethatwecanimpact notonlycardiovascularhealth carebutalsoprovidepatients witharapidresponseandpeace ofmind.
thediagnosticburdenonindividuals,providepeaceof mind,aswellashelpdriveefficiencyacrosstheoverall cardiachealthcaresystems.Thereareonemillionpeople withchestpainseekingmedicalattentioneachday.The difficultyistodeterminewhetherthisisrelatedtotheheart ornot,andmanygothroughmultiplediagnostictests,some alsoinvasive.
Thetroublingfactisthatnineoutoftenassesseddonot haveCAD.Injusttenminutes,theCADScor®Systemcan insteadruleoutCADinthosepresentingwithstablechest painandsuspectedCADwithatleast96%certainty.
Beinganexperiencedleader,shareyouropiniononhow theadoptionofmoderntechnologiesandplatformshas impactedthediagnosticsspaceandhowisyour companyridingthetechnologywave?
Moderntechnologyandinnovationwillcontinueto improvehealthcareandpatientoutcomes.Iamexcited aboutleadingacompanythatutilizesacousticengineering andAItorapidlyassesspatientswithchestpainandhelp determineiftheyhaveCAD.Acarixisattheforefrontof thiswave–wehavethetechnologytosupportcliniciansin theirdiagnosisofpatients,andhealthcaresystemsin drivingefficienciesandcostreductions.Still,most importantly,weproviderapidanswersandhopefullypeace ofmindforthemillionsofpeoplewithchestpainand suspectedCAD.
Whatwouldbeyouradvicetobuddingentrepreneurs whoaspiretoventureintothehealthcarespace?
Leaninandfocus.Focusonunmetneeds,developing innovativetechnologiestoaddresstheneeds.Understand theproblemyou'retryingtosolve.Designtheproductswith theendinmind.Thinkbig,developaclearstrategy,execute withpurpose,andtrackandprioritizeruthlessly.
Howdoyouenvisionscalingyourorganization's operationsandofferingsin2022andbeyond? Ourvisionistocreateaparadigmshiftintheearly diagnosisandassessmentofcardiacandvasculardiseases. Overall,weareworkingonensuringthateveryone,beita healthcareprofessionalorapatientwhowantsorneedsa CADScor®Systemassessment,cangetonepromptly We recognizethatthisisfarfromwherewearetoday,butgiven thetechnologyintheCADScor®System,thisistheright visionforustobeoperatingunderandtodeliverthe expectedgrowth.
Wearesystematicallymovingfromastart-uptoascale-up; weareataninflectionpointandfocusingonscalingupour operations,ourcommercial,andourR&Dcapabilitiesto meetimportantcardiovascularandotherunmetmedical needsandgrowthecompanythroughorganicand commercialpartnering.
Pleasegiveusafewtestimonialsofyour clients/customersandalistofawards/recognitionsthat accuratelyhighlightyourorganization'spositioninthe market.
RobinKaras,PresidentBio-RythmsInc:"Iamdelighted tobeworkingwithAcarixonintroducingtheCADScor SysteminLouisianaandMississippi.ThenovelAI-based acoustictechnologybringssignificantvaluetophysicians assessingchestpainpatients.IhavebeeninCardiology salesfor40years,andnotsinceballoonangioplastyhas,I seensuchagame-changingtechnology.Theinitialinterest andresponsefromphysicianshavebeenverystrong."
Prof.DrAndreasGötte,ProfessorofMedicineandChief oftheDepartmentofCardiologyandIntensiveCare MedicineattheSt.VincenzHospitalinPaderborn, Germany
"Usually,wehaveaveryshorttimeperiodtodoall diagnostictests.Weknowfromthelatestguidelinesthata treadmilltestisnotappropriateforischemicassessment. Forthisreason,weneedimagingtechnologieslikeCTor echo,orMRIwhicharenotavailableforthislargevolume ofpatients.It'sveryeasytouseCADScor®System,you justneedfourtimeseightsecondsofnon-breathing,and youcanassesstheflowinthecoronaryarteries.Ithinkit's veryhelpfultobeusedinpatientswhereyouwanttorule outthepresenceofcoronaryarterydiseaseorcoronary arterysclerosis.
MsKellyKolodney,PatientPerspective,USA
"Iwashavingthistightnessfeelingaroundmychestforthe
Ms Helen Ljungdahl Round is a highly accomplished execu ve with more than 25 years of leadership experience across strategy, business management, marke ng and sales in both the pharmaceu cal and medical technology industry. Her accomplishments span numerous therapeu c areas, product life cycles and geographic areas.
Her most recent posi on as CEO of Amnicell, a biotech start-up based in New York City, has prepared her well for this new opportunity, along with previous roles as Senior Vice President of Global Marke ng and Business
Development for GN Hearing in Denmark and many execu ve leadership posi ons of increasing responsibility at Merck & Co, Inc, working in North America, EU, the Middle East/Africa, La n America, and Asia. She is recognized as a strong commercial leader that has consistently built high-performing teams and organiza ons and delivered profitable and sustainable business results.
lastseveralweeks.Atnightsometimesitwouldgetreally bad.Myhusband–whoisnotanalarmist–said,"we'd bettergototheERandseewhat'sgoingon,thiskeeps happening."NotlongafterthatIhadanopportunitytogeta CADScorSystemtest.
Whenthatwasdone–itwassuchaneasyandsimple procedure–ittooknomorethanmaybe10to15minutes–IgotmyCAD-scoreanditwas13.Itjustgavemethis senseofpeaceandreliefthatitwasn'tmyheart.Iwasso gratefulthatIwasabletodothatwithouthavingtogo throughmultipledifferentkindsofexpensiveteststocome tothesameconclusion.Iwasjustamazing."
PersonalizedMedicine(PM)movesatthesamepace asdataandtechnologyandcallsforessential changesinhealthcare.Newplayersare participating,providingimpulsetoPM.Wereviewthe conceptualfoundationsforPMandpersonalizedhealthcare andtheirevolutionthroughscientificpublicationswherea cleardefinitionandthefeaturesofthedifferent formulationsareidentifiable.
Overtime,newparadigmsofMedicineandhealthcarehave beendefined.Anapproachgenuinelyfavorsthesingle personistechnicallyfeasible,economicallyvaluable,and culturally,ethically,andsociallyaccepted.Withtime,itwill becomemoreandmoreunethicalanduneconomicto delivernon-personalizedservicesconsideringtheinefficacy, sideeffects,andhighcostsofsomestandardtreatments.
Principlesofthispersonalizationcontinuumhavebeen tracedfromscientificpublicationsandcomplementedwith anassessmentofstrategicdocumentsreleasedbyEuropean
fora,whichhaveafocusonpersonalizedMedicine(PM), suchastheInternationalConsortiumforPersonalised Medicine
Let's have a look at Personalized Healthcare and learn more about it
PMisnotonlyaboutthemereindividualizationof Medicine,formulatedbyHippocratesover2400yearsago, butalsoaboutthehigherprecisionofdiagnosis,therapyand prognosisthatcanideallybetailoredtothesinglepatient andcitizen.Principlesofthispersonalizationcontinuum havebeentracedfromscientificpublicationsand complementedwithanassessmentofstrategicdocuments releasedbyEuropean
Thecurrentevidence-basedapproachmeansthatindividual patientdiagnosis,treatment,andcareoptionsare determinedbymedicalguidelinesbasedonbiomedicaland clinicalresearchandtheresultsofclinicalstudies.Withthis strategy,clinical,biological,biotechnological,and computationalbiologyexpertisearecombinedtoaidin formulatingandvalidatingthemosteffectivetreatmentand comprehendingdiseasemechanisms.
Individual-specificindividualizedapproaches:Thesocalled"networkmedicine,"whichemergedfromthe previousphase'scomputationalbiology,emphasizesearly andsubtlesignsofdeviationfromhomeostasis,patients' sensitivityandawareness,andpersonalpreferences.The personalizedapproachistailoredtopatients'characteristics, suchasthegenome,microbiome,epigenetic(precision), andlifestyleparameters.
ThetermPMfirstappearedinpublishedworksin1999, highlightinghowthenewtechnicaladvancesinpredicting healthrisks,trackingdiseasedevelopment,andpredicting responsetotherapycouldenabletailoredapproachesto care.EvolvingPManditsaspectsAlthoughtheknowledge behinditwasalreadyobservableinclinicalpractice,
TheEuropeanCouncilConclusiononPersonalised MedicineforPatientsadoptedthedefinitionthat "Personalisedmedicinerelatestothebroaderconceptof patient-centeredcare,whichtakesintoaccountthat,in general,healthcaresystemsneedtobetterrespondtopatient
needs"(2015/C421/03).Overtime,PMhasbeenacatchalltermfrequentlyusedsynonymouslywithgenomic Medicine.SincePresidentObamalaunchedthePrecision MedicineInitiative(PMI)in2015,theseideashavebeen usedtodeterminewhichtreatmentsbasedongenetic, environmental,andlifestylefactorsarebestforwhich patients.
Hood'sconceptofPredictive,Preventive,andPersonalized Medicine(PPPMor3PMedicine)waspresentedasthe beginningofanewerain21st-centuryMedicineasthe potentialbenefitsofgenomics,andPMbegantoemerge.
Theabilitytomeasure,store,andhealth-relateddatahas reachedunprecedentedcapacity,whilepublicandprivate investmentsareflourishing.Theabundanceand affordabilityofgenetictestingcurrentlyavailable,the abundanceofe-healthandm-healthtoolsinclinical practice,andwearabledevicesofferthepossibilityto measure,collect,andsharebiologicalandlifestyledata easily Theterm"3PMedicine"wasusedinthescientific literatureprimarilyconcerninggenomics,pharmacology, andsystemsbiology.Smartphonesandwatchesrecord socialnetworksandbehavior.
Inconjunctionwithelectronichealthrecords,allofthiscan provideanoverviewofhealthoutcomesatvariousstagesof life,identifyhealthrisksinindividuals,andimprovehealth outcomes.Anewhealthcaresystemconfigurationappears conceivable;wehavedubbeditthenextPHCasit develops.Wecananticipatepersonalized,predictive, preventive,participatory,andperson-centeredcare approachesinhealthcare,justastheydidinMedicine.
Thisapproachisbecomingincreasinglynecessary, particularlyinlightofglobalhealthcareemergencies,which havedemonstratedtheirabilitytounderminesocialand economicstabilityworldwide.WithpersonalizedMedicine, doctorscanprovidepatientswithindividualizedtreatments basedontheircharacteristics,resultinginbetteroutcomes andenhancedqualityoflife.
Intheyearstocome,personalizedhealthcarewillbecome evenmoreimportantasmedicalresearchandtechnology advance,revolutionizingthehealthcareindustryand improvingpatientcare.
-ShreyasiShelke
Wakinguponemorninganddiscoveringthatthe worldishitbyapandemicviruscanbe breathtaking,butsteppingbackonemust recognizetheimpressiveabilityofnature;withalong single-strandedmoleculereplicatinginsidethehuman genomicsystem,toputtheworldinperilsofglobal lockdown.
Towardsunderstandingthesignificanceofgenomic research,andperhapspartiallyattributedtoincreasedsocial awarenessfromCovid-19,moleculardiagnosticshasbeen elevatedandhighlightedinsocietyandisnowmorewidely recognizedandunderstoodbythoseoutsidethecoreofthe industry.Drivingthischange,manycompanieshave facilitatedgroundbreakingclinicalsolutionswhilefostering aneraofscientificrevolution.Trailblazingsuch entrepreneurialspiritthattransformstheworldforthe better,AccuGenomicsisexemplifyingthetruemeaningof "technologyleadership."
Asaclinicalgenomicsleader,thecompanyispositioning it'sgold-standardNGSstandardizationtechnologywiththe goalofhelpingmillionswithmoreaccuratehealthcare insights.Standingastheguidinglightonthe transformationalpathofAccuGenomicsiscompany PresidentNickLazaridis,Ph.D.
Realizingthetechnologicalmarvelsofthecompany,weat Insights Care metNicktolearnmoreaboutAccuGenomics' presentsolutionsanditsfutureroadmapahead.
Please go through the interview highlights:
Pleasebriefouraudienceaboutyourcompany,itsUSPs, andhowitiscurrentlypositionedasareliablefirmin thehealthcaresector.
AccuGenomics'smissionistoimprovetheaccuracyand performanceofclinicalsequencingtestingforbetterpatient outcomes.TherapidpaceofinnovationinNGSdiagnostics continuestopushthelimitsofdetectionforlowabundance
biomarkers,increasingtheneedtodemonstratethe analyticalperformanceofCompanionDiagnostic(CDx) testsforpatientsandhealthcareproviders.Wecreate internalstandardsfortargetedNGSassaysthatreduce uncertaintyandgivecliniciansandpatientstheaccuracyin datatomakeconfidentmedicaldecisionsbyeliminating falsepositiveandfalsenegativeresults,allowingthetrue underlyingbiologytobeseen.
AccuGenomicshasdevelopedandcommercialized technologysolutionsthatenabletestdevelopersand implementerstodemonstratethehighestperformancelevels TM oftheirsequencingassays.SNAQ -SEQ(Standardized NucleicAcidQuantificationforSequencing)enablesahost ofhighlysensitiveNGSapplicationsthatimprovevariant detectioninliquidbiopsy,SARS-CoV-2pathogen screening,andrapidadventitiousagentdetectionincell therapymanufacturing.
Nick,canyouelaboratemoreonthesolutionsand servicesprovidedbyAccuGenomics.
Wedesignandmanufactureinternalspikeinstandardsthat enableaccuratedetectionoflowabundancebiomarkers fromliquidbiopsyorothersampletypes(canbeanytarget, anyplatformandanysampletype). Weimprovethetrue limitofdetection(LOD)forNGSassayssoevenrare variantscanbeidentifiedsothatthemolecularmarkersof cancercanbedetectedearlier,evenfromliquidbiopsy samples.Theseinternalstandardsprovideimprovements acrossanumberofaspectswithNGStesting:
Ÿ improveaccuracyandenablesthemeasurementoftrue LOD,whichleadstobetterpatientoutcomes
Ÿ aredesignedtobebiochemicallyidenticaltothe variant/targetofinterest;internalstandardseliminate falsepositivesandfalsenegativeswhichimprovesthe accuracyofalltargetedNGSassaypanels
Ÿ arespikedintoeachsampleatknownconcentrations duringsampleextraction,andco-processandco-vary
AccuGenomicsisactively developingtechnology solutionsthatenabletest developersandimplementers todemonstratethehighest performancelevelsoftheir sequencingassays.
Ÿ withthetargetofinterest,providingaperfectQC workflow
Ÿ providesgold-standardreportingtopathologistsas copiesofvariant/mlofplasma
We'readisruptiveprecisiondiagnosticstechnology companythatmakestools(assayspecificcustominternal standards)thatpreciselyquantifybiologytopower moleculardiagnosticteststobemoreaccurate,standardized andharmonized,evenacrossplatformsanddecentralized testingsites.Theabilitytoimprovesensitivitywithouta lossofspecificityiscriticalinNGStestinganddiagnosis, andtheseimprovementsarerequiredtocorrectlycall additionaltruepositiveswithlowabundance(thesecanbe incorrectlycalledasfalsenegativesifusingpre-defined
NickLazaridis Ph.D., President AccuGenomics,Inc.
thresholdalgorithmsprovidedfromDxtestmakers).The useofinternalsyntheticstandardsthatbiochemicallymimic thevariantofinterestcanprovideadirectorthogonal measurementtodetermineatarget-specificLODforeach sample,effectivelytuningthedetectionlimittoeach sample.
Withourcollaborators,wehavedemonstratedanincrease of3-5-foldbettersensitivitywithtargetedNGSpanels, alongwiththeeliminationoffalsepositivesandfalse negativesthatwouldotherwiseleadtoinaccuratevariant callsandpatienttreatments.Useofinternalspikein standardshasadifferentiatedpositiveimpactonprecision medicineprograms,andsomeofourpharmapartnersare findingstrongvalueofthetechnologyfortranscript abundancemeasurements.
WepartnerwithlabsthatrunNGStestsandmaketheirtests moreaccurateandclinicallyrelevant. Ourbusinessmodel issimple;designandmanufactureclientspecifiedinternal spikeinstandardsthatimprovetargetedNGStests,and providethematscaleandatapricepointthatenables adoptionacrossapplications.
Beinganexperiencedleader,shareyouropiniononhow theadoptionofmoderntechnologiesandplatformshas impactedthediagnosticsspaceandhowisyour companyridingthetechnologywave?
TheSARS-CoV-2pandemichaswidelyopenedthemarket toaddresstheuniqueneedsofourclientswhenitcomesto sequencingtesting.Wehavebeenabletodevelopmultiple internalstandardsforallcurrentlyidentifiedSARS-CoV-2 variantsformultiplesequencingmethodsandplatforms, andhaveadvancedthisevolvinglandscapeofSARS-CoV-2 NGStestinginparalleltoadoptionofourtechnologywith ourclientsfocusedononcologyclinicaltests.
Whatwouldbeyouradvicetobuddingentrepreneurs whoaspiretoventureintothehealthcarespace?
Self-beliefandhardworkarealwaysgoodformulasfor success.Surroundthemselveswithotherentrepreneursthat canprovidegreatcoachingtoventureouttheirideasinthe healthcarespace.Beflexiblewiththeirventureandadapt tomarketunmetneeds,identifyandexecuteastrategythat addressesthoseneeds.
Howdoyouenvisionscalingyourorganization's operationsandofferingsin2022andbeyond?
LeveragingourgrantawardsfromUSAirForceand NIIMBLwillbringnewopportunitiestoadaptour
technologytoclinicalsequencingtesting.Afocusonour client'sprecisionmedicineunmetneedsonsequencing methodstodetectminimumresidualdisease(MRD)will giveustheopportunitytobecometheleadersin quantitativesequencingtesting.Thesenewopportunities willhelpusaddheadcounttoaddressourinternalneedsin designingandmanufacturingstandards,andalsoenable addingadditionalsupportforsalesandmarketing.
Pleasegiveusafewtestimonialsofyour clients/customersandalistofawards/recognitionsthat accuratelyhighlightyourorganization'spositioninthe market.
MostofourclientsoperateunderCDAsowecannotreport theirresults.Wecansaythatthereisalotofexcitement whenweshowthemhowmanyfalsepositivesandfalse negativesweeliminatefromtheirNGSmethods.In additiontoourannouncedgrantsfromtheUSAFand NIIMBL,we'vealsoparticipatedintheFDASEQC consortiumandattheNCBioneerventurechallenge. Of commercialimportance,weareactivelyworkingwith numerousclientsthatincludepharmaceutical,CRO, diagnostictestmanufacturers,andsomeoftheleading academicinstitutions.
ArtificialIntelligence(AI)holdsstrongreasoning powerandindependentlearningproficiencywhich canstimulateand enhance the critical thinking ability ofahumanbrain.Thesefundamentalsexpandits reachtoalltheindustries—thehealthcareindustrybeingno exception.
AIexcelsinrecognizingcomplexpatternsinlargedata volumes,extractingtherelationshipsofcomplexfeaturesin therecords,andidentifyingcharacteristicsinthestatistics thatthehumanbraincannotperceive.
Lookingattherecentdevelopments,AIisalready extractingpromisingresultsinradiologyandoncology.The cliniciansuseprogrammedmachinestoprocessimages rapidly,thusassistingtheminfocusingtheirtimeonthe crucialfundamentals—forwhichtheirtechnicalexpertiseis essential.
IntegrationofAItechnologyinthe treatment of severe diseases like Cancer improvestheaccuracyofdiagnosis andfacilitatesclinicaldecision-making,leadingtobetter healthoutcomes.AIguidedclinicalcareplaysa comprehensiveroleinlesseninghealthinconsistencies, especiallyintreatingseverediseases.
TheexponentialgrowthofAIinthelastdecadeis evidencedtobeapotentialplatformforoptimaldecision makingbysuper-intelligence—AI-basedalgorithmshold greatpromisetopavethewaytocomprehendtheunusual geneticmutationsandaberrantproteininteractionsinthe initialstage.
AI-basedassistancetopathologistsandphysicianscouldbe agreatleapforwardtowardthepredictionofrisk, diagnosis,prognosisandtreatmentsoflife-threatening diseases.
Clinical applications of AI and Machine Learning (ML) in cancer diagnosis and treatment are the future of medical guidance towards faster mapping of a new treatment for every individual.
Inotherwords,usingadvancedmachinelearning techniquesinmedicalimagediagnosisonaregularbasisis thenextbigleapthatoursocietyneedstotransformitself towardsnewhorizons.Certainly,CancerCenter.AI facilitatesthistransformation.
UndertheleadershipofPiotrKrajewski,CEOandCofounder,CancerCenter.AI'sstate-of-the-arttechnology substantiallyimproveshumanhealthconditions.
Inaninterviewwith Insights Care,PiotrKrajewski highlightsthecontributionofCanerCenter.AIinconnecting biologywithArtificialIntelligence.HeexplainshowAIbasedassistancehelpsoncologistswithprecisetreatments.
WhatarethecoreaspectsofCanerCenter.AI,andwhat isitsvisionandmissioninthehealthcareniche?
Incancerdiagnosisandtherapy,medicalimageprocessing andanalysisneedthecombinedopinionofmanyexperts.
Toclarify,pathologists,radiologists,geneticistsand oncologistsworktogethertofindthebestsolutions.
Firstly,theamountofdataishuge.Furthermore,theoverall decisionprocesstakesalotoftime.However,thereisa cureforthisdisorder.Secureandcompliantcloudplatforms
withalgorithmsbasedoncollectingbigdatasolvethe problem.Bothtoolsenablepatientsanddoctorstoshare images.Mostofall,theyprovideanautomated,accurate pre-diagnosis.
Ouraimisto makehigh-qualitycancer diagnosisavailableanywhere intheworld,regardlessof whetheryouliveinarichor poorcountry.
Whatarethechallengesinprovidingcancertreatment andcomprehendingtheseadversities,howdoes CancerCenter.AIthrivetowardstransformingthis scenario?
The current diagnostic workflow around the world is as follows:
First,adigitalscanistaken,usuallyusingMRIorCT scanners.Next,aradiologistexaminesthescanlookingfor signsofatumor.Iftheresultlookspositive,abiopsyis taken,andaPathologistexaminesthesampleundera microscope.Ifthatexaminationispositive,thenapanelof doctorsmakesadecisiononthetypeoftreatment.The diagnosticworkflowmayberepeatedmultipletimesduring atreatmenttoassessthetreatmentoutcome.
Themainchallengeinthisareaisthatthediagnostic processistoolong!
Thefirstreasonisthatcurrentlytherearenotenough pathologiststohandlethisworkload;itisamanualprocess; manydepartmentsusemicroscopeswithoutdigitalslides andsendslidesbypost,inparticularwhenasecondopinion isrequired.Manypathologistsdonotusestandardized reports.Therearemistakes,andtheprocessisveryslow andexpensive.
Thereisamajorshortageofradiologistsandpathologists fromadoctor'sperspective.Aboutfivetimesmoreare neededtocopewiththecurrentdemandaroundtheworld. Also,theprocessreliesonaninefficientdisjointedsetof legacytechnologies.
Fromdatascientistsandinnovators'perspective,it'shardto obtainuptodate,high-qualitydatasetsneededtotrainand improvealgorithms.Anidealsolutionwouldbea diagnosticprocessthatisfast,cheapandmoreaccurate.
OuranswertothesechallengesisatoolfordigitalizationPathoCam and a cloud platform - PathoPlatform thatwill enableoncologists/pathologistsandinthefuture—patients tosharetheircasestoprovidecancerdiagnosissupported byAI.
Oncethesystemisinplace,theprocesswillbefivetimes moreefficientthanitistoday.Bothdoctorsandpatients willhaveaccesstoapoolofexpertstogainasecond opiniontovalidatethediagnosis.
Our vision is to foster an ecosystem of apps and algorithms connected by APIs, of which we aim to be the gatekeepers.
Datawillbeownedbythepatientandavailabletodoctors inaccordancewithGDPRandothermedicalInformation Governanceregulations. Our aim is to make high-quality cancer diagnosis available anywhere in the world, regardless of whether you live in a rich or poor country
WesupportOncologyDiagnosis(pathologyandradiology) inbetterandfasterdiagnosisusingAI,DeepLearning(DL) andMachineLearning(ML).UsingAIandDeepLearning inCancerDiagnosismakesthewholetreatmentmuchmore efficient.Specializedalgorithmicsolutionsanalyzemedical imagesforpathologyandradiology
WhatsolutionsdoesCancerCenter.AIoffer,andhowdo theseofferingssignificantlyimpactthehealthcare industry?
Wewouldliketohelppathologists,radiologistsand oncologistswithabetterandfastercancerdiagnosis.For that,weuseDeepLearning(AI)andSoftwareTools.Inthe secondhalfoftheyear,wearegoingtoofferaMedical SecondOpinionplatforminoncologyforpatientsalso.We havedevelopedspecializedalgorithmicsolutionstoanalyze medicalimagesforPathologyandradiologywithfasterand betterthanhumanaccuracy
Oursolutions,whicharebothinAPIandWebPlatforms, aredesignedtoofferfasterandbetteraccessforsecondand thirddiagnosticopinionsbymedicalprofessionalstohelp developatherapeuticapproachquickly.Thiswillhelpthe patientsandphysiciansbyreducinganxietycausedbynot knowingwhattheyaredealingwith.
Oursolutionsdoallthework—segmentimages,find regionsofinterest,generatestatisticaldescriptionsof images,countcells,mitosis,andevenrecognizethetypeof cell.
Weprovidedoctorswithallthenecessarytoolstowork withmedicalimages.Toclarify,weconnectthenew technologyofmedicalimagingandthemostadvancedand futuristicsolutionsfromthefieldofmathematicsand computerscience(machineanddeeplearning).Cancer Centerappliesdeeplearningtechniquestothefieldof oncology/radiology
Ahugetrainingsetofmedicalimagesalongwith categorizationtechnologyallowcomputerstopredict multiplediseaseswithbetter-than-humanaccuracy.
Piotr,enlightenourreadersabouttheinspirationbehind theestablishmentofCancerCenter.AI.
Jakobisourtrueinspiration.Hewasluckytowinhisbattle withcancer.Becauseofhim,wehavelearnedfirsthandhow inefficientandslowtheprocessofcancerdiagnosisis.This istosay;incancerdiagnosisandtherapy,
thedecision-makingprocessneedsthecombinedopinionof pathologists,radiologists,geneticistsandoncologists.
Inaddition,theamountofdataishugeandtheoverall decisionprocesstomakethefinalconclusiontakesalotof time.Likewise,theshortageofexperiencedoncologistsisa worldwideproblem.Thesameiswithradiologists, pathologistsandgeneticists.Beingengineersand entrepreneurs,wedecidedtodosomethingaboutit.
Beinganexperiencedleader,shareyouropiniononhow theadoptionofmoderntechnologiesandplatformshas impactedthediagnosticsspaceandhowisyour companyridingthetechnologywave?
Whenwestartedthisproject,itwasnoteasytofind oncologistswhowouldliketoapplyAIintheirjob.Nowit ismuchbetter.
DuringCOVID,manyoncologistshadtoworkremotely, andtheysawthevalueofthiskindofproduct.Additionally, wehelpthemtodecreasetheriskofbaddiagnosis.
Whatwouldbeyouradvicetobuddingentrepreneurs whoaspiretoventureintothehealthcarespace?
TheHealthcaresectorisnoteasyifwetalkaboutafast salesprocessandgeneratingincome.Itwouldbebestto havemoretimeandmoneywhileventuringintothe healthcareindustry.Buildingrelationsandtrusttaketime. Butifyouknowthatproductcouldhelptosavelives-that isahugemotivation!
HowdoyouenvisionscalingCancerCenter.AI's operationsin2022andbeyond?
Wewouldliketoscaleoursalesthroughexisting partners/distributors/producersinoncology Wearelooking forpartnersineverycountry.Atthesametime,weare lookingforaninvestorwhowillhelpustoscaleour organization'sreachtogreaterheights.
Technologyhasundoubtedlybeenaboonduringthe globalcrisiscausedbythepandemic.The coronavirusacceleratedtheadoptionofdigital technology,transformingthehealthcareindustry.Industry playerswereeagertoadopttechnologicalsolutionsto maintainacompetitiveedgeandsurvivethechallenging times.Thediagnosticsareaexplicitlywassufficiently instanttogothroughcomputerizedchangeandisarisingto beacriticalpartofthemedicalservicesindustry.
Thediagnosticprocessinvolvesawiderangeof technologiesandtools,buthealthinformationtechnology (healthIT)toolsaretheprimaryfocusofthischapter Electronichealthrecords(EHRs),clinicaldecisionsupport,
patientengagementtools,computerizedproviderorder entry,laboratoryandmedicalimaginginformationsystems, healthinformationexchanges,andmedicaldevicesareall includedinthecomprehensivehealthinformation technology(HIT)category.
Let'shavealookatthemandlearnmoreaboutthem!
WearableTechnologies
mHealthapplicationsandwearabletechnologiesare reshapinghowpatientsandmedicalprofessionalsreceive healthcare,andtheymayalsoimpactthediagnostic procedure.Patientsandcliniciansalikenowhaveaccessto awiderangeofmHealthapplicationsthankstotherecent explosioninmHealthapplications.Drugreferenceguides,
medicalcalculators,clinicalpracticeguidelines,textbooks, literaturesearchportals,andotherdecisionsupporttools areamongthemanymHealthapplicationsdesignedtoaid cliniciansatthepointofcare.
Althoughtheresearcherswhocarriedoutthestudynoted thattheevidencewaslimited,asystematicreviewrevealed anincreaseintheappropriatenessofdiagnosticand treatmentdecisionswhenmobiledeviceswereutilizedfor clinicaldecisionsupport;asaresult,additionalresearch willberequiredtoreliablyconcludewhetherandhowthese mobiledevicestoaid,whenandhowtheyshouldbeused.
Withoutusable,functionalhealthITsystems,itis impossibletorealizethepotentialbenefitsofhealthITfor improvingdiagnosis.Theterm"usability"indicatesthe "Extentofaproducttobeusedbyspecifieduserstoachieve specifiedgoalswitheffectiveness,efficiencyand satisfactioninaspecifiedcontextofuse."
Thehuman-centereddesignapproachseekstobalancethe requirementsofthecomputerandsoftwaretechnical systemsandthoseofthelargersociotechnicalsystems.
SomehealthITvendorshaveimplementedhuman-centered designprinciples,butthisisnotawidespreadpractice. Additionally,usabilityissuesmaynotbecomeapparent untilthesystemhasbeenimplementedorusedextensively. Asaresult,itiscriticaltoenhancehealthITdesign, implementation,andusecontinuously
UtilizingthevastamountsofpatientdatainhealthIT databases,healthITcanalsobeusedtomeasurediagnostic errors.Forinstance,itispossibletodevelopalgorithmsthat periodicallyscanelectronichealthrecords(EHRs)for diagnosticerrorsorclinicalscenariosthatmightindicate thatadiagnosticerrorhasoccurred.Patientswithnewly diagnosedpulmonaryembolismwhowereseenbya clinicianinanoutpatientoremergencydepartmenttwo weeksbeforediagnosiswithsymptomsthatmayhave
indicatedpulmonaryembolismareanexampleofthe former
Commonplatformsformeasuringdiagnosticerrorswill enablecomparisonsofdiagnosticerrorratesacross organizationsandsettingsforhealthITsystemsutilizedby multiplehealthcareorganizationsoracrossvarious locations(inpatientandoutpatient).Thiscommitteehas madeanimportantrecommendationtoimprovethe identificationofdiagnosticerrors.HealthITvendorsshould makeiteasierfororganizationstofigureouttheratesof diagnosticerrors,especiallythosethatarecommonand havesevereconsequencesforpatients,bydevelopingtools.
CommunicationBreakdownsconstituteasignificantcause ofadverseevents,includingdiagnosticerrors,andthe timelyandefficientexchangeofinformationbetween healthcareprofessionalsandpatientsisessentialto improvingdiagnosis.
HealthIThasthepotentialtocutdownonbreakdownsin intra-andinterpersonalcommunication,aswellasin communicationbetweenpatientsandhealthcare professionalsandtheexchangeofinformation(suchasthe reportingoftestresults).HealthITcanalsohelpwiththe trackingoftestresultsandfollow-up.EHRs,forinstance, canhelpwithcarecoordinationifthey"automaticallytrack referralsandconsultationsaswellasensurethatthe referringphysicianiseasilyabletofollowthepatient's progress/activitythroughoutthecontinuumofcare," accordingtotheAmericanMedicalAssociation(2014).
Theremarkableascentinutilizinginnovationisvitaltothe well-beingarea'sendeavorstodevelopdifferentclient experiencesandbackclinicalchoices.Ithasturnedintoa spineforproceedingwithdevelopment.Digitaldiagnostics willrequireanindustry-wideeffortfromstakeholdersto translateinnovationintoimpact,validationofthesetools, andanewregulatoryapproachtogaintractionand acceptance.
-ShreyasiShelke
Cancerisanailmentthataffectsthesocialfabricof millionsoffamilies,asitseemstohavereached epidemicproportionsoverrecentyears.
Understandably,the'C'-wordcausesmorefearandanxiety thanmostotherailmentstoday,oftendampeningspiritsand dashinghope.Itisadiseasethathasdominatedmuchofthe healthcareeffortsofthe21stcentury.
Onthebrighterside,medicalsolutionsprovidersare fightingtoothandnail,drivingapositivechange,tocounter thisseriouschallengeandovercomeitsadversities.Oneof thekeychallengesinthefightagainstcancerisimproving theabilitytodetectcanceratitsearlieststageswhen patientshavethebestchanceforsurvival.Thereisan immediateneedfordiagnosinganddetectingthe malignancywhenitismoretreatable,andoutcomesare better
RecognizingthisveryneedforearlydetectionImagion BiosystemsLtdisattemptingtobecomealeadingplayerin thehealthcarespace.Withamultidisciplinaryteamanda missiontomakecancermoredetectable,thecompanyis implementingadvancedtechnologytodetectcancerwith betterspecificityandsensitivitythanconventionalimaging technologies.
UndertheproficientleadershipofRobertProulx,CEO, ImagionBiosystemscombinemoleculartargetingwith nanotechnologyandenablesadvancementsinimage analysisthroughmachinelearningandAI—thecompany aimstodetectcanceratitsearlieststagesnon-invasively withoutusingradiation.
InthefollowinginterviewwithInsightsCare,Robert Proulxshedslightonthecompany'sjourneyshowcasing thecurrentindustryscenario,andhisopinionsonthe company'sfuture.
Belowaretheinterviewhighlights:
PleasebriefouraudienceaboutImagionBiosystems,its USPs,andhowitiscurrentlypositionedasareliable firminthehealthcaresector.
ImagionBiosystemsisdevelopingimproveddiagnostic imagingandtherapeuticproductsbasedonourproprietary magneticnanoparticles.Ournanoparticletechnologyuses biosafematerialstonon-invasivelydetectortreatdiseased tissues,likecancer,whileavoidingtheuseofradiationor radiotracers.Byfocusingontheuseofmagnetic nanoparticleswebelievewecandeliverimproved diagnosticimagingmethodsthatworkwithinexisting clinicalcareworkflowandarebetterforthepatient.
Shedsomelightonyourofferingsandhowtheyimpact theindustryandyourclients.
Today,globally,wespendover$100Bannuallytodiagnose cancers,butwestilldon'tcatchthemearlyoftenenough. Imagingtechnologiesprovidegoodanatomicalimagesbut arenotcapableofdifferentiatingbenignfrommalignant lesionsandoftenrequiretheuseofradioactivity
Certaincancerslikepancreaticorovariancanceraretoo oftendetectedwaytoolatebecausetheyareasymptomatic, andcurrentimagingmethodsarenotwellsuitedfor identifyingthesetumors.Inothercases,likeprostate cancer,wehavescreeningtoolsbutwithhighfalsenegative andfalsepositivereadingsresultinginmisseddiagnoses andunnecessarybiopsies.
Ourfirstdiagnosticimagingproductaimstoimprovethe abilitytoidentifymetastaticbreastcancerbynoninvasivelydetectingifthetumorhasspreadtothelymph nodes.Todaythestandardofcarefornodalstagingisa biopsyprocedure,withapproximatelyhalfofallpatients havinganegativetest,meaningtheyhadtohaveabiopsyto findoutnothingwasthere.
Our goal would be to have multiple imaging products in our pipeline advancing into clinical studies and have the organizational infrastructure to support larger studies and early commercial production.
Bob Proulx CEO Imagion BiosystemsCEO Bob Proulx has more than 30 years of experience in the development and commercializa on of novel life science tools and medical device/diagnos c products. Having joined the company in 2015, Bob led the restructuring and refinancing of the company to create Imagion Biosystems and undertake an IPO on the Australian Securi es Exchange. Under his leadership, the company is now a clinical-stage company with mul ple products in the R&D pipeline.
Exemplary Exper se:
I think the fact that the FDA designated our MagSense® HER2 Breast Cancer product as a Breakthrough Device speaks volumes. The Breakthrough Device program is reserved for those medical device technologies that are considered to "provide for more effec ve treatment or diagnosis of life-threatening or irreversibly debilita ng human disease or condi ons" and either address an unmet need or offer a significant advantage over exis ng products.
The recogni on by the FDA of the poten al for our MagSense® technology in breast cancer care is very gra fying. Another example comes from the MD Anderson Cancer Center, the world's leading cancer research and treatment ins tu on. Early on, we established a scien fic collabora on with the Department of Imaging Physics at MD Anderson, and along the way, the ins tu on converted a por on of our sponsored research funding into shares in the company. They have con nued to hold those shares, and we consider having them as a shareholder a privilege.
UsingourMagSense®targetednanoparticlescouldreduce theneedforbiopsyproceduresandsavemanypatientsfrom havingtohavelymphnodalbiopsiesandtheconcomitant painandmorbidityassociatedwithnodallymphsurgeries. ThisproducthasbeendesignatedbytheU.S.FDAasa breakthroughdevicebecauseofitspotentialtochange patientcareinthenodalstagingofbreastcancer.
Beinganexperiencedleader,shareyouropiniononhow theadoptionofmoderntechnologiesandplatformshas impactedthediagnosticsspaceandhowisyour companyridingthetechnologywave?
Firstly,weshouldrecognizethatthehealthcareindustryis generallyconservativeinitsadoptionofnewtechnologies. Healthcarepractitionersandpayersarecautiousabout changingexistingpracticesandstandardsofcare,soany newtechnologywilltaketimetobeadopted.Butrecent advancesintwoareasmaybeofinteresttoImagion's efforts.
Wethinktherecentadvancesinblood-basedtestingfor circulatingtumorcellsandnucleicacidsbodewellfor earlierdetectionofpatientswhomaybedevelopingcancer Earlywarningsignsinthebloodwouldbeagood indicationthatanImagionimagingtestcouldhelpidentify ifthespecificcancerofconcernispresent.
Combinedwithadvancesbeingmadeinimageanalysis throughmachinelearningandAI,wehopethatwecan makecancerdetectableatitsearlieststageswhentheyare moretreatable,andoutcomesarebetter
Whatwouldbeyouradvicetobuddingentrepreneurs whoaspiretoventureintothehealthcarespace?
Itisaverygratifyingareatoworkin.Itisverymotivating andrewardingtoknowthatwhatyouareworkingoncould impactpatients'lives.Butitisalsoahardindustrytowork inandisheavilyregulated.UnlikeFinTechorothertech
sectors,theregulatoryoversightinthemedicalindustryis pervasive.
Additionally,bettertechnology,byitself,maynevermakeit tothemarket,soyoureallymustdoyourhomework. Identifyingunmetmedicalneedsandthenidentifyinghow youaregoingtosolvethatprobleminacommercially scalableandmarket-acceptablewayiskey,andyoumustbe initforthelonghaul.
Howdoyouenvisionscalingyourorganization's operationsandofferingsin2022andbeyond?
Weareanticipatinggrowingtheorganizationtopreparefor thenextphaseofdevelopment.Atthebeginningof2022, wemovedintoanewfacilitythatgaveusexpandedR&D capabilitiesandincreasednanoparticlemanufacturing capacity.Ourgoalwouldbetohavemultipleimaging productsinourpipelineadvancingintoclinicalstudiesand havetheorganizationalinfrastructuretosupportlarger studiesandearlycommercialproduction.
