A look at the emerging home testing market

Taking it Home

A look at the emerging home testing market.

With the emergence of the COVID-19 pandemic, most of us have spent more time at home in the past two years

than in previous years. Sheltering-at-home mandates, companies offering employees the flexibility to work from home and good common sense have changed our behavior in many ways, especially in what home means to us. More time at home has changed life in many ways: home sales are up substantially as well as home improvement projects, probably reflective of our desire to improve the environment where we are spending so much time.

Testing and healthcare visit patterns have undergone significant change as well. Virtual visits have grown rapidly, pop-up testing facilities offering either on-site testing or on-site sample collection for testing in a clinical lab have emerged as a significant trend. Unsurprisingly, testing at home either under a physician prescription or by patient direction has become a dominant factor particularly for SARS CoV-2 antigen (COVID-19) detection. Under EUA, there were 17 COVID-19 antigen detection kits available for home use at press time. The U.S. federal government has implemented a program to provide four home use COVID-19 antigen tests per house-

By Jim Poggi

hold. At least 500 million tests are planned for distribution under this program and the first wave of tests has already become available. In addition, the Health Resources and Services Administration (HRSA) of the Department of Health and Human services is providing HRSAsupported healthcare centers and Medicare certified rural health clinics with no cost COVID-19 antigen test kits for patient distribution.

Though the proposed OSHA mandate of “test or vaccinate” stalled out in the courts, some employers are initiating home testing for employees as an element of their workplace safety and health program. Home use tests are popping up everywhere and they are new. Or are they? In this column I plan to look at the emergence of home testing, its current state and to speculate a bit on how it’s likely to evolve over time.

Home under change: smart phone, EMR, cloud data storage and digital results

Changes in technology, even before COVID-19 hit, began to change this

For many years, home testing involved a narrow range of tests, mostly available through the patient’s pharmacy. Home glucose testing and urinalysis dominated the market until the development of CLIA-waived lateral flow tests for pregnancy, which created the next wave of test expansion.

Home then: land line, paper patient records and visually read tests

For many years, home testing involved a narrow range of tests, mostly available through the patient’s pharmacy. Home glucose testing and urinalysis dominated the market until the development of CLIA-waived lateral flow tests for pregnancy, which created the next wave of test expansion. Pregnancy, fertility testing and urinary tract infection tests have become commonplace in the past 30 years. Fast forward and home drug tests for marijuana, amphetamines and several other drugs have entered the market and are widely available. Other than glucose tests that deliver quantitative results, the majority of these assays had a few things in common: they were CLIA waived, used lateral flow technology, qualitative (presence or absence) and used urine as a sample. Results were visually read and only reported into the patient record sporadically through patient: care giver interaction. In the early going, EMR was not available to capture this data. It seemed that new tests would follow this pattern.

pattern. Continuous glucose monitoring systems use a combination of patient sensors coupled with smart phone applications to replace frequent daily finger stick testing with continuous transdermal monitoring of patient’s glucose without a blood sample.

In parallel, the deployment of EMR technology provided a pathway to capture off site testing data for later management and reporting. Smart phone applications and cameras, along with cloud storage of data, meant that data could be collected, documented by photo, transmitted, and stored in EMR or elsewhere with relative ease. Data that previously would be available to only the user and perhaps their care giver could now become part of the patient record.

These technologies set the stage for the revolution we are just beginning to experience surrounding COVID-19, and which I predict will continue to grow and provide a surprising array of new tests and deployment of testing technology unheard of just a few years ago.

Home becoming a connected testing site

Availability of home testing for COVID-19 has posed a dilemma regarding data: How do we report the result, assure its accuracy and transport it into the patient record? IT to the rescue; there are several smartphone applications that record the test process, document the result photographically, time stamp when it was created, report it to the requester and those they give permission to see it (employers and care givers) and even post in into EMR. Fundamentally, this changes everything. Benefits include assurance that test results can be automatically reported, can be assured to be accurate and that results can be presented to the patient and care giver for proper patient care. These are all arguably good things.

Yet, they do come with costs, concerns and questions. What about data privacy and cybersecurity? What about standardizing results of a specific test among different methods? Can they be equivalent? If not, how can they be compared for meaningful data across patients and technologies? What kind of damage can result from a large-scale data breech?

Home becoming a dominant testing site?

Once again, COVID-19 proves that the pressure created by change drives progress. Home testing under EUA for COVID-19 antigen has become the gateway to challenge WHAT we can and should test for at home. At the same time, as saliva samples have proven to be acceptable for COVID antigen tests, they’ve expanded the

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non-invasive sample types available and lead to the question of what else can we properly test using saliva. Forward thinking university and commercial research facilities have now demonstrated that molecular assays can be performed at home using a simple, relatively inexpensive analytical platform coupled with the cell phone to create a RT-LAMP assay for COVID-19. This is not a commercial reality at present, but points to at least one future direction: previously expensive and sophisticated technology CAN be down scaled to provide results at home or other non-laboratory settings.

The home/POL connection

Among the questions that remain to be answered are not only the complex issues related to data collection, management, security and

Availability of home testing for COVID-19 has posed a dilemma regarding data: How do we report the result, assure its accuracy and transport it into the patient record?

ownership, but also how home testing will impact testing in centralized sites, such as hospitals, private reference labs and the POL. Which tests will be available and cleared for use at home? What sort of proficiency tests will be needed? Will home testing be only for the worried well? Will it be accepted by the mainstream clinical community which has been slow to embrace change? Will results from the same test type from disparate technologies be sufficiently similar to co-exist? Once EUA is terminated, will the 510(k) process inhibit or accelerate deployment of testing outside the typical lab environment?

There is tremendous promise in the future for more and better testing to be available when and where needed to initiate or modify a patient treatment program. Nonetheless, there are several issues to be resolved for the pathway to the future of testing to be clear. One thing is certain: we are not going back to the days where the patient was only the recipient of patient testing. Patients are now squarely involved in determining the future state of lab testing. Your voice counts in the direction of future testing. Be informed; be heard.

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