Making sense of the home lab testing market as it stands today, and how the industry can point it in a positive direction for the future.
By Jim Poggi
Home lab testing has been around for many years, since the first glucose monitors were introduced for home monitoring in the early 1970s. They were intended to serve the needs for diagnosed diabetics to help improve glucose levels through frequent monitoring. Many easy-to-use general health screening tests followed, including routine urinalysis for general health. Fecal occult blood tests for colorectal cancer then came along. Later on, a variety of tests for abused drugs joined the portfolio. Pre-COVID there were many over-the-counter home tests for general health and wellness, diabetic monitoring and even screening for abused drugs.
Providing ease of use and an easy to acquire sample, they had one thing in common: they were intended to be used to provide information specific to a single patient as opposed to diagnosing a communicable condition that could be transmitted to others. As a result, while not reporting a result of these tests always reduces data useful to the healthcare system in general and to the patient’s care giver specifically, ramifications of the absence or presence of the data in the patient’s record only influenced the path to care of a specific individual.
Fast forward to the last 18 months and COVID has, once again, changed the landscape dramatically. COVID has created a far broader level of access to home testing and increased public awareness to the value of home tests. At the same time, several different companies have begun offering home sample collection tests for sexually transmitted infections (STIs). There is even at least one test for HIV that can be performed and read at home.
No one can argue that these trends are not valuable to the general public, the healthcare community and those of us who manufacture or distribute these important tests. But, nothing is free and they do come with some costs that balance patient responsibility, privacy and access to data valuable for treatment and epidemiological purposes. In this column, I will explore the advantages of the emerging technology, discuss some of the challenges their deployment creates, and even suggest some ways to take a large leap forward and attempt to fill some of the gaps in data availability that currently exist.
Who are the target patient populations for these home tests?
Three general categories emerged as I researched the market. The first is well known as the “worried well,” which includes folks who test knowing they already have a chronic condition that needs monitoring, and those who willingly take control over their own health and perform some vital signs and routine urinalysis tests at home. Joining these ranks are two new groups which I will take the liberty of naming: The “expected to be detected,” group, subject to home drug tests either voluntarily, perhaps as a preview to pre-employment screening or involuntarily due to the influence of family or friends. They are distinctly different from the worried well. Then there is the “suspected infected” group, which today includes a group who have options for home testing for respiratory or sexually transmitted infection tests.
It is likely that infectious disease tests will continue to migrate to the home environment and will shift some of the burden of deciding whether to initiate a treatment program from the physician office to the home user. In and of itself, this is not a bad thing, as it empowers patients to take ownership of their health and personal habits that influence health outcomes.
But home testing, as it exists today, largely leaves some unanswered questions about result quality, privacy, access to the information and whether and how it makes its way into the patient record and public health data base. Let’s look at some positive developments, and some areas I believe are subject to improvement.
The technology is there
The technology in use today for most home tests has been subject to FDA oversight and CLIA waiver. The process has been rigorous. COVID tests have been launched under Emergency Use Authorization, and while less rigorous than the 510(k) process, these tests have been subjected to internal and FDA review. Overall, I do not believe there is a general quality issue, and test performance in every category is better than in previous years, and continues to improve. It is reasonable to conclude that the products will continue to get easier to use, and that a wider range of new tests will be forthcoming. As an associated issue, standardization is a requirement for tests, especially for chronic conditions, to be comparable across platforms and home testers. All signs point to broader patient access to testing and results appropriate to high quality patient care.
What about the user?
However, quality is also influenced directly by the knowledge and skill of the person performing the tests. The first-time home user faces a learning curve, and help needs to be readily available even for the simplest test procedures. This is one area where manufacturers of home-use tests can and should be able to provide online resources to both the patient, virtual visit practitioners and the clinicians most likely to provide first-line patient care for these clinical conditions. Current technology and resources should be able to easily bridge any issues here. Manufacturers and distributors need to put a training and support strategy in place to assure user confidence and proper results.
What about accessibility, HIPPA compliance and privacy?
This is where things get murky. Home tests decidedly improve accessibility of tests, but inherently do not provide a formal mechanism to communicate the data beyond the user. As an example, in the respiratory testing market, over 1 billion COVID antigen tests have already been provided to home users by the federal government, with the Biden administration pledging an additional 1 billion tests. Assuming the U.S. population at about 330 million, that’s about six tests per person – very impressive access to testing.
So, what about result reporting? The Institute for Health Metrics and Evaluation has estimated that only about 7% of all COVID test results have made it into the public data base. Whether this fact changes the overall treatment picture for COVID or not, it shows a very substantial miss in data completeness. In the early going, most lateral flow COVID antigen tests were sent to patients for use without any accompanying way to
automatically report the data. There have been innovative software solutions that were inspired by the initial interest from companies and the federal government to provide a “vaccinate or test” solution for a healthy workplace. The ones I am familiar with provide an impressive range of options including automating test recognition, video monitoring of the testing process to assure the test is correctly performed, and documented and providing test results to only those designated by the person performing the test at home. In effective use, these tools have the technology to fill some gaps in availability of test data, even while the patient has control over who can see the information.
Solutions of this sort need to be well understood and considered for implementation more broadly across home testing products and platforms. Today, they are more a novelty associated with COVID testing than a broadly used solution to data access, HIPPA compliance and patient privacy.
One additional option to assuring test quality and accessibility is easily available via virtual patient visits, during which the test can be proctored in real time, the patient coached through any questions or issues they have in properly performing the test, and results made available as part of the record of the virtual visit. Understanding the level of resources required to provide this solution on a large scale is a key
consideration. Virtual visits have scaled up substantially since the inception of COVID, so at first blush, this approach seems plausible.
A different challenge to result accessibility involves the increasing number of patient portals used, particularly by older adults with multiple co-morbidities and who may be likely to be less technically proficient. As an example, an elder patient may have their records stored by their primary care practice, local hospital, state department of health as well as associated specialists. It is possible for their information to be housed in four or more separate EMR systems. Typically, the best EMR provider solutions permit the aggregation of the disparate information under general headings (history, test results, etc.) so the full picture is accessible to both the patient and their primary care givers in the primary care giver’s EMR. Of course, this accessibility is compromised by any information that does not find its way into the patient record.
Does diagnosis lead to treatment?
One argument advanced to mitigate the impact of unreported tests is to assume that patients with discomfort and overt symptoms are likely to present themselves for treatment. For symptomatic patients performing at-home tests, the answer is likely to be determined by the particular condition, their assessment of the potential duration and seriousness of the illness, concerns about transmission to others and availability of a cost-effective treatment.
For respiratory conditions, it seems clear to me that there will be a range of patient responses largely based on the severity and duration of their symptoms, their co-morbidities, access to a trusted clinician and whether they believe there is an affordable and effective treatment. I am surmising that socioeconomic factors including general access to healthcare and disposable income will come into play in this decision process.
Drug tests fall more into the category of whether an individual with a positive test result sees a reason to change their behavior and make lifestyle changes. Pre-employment screening and parental or peer pressure are likely factors to influence WHO tests, but I do not perceive a clear-cut answer on who reports the test results based on the history of personal lifestyle choices.
STIs also seem to fall into a grey zone. Syphilis, gonorrhea, chlamydia, and HIV are all reportable diseases, and, as such, a positive result needs to be reported to public health authorities. Today, there are two general types of home tests for STIs: those where the patient receives a sample collection kit and instructions and sends them back to a reference laboratory to be performed, and a more limited range of tests that can be performed and provide a result at home. For the lab tests, the responsibility to report a positive result for a reportable STI resides with the lab. From my research, they typically advertise confidentiality as defined by not informing the patient’s partner(s), insurance carrier or primary care giver. But they are required to report positive test results in conformance with general CDC requirements for STIs as well as regulations that vary from state to state.
In the case of a home test, the responsibility resides with the patient. One home HIV test I know of requires any patient experiencing a positive on the home test to have a second confirmatory test performed by a qualified laboratory. This improves the compliance picture, but is certainly no guarantee of compliance. Treatment decisions are far more likely to motivate result reporting and follow up, especially in the case of HIV. But social considerations will also play a role. Patients may be concerned about negative impact on an intimate relationship, shame by family and peers, as well as potentially exposing some level of information about their sexual practices. These is no simple answer here. How big of an issue could this be? In 2018, there were 26 million STIs reported in the U.S. per the CDC. They report that 1 in 5 Americans have an STI, though most STIs are not reportable. Approximately 92% of all STIs are not reportable and include HPV, herpes, and trichomonas infections. So, this is a significant healthcare consideration, and while it seems obvious that positive results for reportable tests need to be reported, there are any number of reasons why they may not be.
Remaining gaps
What are the remaining gaps to manage the delicate balance between access to home tests, privacy, data accuracy and results being incorporated into the patient record? Let’s take a look.
Result quality
This one is well under control from the technical performance perspective. Current test systems provide simple, easy to use and accurate test results. Their performance and variety of available tests continues to improve. We need to strive to assure that all the educational and training materials needed to make the home user confident and competent are in place. At the same time, manufacturers and distributors should reinforce this message about their mutual commitment to result quality and patient education to the clinical community. It is important that our commitment to result quality be known and understood to assure this market remains viable and positively impacts the overall healthcare system.
Accessibility, HIPPA compliance and privacy
I am going out on a limb here and propose that to the extent possible, the diagnostics community, both manufacturers and distributors, find reasonable ways to assure that results are placed in the patient record in accordance with HIPPA regulations and CDC reporting requirements. In my view, this area is where the gaps are greatest. There are four options I can think of:
Option No. 1: Ignore the situation and hope it goes away. Avoidance never really works and is irresponsible to some extent. Non-runner in my opinion.
Option No. 2: Wait for the government to come up with a solution and work with it. Remember CLIA? How about PAMA? Nope, it is in the best interests of manufacturers and distributors to get ahead of the curve and discuss and develop reasonable solutions. There are ways to do so, some simpler and less expensive than others. This leads us to options 3 and 4.
Option No. 3: Develop a working group of manufacturers and distributors with a common interest in a workable solution and create an “open architecture” solution to data collection, management and reporting across testing systems. Some solutions have already been developed for COVID antigen testing, so it is technically feasible.
Option No. 4: A leading manufacturer or distributor COULD go on their own and develop a unique, proprietary solution they would implement as part of their sustainable customer value proposition. My experience is that without strong patents and intellectual property protection, these proprietary solutions have a relatively short market life. But there is certainly some appeal to being a first mover in implementing a solution of this type.
Not going away
Home testing is here to stay and has several positive benefits regarding providing needed tests to patients and assuring a new and improved level of test access. For this promise to be kept and for the market to remain viable in the long run, new, innovative ways to manage the testing process and result reporting gaps need to be considered, explored and implemented. Interesting times ahead for all of us. The decisions we make will be a factor in shaping the future of this market.