Inside the Diagnostics Industry: At-Home Testing Options Expanding

There is a proliferation of companies offering at-home testing. In some cases these are mail-in tests where patients collect their own samples (blood, mouth swab, urine, or stool) and mail them into a laboratory for processing. In other cases, though, sample collection and testing is performed at the patients' home with results available in minutes.

These instant tests represent advancements in lateral flow technology (paper strips, much like easy-to-read pregnancy tests), as well as entirely new forms of testing, including portable analyzers intended for at-home use.

At-home testing offers many advantages for the consumer, including convenience, privacy (especially for sensitive tests like for sexually transmitted diseases [STDs]), increased access to care, especially for those without insurance, and reassurance from ongoing monitoring. But, some health care professionals are concerned that at-home testing, especially self-initiated, can result in false results, wasted resources for unneeded or unproven tests, or even worse, adjustments to treatment doses without clinician oversight.

For many analysts, at-home testing is the inevitable evolution of health care reflecting ongoing trends of consumerization of medicine, patient empowerment, and increased price awareness resulting from higher out-of-pocket medical expenditures. (Patient-initiated testing is entirely out-of-pocket, although in some cases health savings accounts can be used to pay for the tests.)

DTET examined some of the more popular at-home offerings currently available, as well as those expected to be commercially available soon. A sampling of at-home tests follows.

At-Home Sample Collection, Mail-In Testing

MyLabBox (Los Angeles, Calif.) offers a nationwide home-based STD testing service. The company says an estimated one-third of Americans may have an STD, but inconvenience, embarrassment, and lack of knowledge may hamper testing efforts. The company offers panels consisting of four, eight, or 14 conditions, including HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, trichomoniasis, mycoplasma genitalium, and human papilloma virus. The panels range from $189 to $399.

MyLAbBox has partnered with Target, Walmart and Amazon to sell its "discreet" mail-in kits online. Samples (vaginal swab, urine, or finger prick) are mailed and testing is performed in CLIA-certified labs. The company says turnaround from order to results for all mail-in kits is estimated to be five to 11 days, including one to three days for customers to receive the kit and two to eight days for processing and posting of the results online. An email notification with a link to a secure portal is sent as soon as the results become available. All customers who test positive using the myLAB Box service are entitled to a complimentary phone consultation with a myLAB Box physician affiliate, although availability of consultation and treatment services varies by the clients' state of residence and symptoms.

Everlywell (Austin, Texas) similarly offers STD panels, but also offers routine laboratory tests (such as cholesterol and HbA1c), as well as more niche offerings, including testosterone, thyroid, and heavy metals testing. The company says it works with a physician network to ensure that each individual's test requisition is authorized by a board-certified physician in the state of residence and that all results are reviewed and released by a physician prior to return to the individual.

The company currently does not offer services in New Jersey, Maryland, New York, or Rhode Island. In all other states kits are ordered online and delivered in two to five days.

Exact Sciences (Madison, Wisconsin) offers Cologuard, the first and only FDA-approved stool DNA, noninvasive screening for colorectal cancer. The test assesses for 11 biomarkers, including seven DNA mutation markers, two DNA methylation markers, one hemoglobin marker, and Beta actin. Unlike the other tests mentioned above, Cologuard is available by prescription only. However, the company can assist individuals find a local doctor offering the test to individuals at routine risk of colorectal cancer. Kits are mailed directly to the individual and test results are returned to the prescribing physician within two weeks of the laboratory receiving a sample. Biomarker analysis provides a single positive or negative reportable result. Cologuard is also more expensive than many at-home tests, listing at $649, although some insurance carriers cover some or all of the cost.

At-home Testing With Instant Results

Pregnancy tests and blood glucose monitoring may be the best known, do-ityourself tests, but innovation is expanding the potential for routine home monitoring for both wellness and chronic conditions.

In an article published earlier this year Consumer Reports medical advisers listed FDA-approved tests worth trying at home (blood glucose, fecal occult-blood tests, HIV, urinary tract infections, yeast infections) and those to avoid as do-ityourself tests (allergy, c-reactive protein, prostate cancer, testosterone, thyroid disease, and vitamin D).

Scanadu's (Sunnyvale, Calif.) much hyped in-home consumer diagnostics for consumers have yet to make it to the commercial market. The company says it is awaiting FDA-approval for its urine test kit. The kit enables individuals to check for several health conditions by measuring markers in a urine sample. Scanadu Urine is a disposable paddle that consumers dip in a urine sample. Results can be read and analyzed using the Scanadu app and the camera on a smartphone. Results are displayed in a minute.

Cor (San Francisco, Calif.) closed their Indiegogo crowdsourcing campaign in May 2016 and is still validating its hardware platform, which translates spectral data into quantitative chemistry insights. The single use Cor Cartridge is pressed anywhere against the user's arm to get a blood sample, using a fine needle that takes a surface-level blood sample, which the company says is completely painless. The cartridge is then placed in the Cor Reader. (Cartridges are available for a $10-per-month subscription.)

The company's patented vibrational spectroscopic technology analyzes the sample, with a report available in the Cor App in minutes. The report indicates overall health trends of key indicators like cholesterol (high-density lipoprotein, low-density lipoprotein, and total cholesterol), fasting blood glucose, inflammation (fibrinogen), and triglycerides. The Cor App gives "actionable insights," including diet and lifestyle recommendations. The company says that since they are only making only general wellness claims, they believe the regulatory timeframe will be "condensed."

Blood Test Before Chemotherapy - Patients undergoing chemotherapy receive a blood test at the treatment center before undergoing treatment. However, it is estimated that one in five are sent home without treatment because of low blood counts. Researchers at Royal Marsden Hospital (United Kingdom) developed Aptus, a handheld blood testing kit to monitor blood counts (hemoglobin and hematocrit) at home from a drop of blood from a finger prick. Results are available in a minute. The miniaturized optical technology is reagentless, meaning the cuvettes have a long shelf life and do not require special storage. A cloud-based communication system enables patient data to be transferred to electronic medical records for review by the clinical team. Not only does the device save patients inconvenience and aggravation, but it reduces chemotherapy cancellations, saving treatment centers money, too. Entia, a UK-based company that is validating and commercializing the technology, says it is likely two years before the device will be commercially available.

Paper-Based Monitoring of Heart Failure - A paper test strip can help doctors and patients with heart failure monitor the condition from home, according to a study published online May 8 in ACS Nano. Such monitoring allows for adjustments in treatment and prevention of emergency room visits. The platform is based on fluorescent lateral flow technology, which the authors say is highly sensitive and can provide simultaneous quantitative analysis for two target antigens associated with heart failure (brain natriuretic peptide [BTP] and suppression of tumorigenicity 2 [ST2]). The platform integrates a smartphone- based reader with the multiplexed fluorescent lateral flow strip (LFS). Colored dots glow on the strip if the antigen is present. The researchers report the platform achieved detection of BNP and ST2 antigens in spiked samples with detection limits of 5 pg/mL and 1 ng/mL, respectively, both of which are of one order lower than their clinical cutoff. The smartphone-based portable reader and analysis app can enable sharing of results with doctors remotely.

Medical Electronics Systems (Los Angeles) has received much attention for its FDA-approved, YO Home Sperm Test, the first home male fertility test kit powered by a smartphone platform and supported by an interactive app experience. The company also manufacturers commercial-grade semen analyzers. The at-home test allows users to view and measure the number of motile (moving) sperm in their sample, which the company says is a key measure of assessing male fertility.

For $49.95, two YO fertility tests are supplied with each kit. The YO Clip (mini-microscope) is placed over the camera of the smartphone, then a YO slide is prepared and inserted into the YO Clip. The smartphone camera records and YO displays an actual video of your sperm, and the YO app "reads" this video and delivers immediate, easy-to-understand and accurate results.

Takeaway: There are an expanding number of options for consumers to conduct at-home testing. The commercial market is growing for tests mailed in to CLIA-certified laboratories and is expected to see a number of new entrants for instant tests capable of providing results at home, as well.