New Laws: Do-It-Yourself Kits Bring Lab Testing to the Home

Health care in the 21st century is moving toward consumerization of medicine, patient empowerment and increased price awareness resulting from higher out-of-pocket medical expenditures. The growth of at-home testing products is one key manifestation of these trends in the clinical laboratories sector.

The Pros & Cons of At-Home Testing
It's hardly surprising that the number of companies offering at-home testing products continues to proliferate. At-home testing offers significant advantages to consumers, including not just convenience but privacy, which is a major consideration for sensitive testing like sexually transmitted diseases (STDs) assays. And in an era of shrinking insurance coverage, at-home tests make diagnostics accessible to the uninsured. Patient-initiated testing is entirely outof- pocket (although health savings accounts can be used to pay for some tests.)

But at-home testing is also unproven. In addition to being a waste of treatment resources, some health care professionals are concerned that at-home testing may generate false results, especially when it's self-initiated. The concern is that patients may rely on these results to make vital treatment decisions like adjusting medication doses without clinician oversight.

Types of At-Home Testing Products
At-home products come in two basic forms:

• Mail-in tests in which patients collect their own samples (blood, mouth swab, urine or stool) and mail them to a lab for processing; and

• Instant tests in which sample collection and testing are performed at the patients' home with results available in minutes.

Overview of the At-Home Testing Market
Here's a quick profile of key companies offering products that are currently or soon to be commercially available in each product type space.

Mail-In Testing Providers
Notable providers of at-home sample collection and mail-in testing products include:

• MyLabBox (Los Angeles, CA), which offers a nationwide home-based STD testing service that includes panels consisting of 4, 8 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.

• Everlywell (Austin, TX) which in addition to STD panels offers routine lab tests such as cholesterol and HbA1c, as well as and niche offerings like testosterone, thyroid and heavy metals testing.

• Exact Sciences (Madison, WI), which offers Cologuard, the first and only FDA-approved stool DNA, noninvasive screening for colorectal cancer. The test assesses for 11 biomarkers, including 7 DNA mutation markers, 2 DNA methylation markers, one hemoglobin marker and Beta actin. But Cologuard is different from most other at-home testing products in 2 important ways: first, it's available by prescription only; it's also more expensive than many at-home tests, listing at $649 (although some insurance carriers cover some or all of the cost).

Providers of Instant Result Tests
Some of the notable providers of at-home tests that generate instant results include:

• Scanadu (Sunnyvale, CA), whose heavily hyped at-home consumer diagnostics products have yet to make it to the commercial market, including Scanadu Urine, a disposable paddle that consumers dip into a urine sample and use the Scanadu app and camera on their smartphone to read and analyze the results a minute later.

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

• Medical Electronics Systems (Los Angeles, CA) which 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.

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.