Testing Trends to Watch for in 2016

The last year saw a continuation of several testing trends including further expansion of molecular testing and reliance on larger panels, rather than single gene testing, in areas like testing for hereditary cancer predisposition. Uptake of next-generation sequencing-based testing also continued in 2015, particularly in the areas of oncology—where more targeted therapeutics were approved—and non-invasive prenatal testing.

Without a doubt, these trends will continue, fostered by completion of more studies generating evidence of clinical utility and cost effectiveness, and greater integration of molecular testing recommendations into professional society's clinical practice guidelines. In addition to technology-driven testing trends, consumer preferences will shape laboratory testing and volumes.

Consumerization Driving Shift in Testing
With patients now responsible for a larger share of their health care bills, including laboratory charges, they are taking a closer look at their testing needs. Laboratories may, over time, see shifts in volumes away from traditional testing settings towards those that cater to convenience and cost, including those offering testing in retail establishments, direct-to-consumer testing, and expanded over-the-counter, point-of-care testing kits.

The trends of patient empowerment and the consumerization of health care converge in the area of direct-to-consumer laboratory testing. Interest in tests is not limited to the more controversial direct-to-consumer genetic testing (now limited to traits, carrier status, or ancestry, and not pharmacogenomics or disease risk), but there is growing interest in more traditional laboratory tests rooted in wellness and prevention.

In 2016, look for further growth of laboratories like Health Check USA, Wellness- FX, and Direct Labs on the traditional testing side. In the direct-to-consumer genetic testing space, 23andMe announced at the January JP Morgan Healthcare Conference (San Francisco; Jan. 11-14) that it will launch additional health reports with U.S. Food and Drug Administration clearance this year. Despite progress from 23andMe, there has not been definitive direction in how the U.S. Food and Drug Administration plans to oversee direct-to-consumer genetic testing. Expect further letters and potential conflict between the agency and some laboratories engaging with consumers without approval (Pathway Genomics, DNA4Life, and DNA-CardioCheck).

Liquid Biopsy
No list of trends to watch for this year would be complete without mention of liquid biopsy testing. While consumer- driven testing may focus on more basic tests, liquid biopsy technology is moving forward toward ever more sensitive detection and towards greater overall growth.

Emerging platforms are enabling capture of rare, circulating cells or cell-free DNA (see Inside the Diagnostics Industry in DTET's January 2016 issue). But, 2015 was a breakthrough year in demonstrating the clinical utility of these tests. In 2016, look for movement towards expanding non-invasive prenatal testing to average-risk markets, clinical adoption of liquid biopsy for multiple applications in oncology monitoring by companies like Guardant Health, Exosome Diagnostics, and Trovagene, and further emergence of the technology in post-organ transplantation surveillance. The year also began with a large announcement that Illumina is spinning off and heavily investing in Grail ($100 million raised), which will develop a pan-cancer screening test. In 2016, look for more companies applying liquid biopsy technology towards development of pan-cancer screening, but commercialization is likely several years away. (See Inside the Diagnostics Industry in this issue to learn about Chronix Biomedical's One Test). Liquid biopsy for oncology monitoring is a much more "mature" application.

Takeaway: Look for signs of a shift away from traditional testing settings, especially for basic laboratory testing, as well as an increase in patient-directed wellness testing. On the advanced technology side, liquid biopsy technology will continue to permeate clinical care in 2016, particularly for oncology and transplantation monitoring.