News Release

CMS Finalizes New Medicare Coverage Pathway for FDA-Designated Breakthrough Devices

Under the new rule, SOLVD Health’s breakthrough-designated devices will receive national Medicare coverage the day of FDA market authorization.

CARLSBAD, Calif., January 20, 2021 – On January 12, the Centers for Medicare & Medicaid Services (CMS) issued the Medicare Coverage of Innovative Technology (MCIT) final rule, which will provide more than 60 million Medicare beneficiaries with expedited access to the latest medical innovations.

The MCIT rule establishes a new Medicare coverage pathway for FDA-designated breakthrough devices by providing national Medicare coverage immediately upon U.S. Food and Drug Administration (FDA) market authorization and lasts for four years.

SOLVD Health, a privately held company focused on preventing disease by making actionable and contextual health information accessible to everyone, currently holds two Breakthrough Device designations – one for its genetic risk assessment for opioid use disorder (OUD), and one for its non-invasive colon cancer screening test.

“To our knowledge, no other molecular diagnostics company has received more than one Breakthrough Device designation, so having it for both our tests has always been remarkable,” said Keri Donaldson, CEO of SOLVD Health. “This new MCIT rule provides yet another important benefit, which will dramatically accelerate our commercialization path so we can provide these tests to those who need it most sooner.”

Under previous rules, FDA approval of a device was usually followed by a lengthy and expensive process to achieve Medicare coverage. The lag time between FDA approval and Medicare coverage has been referred to as the “valley of death” for innovative products, causing undue burden for innovators and delaying access to potentially lifesaving technologies. The MCIT rule will eliminate this lag time for both Medicare beneficiaries and innovators.

SOLVD Health’s genetic risk assessment for opioid use disorder received Breakthrough Device designation from the FDA in 2018 and has been submitted to the FDA for market authorization. Using a simple cheek swab sample, the test analyzes 15 genetic variants involved in the brain reward pathway to identify patients who may be at increased risk for OUD. Healthcare providers can use this personalized risk information to make more informed decisions about the use of oral opioids for short durations when developing pain management plans for their patients.

SOLVD Health’s non-invasive colorectal cancer screening test received Breakthrough Device designation from the FDA in 2019. The test is designed to detect the earliest warning signs of cancer—precancerous adenomas. Using a swab-collected stool sample, the test detects and analyzes microbial genomics biomarkers which are strongly associated with specific stages of colorectal cancer progression. When adenomas are detected, the patient undergoes a colonoscopy, and the adenomas are removed to prevent cancer from developing.

About SOLVD Health

SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, we are enabling individuals and their providers to make better decisions about their health and the health of their families. We accomplish this by translating complex biological signals into actionable patient data that can point the way to better health. To learn more about us, our solutions, and our career opportunities, visit us at

Media Contact:
Janelle Drumwright;