Solvd Health is developing a colorectal neoplasia test that detects precancerous polyps with 90 percent accuracy.
The FDA granted the test Breakthrough Device designation in September 2019, and CMS announced Jan. 12, the test would receive Medicare coverage through a new pathway approved by the FDA.
The Medicare Coverage of Innovative Technology final rule is automatically providing devices with Breakthrough designation Medicare coverage once they receive market authorization.
The swab-collected stool sample test detects microbial genomics biomarkers which are strongly tied to specific stages of colorectal cancer progression. Upon receipt of a positive test, patients must undergo a colonoscopy to confirm and remove the adenomas.
The need for an additional colonoscopy presents a financial burden for some patients, as Medicare will only cover one test annually. It is the same issue other at-home alternatives suffer from. However, the consensus remains to be the best screening test is the one that gets done.