With FDA Clearance, Guardant’s Blood-Based Cancer Test is One Step Closer to Medicare Coverage

Guardant Health announced that its blood test for detecting cancer in the colon or rectum has received approval from the U.S. Food and Drug Administration (FDA). This approval brings the test closer to being covered by Medicare. Following the announcement, Guardant Health’s shares rose by 3.4% to $34.13. The test is now indicated for asymptomatic average-risk adults aged 45 years and older.

While colonoscopies are considered the most effective test for colorectal cancer, screening rates remain low due to perceived inconvenience and other barriers. “Many people, for different reasons, are not undergoing the procedure, and in the United States, we do not have the capacity to screen many more people through colonoscopy,” said Guardant CEO AmirAli Talasaz.

Guardant’s test, called Shield, has been available in the U.S. for laboratory use at a self-pay fee of $895 but is not currently reimbursable by Medicare. Talasaz believes Shield is ready for commercial use and will qualify for Medicare coverage once it meets the regulatory requirements. However, Guardant has not disclosed the self-pay price for the FDA-approved version of Shield.

Blood-based tests, such as Shield, offer more convenience than feces-based tests, such as Exact Sciences’ Cologuard, for cancer screening. According to documents submitted to the FDA, one trial demonstrated that Shield detected 83% of colorectal cancers. In comparison, Cologuard has a sensitivity rate of 92.3% for colorectal cancer screening.

Colorectal cancer affects approximately 150,000 patients in the United States each year and is the second leading cause of cancer-related deaths, following lung cancer. The new focus for Guardant is the commercialization of Shield, which is expected to be a long and costly process in primary care, according to William Blair’s Andrew Brackmann.