FDA Approval Set to Boost Guardant’s Shield CRC Blood Test Revenues

In July, the U.S. Food and Drug Administration (FDA) approved Guardant Health’s (NASDAQ: GH) blood test, Shield, for colorectal cancer (CRC) screening in adults. Shield is the first blood test to receive FDA approval as a primary screening option for CRC, allowing healthcare providers to offer it alongside other non-invasive methods recommended by screening guidelines. Shield is expected to gain traction due to its convenience compared to traditional CRC screenings, like colonoscopies or stool-based tests, which are invasive and can be uncomfortable.

Previously, Shield was available for patients at an out-of-pocket cost of $895. With FDA approval, it is now more likely that Medicare and private insurers will cover the test, making it more accessible to patients. The test is to be administered every three years, beginning at age 45, which aligns with existing CRC screening guidelines. Following the approval, Visible Alpha’s consensus estimates project Shield’s revenue to grow from $1.2 million last year to $3.3 million in 2024. Consensus revenue estimates show Shield revenues could rise to $18 million by 2025, reaching $297 million by 2028.

Shield is only the second blood test approved for colon cancer screening, following Epigenomics’ (FWB: ECX) Epi proColon, which was approved in 2016. However, Epi proColon has been known to have accuracy issues and is not covered by Medicare or private insurance.