Precision oncology company Guardant Health Inc (Nasdaq: GH) announced on Monday that it has received FDA approval for its Shield blood test as a primary screening option for colorectal cancer (CRC) in adults aged 45 and older at average risk. Shield is the first blood test to achieve this status and meet Medicare coverage requirements.

Colorectal cancer, the second-leading cause of cancer-related deaths in the US, is highly treatable if detected early. The American Cancer Society estimates over 150,000 new CRC cases and more than 53,000 deaths in 2024. Early detection is critical, with a 91% five-year relative survival rate for early-stage detection compared to 14% for distant spread.

Current CRC screening rates in the US are approximately 59%, below the National Colorectal Cancer Roundtable's goal of 80%. Over 50 million eligible Americans skip CRC screening, often finding traditional methods like colonoscopy or stool-based tests invasive or unpleasant.

Shield offers a convenient alternative with over 90% adherence since its commercial introduction in May 2022. Unlike colonoscopies or stool tests, Shield requires only a simple blood draw during routine office visits, avoiding special preparation and discomfort.

FDA approval followed a positive Advisory Committee panel recommendation in May 2024, based on the ECLIPSE study involving over 20,000 patients. Published in The New England Journal of Medicine on 14 March 2024, the study demonstrated Shield's 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia, aligning with other non-invasive screening methods.

Guardant Health was founded in 2012, focuses on transforming patient care and accelerating cancer therapy development through advanced blood and tissue tests, real-world data and AI analytics. Shield is available by prescription and is expected to gain broader commercial insurance coverage following future guideline inclusions by the American Cancer Society and the US Preventive Services Task Force.