On Monday, the FDA approved Guardant Health Inc.'s (NASDAQ:GH) Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease.
The company says it is the first blood test approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield like all other non-invasive methods recommended in screening guidelines.
Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.
Colorectal cancer is the second-leading cause of cancer-related death in the U.S., even though it is highly treatable if caught early.
The American Cancer Society estimates that more than 150,000 people will be diagnosed with CRC in 2024, and the disease will be responsible for more than 53,000 deaths.
When colon cancer is found at an early stage before it has spread, the five-year relative survival rate is 91%. If the cancer has spread to distant body parts, the five-year relative survival rate is 14%.
The FDA decision follows a recommendation for approval by an Advisory Committee panel in May 2024.
The approval was based on the results of ECLIPSE, a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults.
Results from the study, published in the March 14, 2024, issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for detecting CRC, with 90% specificity for advanced neoplasia. This performance is within the range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.
William Blair notes the bullish sentiment should be tempered for now. The product label contains several barriers to commercialization, including:
- A precaution statement on the first page highlights limited detection of Stage I colorectal cancer and precancerous lesions.
- A limitation is advising providers to discuss the most appropriate screening test with patients based on their medical history and individual circumstances.
- Detailed information to assist in shared decision-making with patients, including a lengthy statement on the test's limitations.
Overall, these limitations may hinder the test's adoption in the already compliant screening population.
The analyst maintains the Outperform rating for Guardant Health.
Guardant Health's Shield blood test competes with Exact Sciences Inc's (NASDAQ:EXAS) Cologuard, a stool DNA-based colorectal cancer screening test for average-risk individuals 45 or older.
Price Action: GH stock is up 5.42% at $34.79 at last check Monday.
Image by PDPics from Pixabay
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