FDA Approves Blood-Based Colon, Rectal Cancer Test
Guardant Health’s Shield Test Receives FDA Approval
Guardant Health said its blood test to detect a cancer that starts in the colon or rectum got an approval from the US Food and Drug Administration, sending the company’s shares up 16% in premarket trading on Monday.
What is the Shield Test?
The test, known as Shield, has been available in the US as a laboratory-developed test (LDT) since 2022 and is available for a self-pay price of $895.
What is the FDA’s Approval?
LDTs are designed, manufactured and used within a single laboratory, but the FDA’s approval takes Shield a step closer to becoming the first blood test for colorectal cancer (CRC) screening that is eligible for Medicare insurance coverage for older adults.
What Does the FDA’s Approval Mean?
Guardant did not provide the self-pay price of the FDA-approved version of the test. If covered under certain Medicare plans for people age 65 and older, patients usually do not have to bear out-of-pocket cost for such tests.
How Does the Shield Test Work?
Advisers to the FDA voted to approve the blood test in May, with the regulator allowing its use for adults age 45 years and older.
Why is the Shield Test Important?
Blood-based tests are more convenient than feces-based tests, such as Exact Sciences’ Cologuard, for cancer screening.
What Does the Future Hold?
The FDA decision helps Shield test target more than 50 million people who remain unscreened, Leerink Partners analyst Puneet Souda said.
Comparison to Other Tests
Shield’s approval is the second for a blood-based test for CRC screening in the United States after Epigenomics’ Epi proColon, which was approved in 2016 but failed to meet the government’s 74% or more sensitivity criterion for Medicare coverage.
According to the FDA’s documents, a study showed Guardant’s Shield test detected 83% of colorectal cancers. Exact Sciences’ stool test Cologuard had a 92.3% sensitivity rate.
Conclusion
The FDA’s approval of the Shield test is a significant step forward in the fight against colon and rectal cancer. With its convenience and high accuracy, the Shield test has the potential to increase screening rates and save lives.
FAQs
Q: What is the Shield test?
A: The Shield test is a blood-based test that detects a cancer that starts in the colon or rectum.
Q: How does the Shield test work?
A: The Shield test uses a blood sample to detect genetic markers that are associated with colon and rectal cancer.
Q: Is the Shield test covered by Medicare?
A: The FDA-approved version of the Shield test may be eligible for Medicare insurance coverage for older adults.
Q: How does the Shield test compare to other tests?
A: The Shield test has a sensitivity rate of 83%, compared to 92.3% for Exact Sciences’ stool test Cologuard.
Q: What does the future hold for the Shield test?
A: The FDA’s approval of the Shield test is a significant step forward, and the company plans to continue to work with regulatory authorities to make the test available to as many people as possible.
