NEW YORK, July 29: The FDA has granted approval for Shield, a new blood test developed by Guardant Health, aimed at early detection of colorectal cancer. Unlike traditional methods, which involve colonoscopies or fecal tests, Shield requires only a simple blood sample. The test will be available within a week, with its price to be announced by Guardant Health.

Shield is designed for individuals aged 45 and older at average risk for colon cancer. It detects early-stage cancers by identifying DNA fragments shed by cancer cells and polyps. While it effectively identifies 87% of early-stage cancers, it has limitations, including a 10% false positive rate and a lower detection rate for large polyps compared to colonoscopies.

Current guidelines recommend colorectal cancer screening starting at age 45, yet up to 50% of eligible individuals do not get screened. Shield aims to address this gap by offering a more accessible testing option, potentially encouraging more people to undergo screening.

The test meets Medicare coverage requirements, with no additional cost for those with Medicare Part B. Out-of-pocket costs for individuals with commercial insurance or Medicare Advantage will vary by plan.

Despite its benefits, the test may still necessitate a follow-up colonoscopy if abnormalities are detected. The introduction of Shield hopes to improve screening rates and ultimately reduce the number of colorectal cancer deaths, which are expected to reach 53,000 in the US this year.