Guardant Health’s Shield Blood Test for Colorectal Cancer Receives FDA Approval
Guardant Health, a leading precision oncology company, announced that its blood test designed to detect colorectal cancer has received approval from the US Food and Drug Administration (FDA). This news has sent the company’s shares soaring by 16% in premarket trading on Monday.
The test, known as Shield, has been available in the US as a laboratory-developed test (LDT) since 2022, with a self-pay price of $895. However, with the FDA approval, Shield is now one step closer to becoming the first blood test for colorectal cancer screening that is eligible for Medicare insurance coverage for older adults.
Blood-based tests like Shield offer a more convenient alternative to feces-based tests, such as Exact Sciences’ Cologuard, for cancer screening. The FDA’s decision to approve Shield is expected to help target more than 50 million people who remain unscreened for colorectal cancer.
According to FDA documents, a study showed that Guardant’s Shield test detected 83% of colorectal cancers, while Exact Sciences’ Cologuard had a sensitivity rate of 92.3%. Despite this, colonoscopy remains the gold standard test for colorectal cancer.
Colorectal cancer affects about 150,000 patients in the US annually and is the second-leading cause of cancer fatalities in the country, with over 50,000 deaths each year. With the approval of Shield, there is hope that more individuals will have access to early detection and treatment, potentially saving lives in the process.