FDA Approves Guardant Health’s Blood Test for Colon Cancer Screening
Company’s Shares Rise 16% After Announcement
Guardant Health recently announced that its blood test, Shield, has received approval from the US Food and Drug Administration (FDA) for detecting colorectal cancer (CRC). This approval has sent the company’s shares up 16% in premarket trading on Monday.
Test Availability and Pricing
The Shield test has been available in the US as a laboratory-developed test (LDT) since 2022 and can be purchased for a self-pay price of $895. However, the company did not provide the pricing for the FDA-approved version of the test. Under certain Medicare plans, patients may not have to bear any out-of-pocket costs for the test.
Importance of Blood-Based Tests
Blood-based tests are more convenient than feces-based tests, such as Exact Sciences’ Cologuard, for cancer screening. These tests are particularly important for targeting the estimated 50 million people who remain unscreened, according to Leerink Partners analyst Puneet Souda.
Compared 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, compared to Exact Sciences’ stool test Cologuard, which had a 92.3% sensitivity rate.
Importance of Colon Cancer Screening
Colonoscopy is considered the gold standard test for CRC. Colorectal cancer occurs in about 150,000 patients in the US annually and is the second-leading cause of cancer fatalities in the country, with more than 50,000 deaths each year, according to the FDA.
Conclusion
The FDA’s approval of Shield is a significant step towards making CRC screening more accessible and convenient for patients. With the ability to detect 83% of colorectal cancers, Shield has the potential to save thousands of lives each year.
Frequently Asked Questions
Q: What is Shield, and what does it do?
A: Shield is a blood test that detects colorectal cancer. It uses a proprietary platform to identify biomarkers in the blood that indicate the presence of cancer.
Q: How does Shield compare to other tests?
A: Shield detected 83% of colorectal cancers in a study, compared to Exact Sciences’ stool test Cologuard, which had a 92.3% sensitivity rate.
Q: Will Shield be covered by Medicare?
A: If Shield is used under certain Medicare plans, patients may not have to bear any out-of-pocket costs for the test.
