Key Takeaways
- Guardant Health’s Shield blood test for colorectal cancer was approved by the FDA.
- Shield is the first blood test that the FDA has approved as a primary screening option for colorectal cancer, the company said.
- Guardant Health shares rose in intraday trading Monday on the news.
Guardant Health (GH) on Monday said that its Shield colorectal cancer-screening blood test has received approval from the U.S. Food and Drug Administration (FDA), sending shares higher.
Shield is the first blood test that the FDA has approved as a primary screening option for colorectal cancer and the first that meets Medicare coverage performance requirements, the company said. The test is for adults age 45 and older who carry an average risk.
FDA Approval Is ‘Significant Victory’
“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data,” Co-Chief Executive Officer (CEO) AmirAli Talasaz said. “Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable.”
In a study, the Shield test showed 83% sensitivity in detecting colorectal cancer, including 90% specificity for advanced neoplasia, the company said.
Shares of Guardant Health gained 3% to $34.00 as of 2:15 p.m. ET Monday and are up 25% this year.