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 澳洲幸运5开奖号码历史查询:U.S. Food a෴nd Drug Administration (FDA), sending shares higher.
Shield is the first blood test that the FDA has a🏅pproved 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-澳洲幸运5开奖号码历史查询: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 advance💦d neoplasia, the company said.
Shares of Guardant Health gained ಞ3% to $34.00 as of 2:15 p.m. ET Monday and are up 25% this year.