Guardant Health Gets FDA Nod on Colorectal Cancer Blood Test

Guardant Health (GH) connected Monday said that its Shield colorectal cancer-screening humor trial has received support from nan U.S. Food and Drug Administration (FDA), sending shares higher.

Shield is nan first humor trial that nan FDA has approved arsenic a superior screening action for colorectal crab and nan first that meets Medicare sum capacity requirements, nan institution said. The trial is for adults property 45 and older who transportation an mean risk. 

FDA Approval Is 'Significant Victory'

"The FDA support of nan Shield trial is simply a important triumph for patients and an important milestone successful Guardant Health’s ngo to conquer crab pinch data," Co-Chief Executive Officer (CEO) AmirAli Talasaz said. "Shield tin thief amended colorectal crab screening rates truthful we tin observe much cancers astatine an early stage, erstwhile they are treatable."

In a study, nan Shield trial showed 83% sensitivity successful detecting colorectal cancer, including 90% specificity for precocious neoplasia, nan institution said.

Shares of Guardant Health gained 3% to $34.00 arsenic of 2:15 p.m. ET Monday and are up 25% this year.