2023-03-10 08:25:20 ET
- Guardant Health ( NASDAQ: GH ) submitted the final module of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Shield, a blood test to screen colorectal cancer (CRC).
- The filing consists of data from a study called ECLIPSE, a 20K patient registrational study evaluating the performance of the blood test for detecting colorectal cancer in average-risk adults.
- Preliminary results showed that test achieved 83% sensitivity for detecting colorectal cancer with specificity of 90%, according to the company.
- "We are looking forward to partnering with the agency on bringing this life-saving test to the market," said Guardant Co-CEO AmirAli Talasaz.
- GH -1.45% to $26.55 premarket March 10
For further details see:
Guardant seeks FDA approval of colorectal cancer detection blood test