Guardant Health Reports the Submission of Premarket Approval Application to the US FDA for Shield Blood Test to Detect Colorectal Cancer
- The company has submitted the premarket approval application to the US FDA for the Shield blood test. The submission was based on the (ECLIPSE) study evaluating the performance of Shield blood test over screening colonoscopy in ~20,000 avg.-risk adults aged 45 & 84yrs. at 200+ clinical trial sites in rural & urban communities across 34 states
- Acc. to preliminary results, the Shield test had a sensitivity of 83% & a specificity of 90% for the detection of colorectal cancer. The test also demonstrated 13% sensitivity in detecting advanced adenomas
- The test identifies specific DNA characteristics that may indicate the presence of cancer & is commercially available only on prescription through healthcare providers for eligible individuals
Ref: Guardant Health | Image: Guardant Health
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