Guardant Health down 7% after reporting results of Shield V2 algorithm

Guardant Health (GH) announced a clinical readout update assessing the performance of the latest colorectal cancer screening algorithm for its Shield blood test. The study met all primary endpoints and the sensitivity of this new screening algorithm for detecting CRC was 84% with 90% specificity. Sensitivity for detection of stage I CRC was 62%. “We are pleased with the performance of the new algorithm in detecting stage I CRCs. Today’s update shows yet again that Shield delivers best-in-class performance,” said AmirAli Talasaz, Guardant Health co-CEO. “We will continue to leverage our first mover advantage, rapidly growing database and innovation engine to push Shield to higher levels of performance over time.” The clinical validation of the algorithm was conducted on an expanded cohort of subjects enrolled in the landmark ECLIPSE study. ECLIPSE is a 20,000+ person registrational study evaluating the performance of Shield for detecting CRC in average-risk adults that was published in The New England Journal of Medicine. Sensitivity for early-stage CRC was 62% for stage I and 100% for stage II. Sensitivity was 96% for stage III and 100% for stage IV. Sensitivity in detecting advanced adenomas was 13%. Shares of Guardant Health are down 7% to $60.50 in morning trading.