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Guardant Health ECLIPSE Study Data Demonstrating Efficacy of Shield Blood-based Test for Colorectal Cancer Screening to be Published in The New England Journal of Medicine
Study shows blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% Results pave the way for first potential
About this update from Guardant Health, Inc.
[{"type":"text","content":"\n\nStudy shows blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90%\n\n\n\nResults pave the way for first potential FDA-approved blood test for colorectal cancer screening to meet requirements for Medicare coverage\n\n\n\n PALO ALTO, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that results from the ECLIPSE study showing the effectiveness of its ShieldTM blood test for detecting colorectal cancer (CRC) in average-risk adults will be published in the March 14 issue of The New England Journal of Medicine.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240313547689/en/Shield (TM) from Guardant Health is a blood test for colorectal cancer screening for adults age 45-84 who are at average risk. (Photo: Business Wire)\n“Over 50 million eligible Americans do not get recommended screenings for colorectal cancer, partly because current screening methods are inconvenient or unpleasant,” said AmirAli Talasaz, Guardant Health co-CEO. “We believe the publication of the ECLIPSE study in The New England Journal of Medicine, one of the world’s leading medical journals, is an endorsement of the quality of our clinical data and the potential value of the Shield test. We are confident that offering an accurate blood test has the potential to significantly reduce preventable colorectal cancer deaths.”\n\n\nOne of the largest studies of its kind, ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode) is a 20,000+-patient registrational study to evaluate the performance of Shield compared to a screening colonoscopy. The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA).\n\n\nHighlights of the study results to be published in The New England Journal of Medicine* show that Shield demonstrated:\n\n\n\n83% sensitivity in detecting individuals with CRC\n\n\n\n88% sensitivity in detecting pathology-confirmed Stages I-III\n\n\n\nSensitivity by stage of:\n\n\n65% for pathology-confirmed Stage I; 55% for clinical Stage I\n\n\n\n100% for Stage II\n\n\n\n100% for Stage III\n\n\n\n100% for Stage IV\n\n\n\n\n\n\nThese results are on par with the performance of other gu...