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Guardant Health submits premarket approval application to the U.S. Food and Drug Administration for Shield™ blood test
PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that it has submitted to the
About this update from Guardant Health, Inc.
[{"type":"text","content":" PALO ALTO, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval (PMA) application for Shield™, Guardant Health’s blood test to screen for colorectal cancer (CRC).\n\nThe submission is comprised of data from the company’s positive ECLIPSE study, an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults. Preliminary results from the study showed that the Shield test achieved 83% sensitivity for the detection of colorectal cancer with specificity of 90%.\n\n“Completing our FDA PMA application for Shield is a significant step forward toward our mission of saving millions of life-years through accessible blood-based cancer screening. We are looking forward to partnering with the agency on bringing this life-saving test to the market,” said AmirAli Talasaz, co-CEO of Guardant Health. “Colorectal cancer is the second leading cause of cancer related death, yet one in three eligible adults are not up to date with screening.1 Patient access to blood-based screening can help overcome barriers to traditional screening modalities, especially in underserved populations.”\n\nThe success of a CRC screening program depends on having tests with acceptable performance, but also on the willingness of the target population to complete the screening test.2 Since the launch of the lab developed version of the Shield test in May 2022, it has shown approximately 90% adherence in a real-world clinical setting, demonstrating the value of blood-based screening to increase adherence to recommended screening protocols.3 In fact, the effective sensitivity of the test, which measures the true impact of a screening test by evaluating adherence and test performance, shows that Shield has the potential to detect more CRCs than traditional modalities.3,4,5,6\n\nAbout the ECLIPSE study\n\nECLIPSE is a prospective registrational study to evaluate the performance of Guardant Health’s blood test in detecting signs of CRC compared to a screening colonoscopy in average-risk adults between the ages of 45 and 84 from across the U.S. The ECLIPSE study included more than 200 clinical trial sites in rural and urban c...