On December 15, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported positive results from ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode), an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer (CRC) in average-risk adults (Press release, Guardant Health, DEC 15, 2022, View Source [SID1234625307]).

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The test demonstrated 83% sensitivity in detecting individuals with CRC. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. This test also demonstrated 13% sensitivity in detecting advanced adenomas. Based on these study results, Guardant Health plans to complete its premarket approval submission to the U.S. Food and Drug Administration (FDA) in the first quarter of 2023. These results exceed the performance criteria set forth by the Centers for Medicare & Medicaid Services (CMS) for reimbursement.1

In this study, two configurations of a multimodal blood-based screening test were evaluated independently – a cell-free DNA (cfDNA)-only test and a cfDNA test with protein biomarkers. The announced results were derived from the cfDNA-only test, which outperformed the cfDNA test with protein biomarkers.

In addition to the strong clinical performance, blood-based screening has been shown to significantly enhance adherence to CRC screening in a real-world setting. Among the initial 8,000 individuals for whom the test was ordered during a routine visit with their physician, 90% completed the test.2 This is in stark contrast with adherence rates ranging from 43%3 to 66%4 for other non-invasive stool tests. Screening rates remain stagnant and well below the Centers for Disease Control and Prevention’s goal of 80%.5 By providing accurate and convenient screening via a simple blood draw, the company’s blood-based screening test has the potential to significantly improve screening rates and help save lives.

"Over 49 million eligible people in the U.S. remain unscreened for colorectal cancer. We are confident that a high-sensitivity blood test can play a critical role in improving screening adherence rates by offering an accurate and convenient blood test to those reluctant to get screened," said AmirAli Talasaz, Guardant Health co-CEO. "These results demonstrate, for the first time, that a blood test can indeed achieve high-sensitivity detection for colorectal cancer, a disease that was thought to be difficult to detect in blood. And as groundbreaking as these results are, colorectal cancer is just the beginning. Fueled by this success, we will expand this test to detecting many other cancer types, including lung cancer, the leading cause of death from cancer."

"Colorectal cancer is curable if detected early, but rates of adherence to screening remain too low with current screening options. There is a significant unmet need for a convenient, highly accurate screening test to improve these rates," said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School. "The topline results from ECLIPSE are very encouraging and support the use of a blood-based test as a screening option that has the potential to dramatically improve colorectal cancer screening rates by overcoming barriers associated with current testing methods."

Investor Call

Company management will be webcasting a corresponding conference call beginning at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

About ECLIPSE

ECLIPSE 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.

For more informationabout the ECLIPSE study (NCT04136002), visit www.clinicaltrials.gov. Full study data will be submitted to a peer-reviewed publication.

ECLIPSE diverse study representation

Designed to reflect a diverse population of the U.S., the ECLIPSE study included more than 200 clinical trial sites in rural and urban communities across 34 states. Study data includes 13% Black, 15% Hispanic and 7% Asian American populations. Enrollment among Black Americans was above average for a clinical trial, which is important given the disproportionate impact of CRC on the black community.6

Adherence to CRC screening is particularly poor among medically underserved populations, including those with low income and racial and ethnic minority populations. Only 59% of individuals age 50 and older who are Hispanic and 65% of individuals who are Black/African American are up to date with recommended screenings, compared to 68% of individuals who are white.7

ECLIPSE study locations included community hospitals, private clinics, gastroenterology clinics and academic medical centers. In addition, numerous strategies were implemented to increase representation from underserved communities that have lower CRC screening rates, including mobile phlebotomy, transportation/rideshare assistance and language translation services.