Benzinga | Feb 16, 2021 08:11AM EST

Guardant Health Launches Guardant Reveal Liquid Biopsy Test For Residual Disease And Recurrence Monitoring In Patients With Early-Stage Colorectal Cancer

Guardant Reveal(tm) is industry's first blood-only test able to detect, with 7-day turnaround time, residual disease after surgery and recurrence months earlier than current standard-of-care methods

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, announced the availability of Guardant Reveal(tm), the first blood-only liquid biopsy test for the detection of residual and recurrent disease from a simple blood draw. The first-of-its-kind commercial test improves the management of early-stage colorectal cancer (CRC) patients by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.1-6

The Guardant Reveal test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. The test accurately reports genomic alterations down to allele frequencies of 0.01 percent, and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis of indeterminate potential. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect early-stage cancers including CRC. Results are obtained from a simple blood draw and returned in as little as 7 days without the need for a tissue biopsy.

"For the more than 1.5 million colorectal cancer survivors today in the U.S.8, the risk of recurrence is a serious one. Colorectal cancer is the second leading cause of cancer death in the U.S. and an estimated 10-30 percent of early-stage patients recur8--so it's vital that oncologists have better tools to manage these patients by quickly identifying those high-risk patients who may benefit from adjuvant therapy after surgery, and by detecting recurrence earlier as part of regular surveillance," said Helmy Eltoukhy, Guardant Health CEO. "At Guardant Health our goal is to help cancer patients across the care continuum, and with the Guardant Reveal test, we are now able to serve an earlier patient group, early-stage colorectal cancer patients, where an unmet medical need exists given the limitations of current tools."

"The use of liquid biopsies in clinical practice represents a new frontier in improving cancer care for patients at all stages of their disease," said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. "It's exciting to see that Guardant Health's liquid biopsy tests not only inform targeted therapies for advanced cancer patients, but can now detect signs of cancer in the blood after curative intent surgeries. With this test, clinicians now have an additional tool to evaluate whether a patient with early-stage colorectal cancer is at high risk for recurrence, helping to inform adjuvant treatment after surgery in certain settings, and to detect microscopic recurrence of cancer months earlier than today's standard of care."

The Guardant Reveal test is Guardant Health's first commercially available liquid biopsy test for clinical use in the management of early-stage cancer. The test will focus first on one indication where the unmet medical need exists, early-stage CRC, with additional cancer types to follow.