On April 1, 2021 Guardant Health, Inc. (Nasdaq: GH) announced that the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has approved the Guardant Reveal liquid biopsy test for the detection and monitoring of minimal residual disease (MRD) in patients with early-stage cancer (stage II and III). Guardant Reveal is the first blood-only test able to detect, with 7-day turnaround time, a patient’s status for residual disease, without the need for a tissue biopsy.

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The Guardant Reveal blood test was introduced earlier this year and is Guardant Health’s first commercially available liquid biopsy for clinical use in the management of early-stage cancer. The test is focused first on one indication where the unmet medical need exists, early-stage colorectal cancer (CRC), with additional cancer types to follow. The Guardant Reveal blood test improves the management of CRC 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 test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic and epigenomic alterations. 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. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect residual disease in early-stage cancers including CRC.

"Securing New York State CLEP approval for Guardant Reveal means that oncologists in New York can now use the test to identify high-risk patients with colorectal cancer, our first indication, who may benefit from adjuvant therapy after surgery, and to detect recurrence earlier as part of regular surveillance," said, Helmy Eltoukhy, Guardant Health CEO. "This approval is consistent with our commitment to improving care for all cancer patients by expanding access to our tests by complying with appropriate clinical laboratory regulations."

There are over 1.5 million colorectal cancer survivors today in the U.S. and an estimated 10 percent to 30 percent of early-stage patients recur.8 An unmet medical need exists to offer new tests that can overcome the limitations of current tools.