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Guardant Health Receives New York State Approval for Guardant Reveal MRD Test

This story has been corrected to remove a reference to sensitivity across multiple tumor types.

NEW YORK – Guardant Health said on Thursday that the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) has approved its Guardant Reveal liquid biopsy test for the detection and monitoring of minimal residual disease in patients with early-stage cancer, initially colorectal cancer.

With the approval the company can now perform the test for New York state residents, as well as patients elsewhere in the US under its existing CLIA certification.

Launched this February, the assay is Guardant’s first commercially available product for use in the clinical management of early-stage tumors, focused initially on colorectal cancer with additional cancer types to follow. It relies on the detection of mutational and epigenetic signals in circulating tumor DNA and is intended for use after a patient undergoes cancer removal surgery — to identify individuals with residual disease who may benefit most from adjuvant therapy, and to monitor them for emerging recurrence.

According to Guardant, Reveal has shown 91 percent sensitivity in detecting ctDNA MRD.

The company is involved in several prospective validations of the technology, including the COBRA trial, which is tracking 1,400 Stage II colon cancer patients to evaluate whether using the company's test to guide post-surgery adjuvant treatment decisions offers an improvement over current standard of care, and a second similar study in Stage III patients in collaboration with Stand Up 2 Cancer (SU2C), Massachusetts General Hospital, and the Dana-Farber Cancer Institute.