REDWOOD CITY, Calif., May 24, 2017 /PRNewswire/ -- Guardant Health announced that the Guardant360® assay has been approved by New York State's Clinical Laboratory Evaluation Program (CLEP). The Guardant360 assay is now the first and only comprehensive liquid biopsy permitted by the New York State CLEP, one of the most demanding laboratory certification programs in the country.
"This is an important moment for Guardant Health and for the oncologists and patients we serve," said Guardant Health Co-Founder and President AmirAli Talasaz. "Not only does this allow us to offer the Guardant360 assay in New York, it demonstrates that our lab has met the uniquely high accuracy and reliability standards of New York's laboratory evaluation program."
The Guardant360 assay is the most widely ordered comprehensive liquid biopsy. It was introduced in 2014 and has since been ordered more than 40,000 times by more than 3,500 oncologists. With this approval, the Guardant360 assay can now be offered in all 50 states. The Guardant360 assay can detect single nucleotide variants, insertion and deletion events, copy number amplifications, and fusions in a panel of cancer related genes.
The New York approval follows the posting of a draft local coverage determination by Palmetto GBA that, when finalized and implemented, would cover the Guardant360 assay for certain advanced lung cancer patients on Medicare. Additionally, the test is now supported by more than 25 peer-reviewed publications that address its analytical validity, clinical validity, or clinical utility.
About Guardant Health
Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $500 million from leading venture capital firms. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially available. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc.
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SOURCE Guardant Health