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Guardant Health Reveal Assay Gets Additional Medicare Coverage for CRC Surveillance Testing

NEW YORK – Guardant Health announced Tuesday that its Guardant Reveal liquid biopsy test has received coverage from Medicare administrative contractor Palmetto GBA to monitor colorectal cancer patients after receiving curative intent therapy.

The test was previously covered by Medicare for use with colorectal patients in the early postsurgical setting only and is now covered for use in the surveillance setting, Guardant said in a statement.

The blood-based assay uses epigenomic analysis to detect circulating tumor DNA to predict cancer recurrence.

"Utilizing ctDNA testing in the surveillance setting alongside standard-of-care monitoring, such as CT scans and [carcinoembryonic antigen] testing, has the potential to identify molecular recurrence of colorectal cancer ahead of traditional imaging," Guardant Chairman and co-CEO Helmy Eltoukhy said in a statement. "This important step by Medicare will make this testing more widely available to patients and support oncologists in making more informed therapeutic decisions."