<p><span class="bw-dateline-wrapper"><strong>PALO ALTO</strong> &#8212; </span>Guardant Health, a precision oncology company, announced that Palmetto GBA, a Medicare administrative contractor that administers the Molecular Diagnostics Services program (MolDX), granted coverage for the Guardant Reveal test to monitor for disease recurrence in patients with colorectal cancer (CRC) following curative intent therapy. Guardant Reveal, which runs on Guardant’s Smart Liquid Biopsy platform, is a blood test that uses epigenomic (methylation) analysis to detect circulating tumor DNA (ctDNA), a marker of minimal residual disease (MRD), to predict cancer recurrence, helping to guide clinical decisions after surgery or chemotherapy.</p>
<p>As a result of this decision, the Guardant Reveal test is now covered for use in the CRC surveillance setting after curative intent treatment. This represents an expansion from the prior Medicare coverage of Guardant Reveal testing for CRC in the early post-surgical setting only.</p>
<p>Shares in Guardant Health soared 14% on the news mid-Tuesday.</p>
<p>“Utilizing ctDNA testing in the surveillance setting alongside standard of care monitoring, such as CT scans and CEA testing, has the potential to identify molecular recurrence of colorectal cancer ahead of traditional imaging,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “This important step by Medicare will make this testing more widely available to patients and support oncologists in making more informed therapeutic decisions.”</p>
<p>The tissue-free Guardant Reveal test uses a blood sample, in contrast to tumor-informed approaches to MRD testing, which require a healthcare provider to obtain a physical tissue specimen of the tumor. Of the 18 million total cancer patients in the U.S. who would benefit from MRD testing, less than 3% are being tested today. In addition, more than 12 million cancer patients are over five years out from surgery, making it much more difficult to obtain a tissue specimen, and data suggests more than three million do not have tumor tissue available at all.</p>

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