Guardant Health Receives Medicare Approval for Liquid Colon Cancer Test

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