Veracyte (VCYT) Announces Palmetto GBA Posting of Draft LCD for Percepta Bronchial Genomic Classifier

September 15, 2016 4:07 PM EDT

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Veracyte, Inc. (Nasdaq: VCYT) announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has posted a draft local coverage determination (LCD) for the Percepta Bronchial Genomic Classifier. The Palmetto draft LCD posting follows the September 8 posting by Noridian Health Solutions, another participant in the MolDx Program that Palmetto GBA established and administers. The remaining two MolDx Program participating MACs are expected to similarly post the Percepta LCD in the future.

The Percepta classifier is a genomic test designed for use in lung cancer diagnosis. The test is supported by multiple published studies demonstrating its ability to make lung cancer screening and diagnosis more accurate and safe by reducing unnecessary surgeries on suspicious lung nodules found on computed tomography (CT) scans.

"As anticipated, we are moving quickly toward securing draft Percepta LCDs from all four MolDx Program participants," said Bonnie Anderson, president and chief executive officer of Veracyte. "We appreciate Palmetto GBA's vision in creating and administering this program, which establishes transparency in the coverage assessment process, and thereby facilitates patient and physician access to important innovations in the genomic testing field."

Veracyte estimates the U.S. market opportunity for Percepta to be $425 million to $525 million today and expects the market to increase in size as lung cancer screening expands. Approximately 50 percent of the current market comprises patients covered by Medicare.

The Percepta test is run following an inconclusive result from bronchoscopy – a minimally invasive procedure that is commonly used to evaluate suspicious lung nodules and lesions found on CT. Clinical validation data from two prospective, multicenter studies were published in July 2015 in The New England Journal of Medicine and demonstrate that the Percepta test identified patients at low risk of cancer with a high degree of accuracy (negative predictive value of 91 percent). When combined with bronchoscopy, the test also achieved 97 percent combined sensitivity for cancer versus significantly lower sensitivity for bronchoscopy alone. Published clinical utility data suggest that use of the Percepta test could reduce unnecessary surgeries and other invasive procedures by 50 percent.

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