Veracyte Receives Final Medicare Coverage Policies for Decipher Bladder

Veracyte, Inc. (Nasdaq: VCYT) today announced that Medicare Administrative Contractors Palmetto GBA, WPS and CGS Administrators, LLC have finalized their coverage policies for Decipher Bladder, a genomic subtyping tool that helps physicians manage treatment decisions for patients with bladder cancer. These local coverage determinations (LCDs) make Decipher Bladder the first genomic test to be covered by Medicare for such patients. Developed through the Medicare MolDX program, the policies will become effective July 18, 2021, and provide a framework for other participating MACs to follow.

Noridian Healthcare Solutions, another Medicare Administrative Contractor, is expected to similarly finalize its draft LCD, which will make Decipher Bladder a covered benefit for more than 62 million Medicare beneficiaries. In the United States, more than 80,000 individuals are diagnosed with bladder cancer annually, approximately 44,000 of which will have the non-metastatic, Stage I-IIIa disease indicated in these policies.

“Physicians treating patients with bladder cancer are faced with complex and potentially life-changing treatment decisions, including whether or not to prescribe neoadjuvant chemotherapy or proceed directly to radical cystectomy," said Tina Nova, Ph.D., Veracyte’s general manager, urologic cancers. “Studies have demonstrated that knowledge of an individual’s bladder-tumor molecular subtypes can help guide these decisions, over and above clinical features alone. The coverage decisions announced today will make it possible for physicians to access this critical genomic information.”

The Decipher Bladder test is supported by multiple peer-reviewed clinical studies demonstrating its ability to identify which patients have a higher risk of upstaging to non-organ confined disease at surgery and which patients may benefit the most from neoadjuvant therapy. The test also can be used to identify neuroendocrine-like and immune-infiltrated subtypes, which may have implications for future therapeutic strategies.

About Decipher Bladder

Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis from transurethral resected bladder tumor specimens. It was developed for bladder cancer patients with muscle-invasive disease who face the question of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy (NAC). The assay results are reported as one of five molecular subtypes (Luminal, Luminal-Infiltrated, Basal, Basal Claudin Low or Neuroendocrine-like), each of which has distinct biological composition, clinical behavior and predicted benefit from NAC.