SOUTH SAN FRANCISCO, California–(BUSINESS WIRE)–Verracyte, Inc. (Nasdaq: VCYT) announced today that Medicare Administrative Contractors Palmetto GBA, WPS and CGS Administrators, LLC have completed their coverage policy for Decipher Bladder, a genomic subtyping tool that helps physicians manage treatment decisions for patients with bladder cancer. These local coverage provisions (LCDs) make Decipher Bladder the first genomic test covered by Medicare for such patients. The policy, developed through the Medicare MolDX program, will take effect July 18, 2021 and provide a framework for other participating MACs to follow.
Noridian Healthcare Solutions, another administrative contractor for Medicare, is expected to similarly finalize its draft LCD, making 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 each year, approximately 44,000 of whom have stage I-IIIa non-metastatic disease identified in this policy.
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“Physicians treating patients with bladder cancer face complex and potentially life-altering treatment decisions, including whether to prescribe neoadjuvant chemotherapy or proceed directly to radical cystectomy,” said Tina Nova, Ph.D., general manager of Verracyte, Urologic Cancers. . “Studies have shown that knowledge of the molecular subtypes of an individual bladder tumor can help guide these decisions beyond clinical features alone. The coverage decisions announced today will allow 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 are at higher risk for non-organic disease during surgery and which patients may benefit most from neoadjuvant therapy. The test can also be used to identify neuroendocrine and immune-infiltrated subtypes, which may have implications for future therapeutic strategies.
About Deciphering Bladder
Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis of transurethral resected bladder tumor specimens. It was developed for bladder cancer patients with muscle invasive disease facing the issue of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy (NAC). The test results are reported as one of five molecular subtypes (Luminal, Luminal-Infiltrated, Basal, Basal Claudin Low or Neuroendocrine-like), each of which has a different biological composition, clinical behavior and predicted benefit of NAC.
Verracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions and informing diagnosis and treatment decisions throughout the patient’s journey through cancer and other diseases. The company’s growing menu of genomic tests leverages advances in genomic science and technology, allowing patients to avoid risky, expensive diagnostic procedures and speed up the time for appropriate treatment. The company’s tests for lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer and idiopathic pulmonary fibrosis are available to patients and the tests for lymphoma and kidney cancer subtyping are in development. With Verracyte’s exclusive worldwide license for a best-in-class diagnostic instrument platform, the company is positioned to deliver its tests to patients worldwide. Verracyte is based in Southern San Francisco, California. For more information, visit www.verracyte.com and follow the company on Twitter (@verracyte).
Warning Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, our statements regarding our plans, objectives, expectations (financial and otherwise) or intentions. Forward-looking statements can be identified by words such as: “appear”, “anticipate”, “intend”, “plan”, “expect”, “believe”, “could”, “may”, “will”, “positioned”, “designed” and similar references to future periods. Actual results may differ materially from those projected or implied in forward-looking statements. These statements involve risks and uncertainties that could cause actual results to differ materially from our forecasts , and include, but are not limited to, our ability to achieve and maintain Medicare coverage for our tests, including Decipher Bladder. Additional factors that could affect these forward-looking statements can be found in item 1A – ” Risk Factors” in our Annual Report on Form 10-K, filed with the SEC on February 22, 2021 and in our Quarterly Report on Form 10-Q, filed with et the SEC on May 10, 2021. A copy of these documents can be found in the Investors section of our website at: www.verracyte.com. These forward-looking statements speak only as of the date hereof and Verracyte specifically disclaims any obligation to update these forward-looking statements or reasons why actual results may differ, whether as a result of new information, future events or otherwise.
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