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Veracyte Bladder Cancer Test Receives Medicare Coverage

NEW YORK – Veracyte announced on Friday that its Decipher Bladder test for cancer will be covered under a future local coverage determination from Medicare.

Under the determination from Medicare Administrative Contractor Palmetto GBA, molecular diagnostic tests for use in a patient with bladder cancer will be covered when the patient is actively being managed for bladder cancer; is within the population and has the indication for which the test was developed and is covered; and is a candidate for multiple potential treatments with varied or increasing levels of intensity based on a consensus guideline or is a candidate for multiple therapies, where the test has shown it predicts response to a specific therapy.

The test must demonstrate analytical validity, and, if based on an algorithm, the algorithm must be validated in a cohort that isn't a development cohort for the algorithm. It must also demonstrate clinical validity and utility and complete a Molecular Diagnostic Program technical assessment.

Fellow MACs CGS Administrators and Wisconsin Physicians Service Insurance Corporation have aligned their coverage with Palmetto's. The LCDs will go into effect on July 18.

Veracyte's Decipher Bladder is a genomic test that uses gene expression analysis from transurethral resected bladder tumor specimens. It can be used 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. It can also be used to identify neuroendocrine-like and immune-infiltrated subtypes, the company said in a statement.

In Friday morning trade on the Nasdaq, shares of Veracyte were up around 3 percent at $34.97.

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