Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Guidelines for Ancient DNA Work

More than two dozen researchers have developed new ethical guidelines for conducting ancient DNA research, which they present in Nature.

And Cleared

A UK regulator has cleared former UK Prime Minister David Cameron in concerns he should have registered as a consultant-lobbyist for his work with Illumina, according to the Financial Times.

Suit Over Allegations

The Boston Globe reports that David Sabatini, who was placed on leave from MIT after allegations of sexual harassment, is suing his accuser, the Whitehead Institute, and the institute's director.

Nature Papers on Esophageal Cancer, Origin of Modern Horses, Exome Sequencing of UK Biobank Participants

In Nature this week: genetic and environmental influences of esophageal cancer, domestic horse origin traced to Western Eurasian steppes, and more.