NEW YORK (GenomeWeb) – Veracyte announced today that it has received regulatory authorization from the New York State Department of Health (NYSDH) to offer the Percepta Bronchial Genomic Classifier in the state.
Percepta, which was launched in April 2015, uses a 23-gene panel to identify patients with lung nodules or lesions who are at low risk of cancer following an inconclusive bronchoscopy result. Veracyte said the test may now be offered to patients with inconclusive bronchoscopy results under its current laboratory permit with the NYSDH while the agency completes its final review.
"This significant milestone underscores the clinical need for and strength of the validation data supporting our test," Veracyte President and CEO Bonnie Anderson said in a statement. "We look forward to offering the Percepta test in New York State as we continue its initial rollout to select institutions around the country."
Last year, Veracyte and collaborators published two studies in the New England Journal of Medicine demonstrating the validity of Percepta's biomarker panel and its efficacy in averting potentially risky lung biopsies.