Veracyte to couple Yale genomic test with its pulmonary fibrosis diagnostic

Veracyte has been granted an exclusive license to a genomic blood test developed at Yale University capable of predicting the progression of idiopathic pulmonary fibrosis, or IPF.

The test checks for a signature made of 52 genes that can gauge whether a person’s disease could rapidly worsen, a diagnostic tool Veracyte describes as one of the first of its kind.

The company plans to offer the test on its recently acquired nCounter FLEX Analysis System and alongside its Envisia Genomic Classifier, which is used to differentiate IPF from other lung diseases to help diagnose the condition without a surgical procedure or high-resolution CT imaging.

Adding prognostic information to the company’s Envisia classifier will provide a more comprehensive product, said Chairman and CEO Bonnie Anderson, as Veracyte aims for a global market rollout in 2021.

In the U.S. and Europe, up to 200,000 patients are evaluated for interstitial lung diseases each year, the company said, with a median survival of about three years following IPF diagnosis.

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“The clinical implications of predicting outcomes in IPF are substantial,” said Naftali Kaminski, pulmonary section chief at Yale University’s School of Medicine, whose team developed the test.

“For example, knowing which patients are likely to rapidly progress could allow more accurate and timely referral to appropriate treatments,” Kaminski said. “The implications for clinical trials and new drugs coming to the patients are also important because information about individual patients’ potential outcomes will allow better stratification of patients for trials and eventually tailoring of IPF therapies.”

Veracyte also inked a research agreement with Kaminski’s lab to explore the genomic basis for other lung-scarring diseases as well as additional tools for IPF diagnosis.

Previous studies of the 52-gene signature found it was more accurate at identifying patients that would go on to have poorer outcomes, compared to analyses using clinical variables, and validated its use in a multicenter trial.