Veracyte Inc has signed an exclusive licensing agreement with Yale University to advance the first genomic test for predicting disease progression in patients with idiopathic pulmonary fibrosis (IPF).

The agreement gives Veracyte rights to a 52-gene signature developed by Yale researchers, for use on the nCounter FLEX Analysis System – Veracyte’s exclusively licensed diagnostics platform. Veracyte plans to make the non-invasive, blood-based test available as a complement to its Envisia Genomic Classifier, as part of a comprehensive offering to aid in the diagnosis and treatment of patients with IPF.

The 52-gene signature in peripheral blood, developed by Dr. Naftali Kaminski, chief of the Section of Pulmonary, Critical Care and Sleep Medicine in the Department of Medicine at Yale University’s School of Medicine, Dr. Jose Herazo-Maya, currently Director of Interstitial Lung Disease Program NCH Healthcare System, Naples, Fla. and collaborators*, is shown to predict rapid disease progression among patients with IPF. In a study published in Science Translational Medicine, the genomic profile was substantially more accurate at identifying patients with poor outcomes as compared to a traditional assessment using clinical variables. The findings were subsequently validated in an international multicenter study published in Lancet Respiratory Medicine.

“We are excited to advance groundbreaking research from Dr. Kaminski and his team into a commercially available, first-of-its-kind genomic test that may further help guide care for patients with IPF,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “The addition of prognostic information to our Envisia classifier, which is already available as a genomic tool to help improve IPF diagnosis, enhances the value of this test for physicians and patients as we prepare it for global market expansion on the nCounter platform in 2021. This agreement was enabled by Veracyte’s December 2019 acquisition of the exclusive global diagnostics rights to the nCounter platform, and further underscores the strategic value of that transaction to our company.”

Each year in the United States and Europe, up to 200,000 patients are evaluated for suspected interstitial lung diseases (ILDs), including IPF, which is among the most common, deadly and difficult to diagnose of these lung-scarring diseases. Median survival following IPF diagnosis is approximately 2.5 to 3.5 years. In recent years, antifibrotic therapies have helped extend survival for some patients.

“The clinical implications of predicting outcomes in IPF are substantial,” said Dr. Kaminski. “For example, knowing which patients are likely to rapidly progress could allow more accurate and timely referral to appropriate treatments. 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 and Yale University also announced a research agreement with Dr. Kaminski’s lab aimed at further elucidating the genomic underpinning of interstitial lung diseases (ILDs), with the potential to further inform diagnosis and treatment decisions for patients with ILDs, including IPF.

“IPF is an overwhelming diagnosis for many patients and their caregivers,” said Dr. Gregory Cosgrove, chief medical officer of the Pulmonary Fibrosis Foundation. “Any additional, reliable information we can provide regarding their personal disease status will not only help guide important decisions, including individual treatment plans, but could help reduce anxiety and fear.”