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Veracyte Licenses Lung Disease Genomic Classifier From Yale University

This article has been updated from a previous version to include clarifying information from Veracyte about the developers of the gene signature.

NEW YORK – Veracyte said on Thursday that it has signed an exclusive licensing agreement with Yale University for a genomic test to predict 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, which Veracyte exclusively licensed from NanoString Diagnostics in late 2019 for diagnostic use.

Veracyte said that it 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 IPF patients.

The 52-gene signature was developed by Naftali Kaminski, chief of pulmonary, critical care, and sleep medicine at Yale School of Medicine; Jose Herazo-Maya, currently director of the Interstitial Lung Disease Program at NCH Healthcare System of Naples, Florida; and collaborators at the University of Virginia and University of Arizona College of Medicine.

Researchers have demonstrated that the genomic profiler was substantially more accurate at identifying IPF patients with poor outcomes as compared to a traditional assessment using clinical variables, work that was published in Science Translational Medicine in 2014. These findings were subsequently validated in an international multicenter study published in Lancet Respiratory Medicine.

"We are excited to advance groundbreaking research from Dr. Kaminskiand his team into a commercially available, first-of-its-kind genomic test that may further help guide care for patients with IPF," Veracyte Chairman and CEO Bonnie Anderson said in a statement.

"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," Anderson added. "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."

Veracyte and Yale also announced a research agreement with 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.

In early Thursday trading on the Nasdaq, Veracyte's shares were up about 2 percent at $23.85. The company said last week that it expects first quarter revenues of $30.5 million to $31.5 million, which would be a 3 percent to 7 percent year-over-year increase.