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UPDATE: HTG, John Wayne Cancer Institute Partner on Melanoma Assays

This article has been updated with comments from HTG's CEO and additional background information.

NEW YORK (GenomeWeb News) – HTG Molecular Diagnostics today said that it has partnered with the John Wayne Cancer Institute to commercialize melanoma assays based on molecular signatures identified through a research collaboration between the partners.

Tucson, Ariz.-based HTG said that it developed research assays and analyzed more than 400 annotated cases of melanoma, which resulted in several promising signatures. The firm said that it will now work on a commercialization strategy, which may include licensing the signatures to reference labs or submitting assays to the US Food and Drug Administration for clearance.

Financial and other terms of the partnership were not disclosed.

HTG and JWCI have been collaborating for the past two years on finding molecular signatures for melanoma. The collaboration is ongoing and is focused on the melanoma continuum, HTG CEO TJ Johnson told GenomeWeb Daily News today. JWCI has been contributing annotated samples and medical expertise, while HTG has been contributing its technology and assay development, as well as conducting analysis of the signatures.

In effect, the agreement grants HTG an exclusive license to JWCI's part of the ownership of the IP for commercialization of diagnostic and prognostic signatures, said Johnson.

The tests developed by HTG will be multiplexed gene expression assays, he added. "Our focus of the collaboration has been on the entire melanoma continuum, so our expectation is that over time we will identify multiple signatures that have a medical utility throughout the continuum," Johnson said.

He said it's hard to predict when the first test from the collaboration with JWCI will be commercialized, but he added that the firm expects it would be "in commercialization mode late this year or early next year."

HTG doesn't have any FDA-cleared products on the market. It is currently validating signatures that it expects to bring through the regulatory process, and it anticipates its first multiplex assay — for non-small cell lung cancer — to go to FDA by the end of this year. After that, HTG expects to file around two products for year for FDA approval, said Johnson.

In addition to the NSCLC assay and the melanoma signatures, the firm is working on signatures for diffuse B-cell lymphoma and breast cancer. HTG also is developing its own instrumentation to run its assays and is in the process of building its commercialization operations.

A year ago, the firm raised $16.2 million in a Series D round of financing to support development of its instrument platform and its R&D and commercialization efforts.

Earlier this year, HTG inked an agreement with Sanofi to identify biomarkers that could potentially be used in a companion diagnostic test for an undisclosed investigational drug being developed by Sanofi.

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