HTG Molecular Diagnostics Granted License for Breast Cancer Markers

HTG Molecular Diagnostics (Tucson, AZ, USA) has been granted a nonexclusive license by Merck (Whitehouse Station, NJ, USA) to develop, manufacture, and commercialize breast cancer diagnostic tests. The Netherlands Cancer Institute (Amsterdam, The Netherlands) is a co-owner of patents and applications in Merck's patent portfolio.

HTG Molecular Diagnostics is a privately held company providing products for gene expression profiling, microRNA (miRNA), and mRNA measurement for clinical research, companion diagnostic and prognostic applications in oncology. The company's qNPA molecular technology platform is well suited for reliably detecting changes in gene expression levels especially from formalin-fixed paraffin-embedded (FFPE) tissue.

qNPA technology simultaneously measures up to 47 genes in the same well. It provides a reproducibly accurate measure of the gene expression levels in a wide range of cell types and requires no RNA extraction, no RNA amplification, and no RNA labeling. HTG Molecular solutions are not sensitive to preanalytic process steps and deliver accurate, reproducible results on FFPE samples of nearly any tissue in any condition.

T.J. Johnson, CEO of HTG Molecular Diagnostics said that the ability to quickly, and locally assess a patient's likelihood to have recurrent breast cancer would help improve patient care in the era of personalized medicine.

"Most breast cancer risk testing is currently run at a few specialty laboratories which often take weeks to return results to treating physicians and nervous patients," Johnson added.

"As part of our IVD pipeline development, HTG Molecular Diagnostics intends to pursue FDA approvals for tests that provide compelling medical value and to make those standardized tests available to local laboratories via proprietary automation and content.

"This patent portfolio license from Merck gives HTG access to key intellectual property to bring valuable breast cancer tests to market."

In 2011 there were more than 250,000 new breast cancer cases diagnosed in the United States. These patients have a varying degree of risk of cancer recurrence based on genetic and environmental factors. Those breast cancers less likely to recur can be treated with less aggressive therapy approaches. Genetic profiling or gene expression offers the possibility of improving risk prediction and optimizing treatment selection for individual patients.

Related Links:
HTG Molecular Diagnostics
Merck
Netherlands Cancer Institute