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MolecularMD Licenses NYU, MSKCC Patents to Develop PGx Test for BRAF Mutation

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Pharmacogenomic test developer Molecular MD has been granted a license by New York University and Memorial Sloan-Kettering Cancer Center to intellectual property pertaining to detecting the BRAF V600E mutation, the company said this week.

MolecularMD, a Portland-based spinout of Oregon Health and Science University, said it will use the IP to develop a sensitive, clinically validated test to help identify cancer patients likely to benefit from treatment with BRAF inhibitors.

The licensing agreement specifically pertains to US Patent No. 7,442,507B2, which describes the diagnostic use of a fluorescent-based, allele-specific PCR assay to amplify the V600E mutation.

MolecularMD said the described method is more sensitive than traditional direct Sanger sequencing and can detect BRAF mutations in both tumor and lymph node biopsies. The method can also be used to detect mutant BRAF in blood samples, the company noted.

The BRAF protein kinase is a key element of the RAS/RAF/MAPK signaling pathway and has been demonstrated as a major regulator of cell proliferation and survival, and hyperactivation of the pathway is frequently observed in human malignancies, MolecularMD said.

According to the company, BRAF mutations have been found in 8 percent of human cancers, including half of all melanomas, 30 percent to 70 percent of thyroid cancers, 30 percent of serious low-grade ovarian cancers, and 10 percent of colorectal cancers.

As such, the BRAF mutation is of significant interest to pharmaceutical companies developing targeted, molecular cancer therapeutics, Molecular MD said. The company provided as an example the BRAF inhibitor RG7204, from Hoffman-La Roche, which has demonstrated promising efficacy, especially among melanoma patients harboring the BRAF V600E mutation.

MolecularMD spun out of OHSU in 2006, and has licensed exclusive commercial rights to patented mutation discoveries made by OHSU researchers Brian Druker and Amie Corbin in the area of BCR-ABL testing.

The company said that its strategy is to partner with academic organizations and pharmaceutical companies to support development of molecular cancer therapies, and provide diagnostic tests and clinical trial services.

In April 2009, MolecularMD granted a sub-license to the Mayo Clinic for methods of detecting ABL kinase mutations in chronic myelogenous leukemia patients.

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