SOURCE: MolecularMD

MolecularMD

October 18, 2010 07:00 ET

MolecularMD Corp. Obtains Exclusive License From NYU and MSKCC for BRAF Melanoma Assay

PORTLAND, OR--(Marketwire - October 18, 2010) - MolecularMD Corp. announced today that it has entered into a licensing agreement with New York University (NYU) and Memorial Sloan-Kettering Cancer Center (MSKCC). The agreement grants MolecularMD exclusive US commercial rights to patented intellectual property pertaining to the detection of the BRAF V600E mutation (US patent No. 7,442,507 B2).

MolecularMD partners with both academic and pharmaceutical organizations to support the development of molecular cancer therapies. The company provides highly validated diagnostic tests and clinical trial services necessary to advance personalized cancer treatment.

The BRAF protein kinase is a key element of the RAS/RAF/MAPK signaling pathway and has emerged as a major regulator of cell proliferation and survival. Hyperactivation of this pathway is frequently observed in human malignancies. Mutations in BRAF have been found in 8% of human cancers, including 50% of melanomas, 30% to 70% of thyroid cancers, 30% of serous low-grade ovarian cancers, and 10% of colorectal cancers. The majority of BRAF mutations detected in tumors are substitutions of a single amino acid in the kinase domain (V600E).

Given this association with a variety of human malignancies, the BRAF protein is of significant interest to pharmaceutical companies developing targeted, molecular cancer therapeutics. A recent clinical trial of the BRAF inhibitor RG7204 (F. Hoffmann-La Roche Ltd, Basel, CH) demonstrated promising efficacy, specifically among melanoma patients who harbor the BRAF V600E mutation. Development of a sensitive, clinically-validated test to identify patients likely to benefit from such potentially life-saving therapies will help physicians not only better predict effectiveness, but also monitor progress and make more informed treatment decisions.

The BRAF detection method patent issued to NYU and MSKCC was developed by two associate professors at NYU Langone Medical Center, David Polsky MD, PhD, associate professor, Departments of Dermatology and Pathology, Iman Osman, MD, associate professor of dermatology, urology and medicine, and Paul B. Chapman, MD, attending physician, Melanoma Sarcoma Service of Memorial Sloan-Kettering Cancer Center. The patent describes the diagnostic use of a fluorescent-based, allele-specific PCR assay that amplifies the V600E mutation. The allele-specific technology is more sensitive than traditional direct Sanger sequencing and can detect BRAF mutations in both tumor and lymph node biopsy samples. The method can also be utilized to accurately detect mutant BRAF in blood samples. 

According to Dr. Polsky, "Determining the mutational status of a solid tumor using non-invasive methods represents a highly innovative advance in cancer treatment. The rapid and accurate detection of mutant BRAF alleles in the blood of patients with metastatic melanoma may give the clinician valuable information about the disease status of a patient in a real-time, cost-effective fashion."

Through its partnerships with these cancer research institutions and ongoing clinical research efforts, MolecularMD is commercializing assay technology to meet the current and future companion diagnostic requirements for melanoma molecular therapies. 

For additional information, please contact MolecularMD at 1-877-459-4979 or visit our website at www.molecularmd.com

About MolecularMD:

MolecularMD is a private company that specializes in the development and commercialization of pharmacogenomic tests designed to select, monitor, and manage patients treated with targeted molecular cancer therapies. The company stems from prominent clinical research leadership from Oregon Health and Science University and has developed sensitive and highly reliable molecular assays for a range of blood based and solid tumor malignancies.

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