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R&D Alliance Between FDA, NCI, and CMS to Focus on Cancer Biomarkers, PGx; Industry Could Play Role

NEW YORK, Feb. 14 (GenomeWeb News) - The US Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare and Medicaid have created a new Oncology Biomarker Qualification Initiative with an aim of using biomarkers, inlcuding genomic and proteomic markers, to help develop drugs and diagnostics, the agencies announced today.

 

Specific areas of scientific activities include the application of platform technologies for assessing genomic and proteomic alterations, multiplexed molecular assays, and advanced imaging modalities.

 

As part of the alliance, NCI "seeks to develop technologies to improve the detection, diagnosis, treatment, and prevention of cancer;" FDA "is interested in exploring biomarker technologies as assessment tools for use in FDA guidance to facilitate cancer drug development;" and CMS "is interested in the development of evidence to inform reimbursement decisions making about existing or new treatment regimens."

 

"The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients," the partners said in a statement.

 

The first OBQI project will study FDG-PET imaging as a predictor of tumor response in patients with non-Hodgkin's lymphoma.

 

Under the agreement, the three agencies will collaborate to "develop strategic plans, set priorities and leverage resources, including the private sector, toward the goal of improving the clinical utility of biomarker technology," according to a memo released by NCI.

 

OBQI will continue to develop public resources, including databases and lab specimens, and seek input from private sector partners through direct research or funding, the NCI said.

 

Details about the length and funding of the initiative were not immediately available.

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