Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Genetic Tests Lead to Potential Prognostic Variants in Dutch Children With Dilated Cardiomyopathy

Researchers in Circulation: Genomic and Precision Medicine found that the presence of pathogenic or likely pathogenic variants was linked to increased risk of death and poorer outcomes in children with pediatric dilated cardiomyopathy.

Fragile X Syndrome Mutations Found With Comprehensive Testing Method

Researchers in Clinical Chemistry found fragile X syndrome expansions and other FMR1 mutations with ties to the intellectual disability condition using a long-range PCR and long-read sequencing approach.

Team Presents Strategy for Speedy Species Detection in Metagenomic Sequence Data

A computational approach presented in PLOS Computational Biology produced fewer false-positive species identifications in simulated and authentic metagenomic sequences.

Genetic Risk Factors for Hypertension Can Help Identify Those at Risk for Cardiovascular Disease

Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.