NEW YORK (GenomeWeb) – The National Biomarker Development Alliance and the Children's Tumor Foundation announced on Thursday a partnership aimed at advancing biomarkers for neurofibromatosis, a genetic disorder that causes tumors to grow in the nervous system.
The partners will create a center tasked with discovering and developing biomarkers of pediatric brain tumors with a focus on NF1-associated tumors. NF1 is the most common type of neurofibromatosis, which the partners said is generally considered a disease resulting from genomic alterations. While research has provided some information about the molecular mechanisms of tumor development in NF1, few if any biomarkers exist for the prognosis of the disease, NBDA and CTF said.
The center will use an evidence-based approach to evaluate biomarkers, prioritize them for development, and move them into qualification and validation studies. Qualification studies will be pursued under the US Food and Drug Administration biomarker qualification program, the organizations said.
They added that biomarkers that are developed through qualification will follow the incremental process implemented by NBDA as part of its program to advance biomarkers for clinical use. The new center will make its data and processes publicly available to the broader research community for work into all pediatric brain tumors.
"This partnership will also serve to provide a rational basis for clinical trials and can overall become a model for other rare, and relatively rare, tumors in addition to NF," CTF President and CSO Annette Bakker said in a statement.