MolecularMD Corp., a molecular diagnostics company that provides companion diagnostic solutions and supporting clinical trial testing services for targeted cancer therapies, received approval from the New York State Department of Health (NYDOH) for its Next Generation Sequencing (NGS) Notch 1 gene mutation analysis in FFPE tissue and whole blood specimens. The test is intended to support clinical trial enrollment.
Notch1 mutations have been linked to refractory lymphoid malignancies such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma, and others, putting patients at greater risk for poor outcomes and reduced overall survival.
The approval was based on New York State’s “NGS guidelines for somatic genetic variant detection.” The guidelines cover all aspects of ensuring accurate test performance including validation, quality control, and reporting. The NYDOH guidelines are considered to be one of the most comprehensive NGS guideline references by a government body. Tests submitted for approval are given meticulous evaluation.
MolecularMD designed the Notch 1 test and related workflow to meet a five day turnaround time to support rapid clinical decision making necessary for patient enrollment. Many NGS testing methods require a 2 – 3 week turnaround time from sample receipt to patient report, which significantly hinders the use of NGS in prospective clinical trials. In partnership with program sponsors, MolecularMD has designed proprietary workflows and bioinformatics analyses that meet the clinical protocol and IRB requirements for cancer patient management and enrollment.
“Meeting clinical trial protocol requirements while also maintaining the highest government standards for quality and validation is the trademark of MolecularMD,” comments Dan Snyder, President and CEO. “Targeted therapy programs need accurate results quickly in a manner that allows their principal investigators to get their drug to patients while delivering upon regulatory requirements for drug–diagnostic approvals.”
July 16, 2015