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MolecularMD Lands NY State Approval for Notch 1 Mutation Test

NEW YORK (GenomeWeb) – MolecularMD today announced it has received approval from the New York State Department of Health for its Notch 1 gene mutation test.

The next-generation sequencing-based test is intended to support clinical trial enrollment, the firm said in a statement, and uses FFPE tissue and whole blood samples. The test has a five-day turnaround time.

Notch 1 mutations have been linked to cancers such as chronic lymphocytic leukemia and mantle cell lymphoma and put patients at greater risk for poor outcomes and reduced overall survival.

"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," MolecularMD CEO Dan Snyder said in a statement.

Portland, Oregon-based MolecularMD develops companion diagnostic testing for cancer treatments.

In March, the firm received ISO 13485:2003 Certification.