MolecularMD has received certification of its Next Generation Sequencing (NGS) clinical lab in Cambridge, MA under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. CLIA establishes quality standards for lab testing to help ensure accuracy, reliability and timeliness of test results, regardless of where the test is performed.
The Cambridge lab provides custom solutions for NGS-based companion diagnostics to support early stage and pivotal clinical studies. The company has developed a range of NGS cancer panels and specializes in the design and validation of tissue and blood-based panels to explore drug-relevant genomic regions for evaluations and prospective clinical trial enrollment.
"We are working productively with several top pharmaceutical clients to meet their biomarker evaluation and companion diagnostic requirements, supporting early stage proof-of-concept as well as drug/diagnostic co-development programs for FDA approval. We are pleased to now offer CLIA-certified NGS services in Cambridge; this capability enhances our flexibility and broadens our service offerings to accommodate clinical trial testing needs," said Dr. Glenn Miller, executive vice president and chief technology officer.