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MolecularMD Receives CLIA Certification for Second Lab

NEW YORK (GenomeWeb News) – Molecular diagnostics company MolecularMD has received CLIA certification for its next-generation sequencing laboratory in Cambridge, Mass.

The laboratory was originally established as a development center for next-gen sequencing and has been expanded to provide next-gen sequencing-based clinical testing to support clinical trials.

The firm's Portland, Ore.-based laboratory received CLIA certification in 2006.

"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," Chief Technology Officer Glenn Miller said in a statement.

MolecularMD has developed a number of NGS-based cancer panels that target genomic regions containing genes that are the target of drugs or related to drug response or resistance. For instance, it recently published on custom NGS cancer panels for gastrointestinal stromal tumors, the detection of a specific EGFR mutation in plasma, LKB1/STK11 mutations, and drug resistance conferring mutations to BCR-ABL1.

The company has proprietary chemistry and data analysis pipelines that enable it to detect insertions and deletions up to 50 base pairs and to phase the mutations.