MolecularMD Receives CLIA Certification for Its Second Next Generation Sequencing Laboratory

PORTLAND, OR and CAMBRIDGE, MA--(Marketwired - Apr 4, 2014) - MolecularMD, Inc., a molecular diagnostics company that provides custom companion diagnostic solutions and supporting clinical trial services for targeted cancer therapies, today announced certification of its Next Generation Sequencing (NGS) clinical laboratory in Cambridge, Massachusetts under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The Cambridge lab complements MolecularMD's Portland, OR CLIA lab and GMP manufacturing facility to provide custom solutions for NGS-based companion diagnostics. The lab was initially established as a development center of excellence for NGS and has now been expanded as a dedicated center for NGS clinical testing under CLIA to support early stage and pivotal clinical studies.

MolecularMD has developed a wide range of NGS cancer panels; it specializes in the design and validation of tissue and blood-based custom panels to query drug-relevant genomic regions for retrospective evaluations and prospective clinical trial enrollment. 

Recently, the company published on several custom NGS assays for applications including Gastrointestinal Stromal Tumors (c-KIT, PDGFR, PTEN, PIK3CA), Non-Small Cell Lung Cancer (ALK, EGFR, KRAS), Plasma-Based EGFR T790M Detection, LKB1/STK11 Mutations, and BCR-ABL1 Drug Resistance. 

Employing a range of platforms and bioinformatics methods, MolecularMD has developed proprietary chemistries and data analysis pipelines that enable it to offer more comprehensive genotyping interrogation, including detection of large insertions and deletions (up to approximately 50 base pairs) and determination of mutation phasing for various applications. These capabilities highlight MolecularMD's commitment to offering its clients the highest quality, actionable data for drug development and clinical decision-making. 

CLIA-based NGS has been performed in MolecularMD's Portland facility since early 2013. The addition of Cambridge NGS CLIA provides for more rapid validation and implementation for clinical studies. "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," commented Dr. Glenn Miller, EVP and Chief Technology Officer. 

About MolecularMD

MolecularMD Corporation develops and commercializes specialty molecular diagnostics for oncology applications. Its tests are designed to allow appropriate selection, monitoring and management of patients treated with molecularly-targeted cancer therapies. MolecularMD integrates gold-standard and innovative platform technologies with custom clinical assay design and validation to accelerate all phases of clinical development, including FDA approval and commercialization of in vitro companion diagnostic tests for novel anticancer agents. A private company based in Portland, Oregon, MolecularMD was founded by Dr. Brian Druker, director of the Knight Cancer Institute at Oregon Health & Science University, and Sheridan G. Snyder, entrepreneur and founder of Genzyme Corporation.

References

Phasing Analysis of TKI Resistance Mutations in the BCR-ABL1 Kinase Domain and Neighboring Domains Using Next-Generation Sequencing; Blood (ASH Annual Meeting Abstracts) 2013(21): Abstract 3817

Obtaining Maximal Information from Limited FFPE Tissue Specimens: Development and Validation of a 4-Gene Custom NGS Panel for a GIST Clinical Trial; ASCO-EORTC-NCI Markers in Cancer 2013 Poster; EJC 49, Suppl 4, MC13-0069

Mutation detection in FFPE and plasma circulating DNA with a focused ALK-EGFR-KRAS Next-Generation Sequencing panel; AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2013 Poster

Complementary Analysis of LKB1/STK11 Mutation and Protein Expression Status using Next-Generation Sequencing, Sanger Sequencing and Immunohistochemistry; AACR Annual Meeting Poster 2013: Abstract 3509

Highly Sensitive Detection of EGFR T790M on Ion Torrent PGM; AACR Annual Meeting Poster 2013: Abstract 3490

Next-Generation Sequencing of the BCR-ABL1 Kinase Domain and Neighboring Domains Associated with Therapy Resistance; Blood (ASH Annual Meeting Abstracts) 2012 120: Abstract 2549