December 18, 2014
MolecularMD Cambridge Laboratory Receives CAP Accreditation with Focus on NGS Panels for Clinical Trial Enrollment and NGS Liquid Biopsy Testing
PORTLAND, OR and CAMBRIDGE, MA – December 18, 2014 – MolecularMD, Corp., a molecular diagnostics company that develops custom companion diagnostic products and supports clinical trial services for targeted cancer therapies, today announced that it has received accreditation from the College of American Pathologists (CAP) for its Next Generation Sequencing (NGS) Laboratory in Cambridge, MA. To complement its Portland based RT-PCR and IHC companion diagnostic capabilities, the Cambridge laboratory was established in 2012 as an Advanced Diagnostics Development Laboratory for NGS.
MolecularMD has developed a wide range of NGS cancer panels on multiple leading platforms, using proprietary chemistries and data analysis pipeline; it specializes in the design and validation of both tissue and blood-based custom assays for retrospective evaluations and prospective clinical trial enrollment. “Combining our expertise in NGS assay development and robust analytical assay validation process, we offer our clients the highest quality data for drug development and clinical decision-making,” commented Dr. Jin Li, Scientific Director of Advanced Diagnostics at Cambridge Laboratory.
MolecularMD’s Cambridge CAP laboratory has been at the forefront of validating methods and platforms for circulating tumor DNA analysis (ctDNA), also known as liquid biopsy.
The Ion AmpliSeq™ Cancer Hotspot Panel v2 (CHP) has been recently validated for multiplex detection of somatic “hotspot” mutations with less than 1% allele frequency in ctDNA.
MolecularMD has also adopted the Oncomine™ Cancer Research Panel for broad cancer genome analysis of mutations, copy number alterations and fusions. The panel test workflow supports rapid turn-around times to address recruiting of patients in early phase trials.
The CAP Laboratory Accreditation Program is to improve patient safety by advancing the quality of pathology and laboratory services through education, standard setting, and ensuring laboratories meet or exceed regulatory requirements. The CAP accreditation endorses MolecularMD’s dedication to go well beyond regulatory compliance to achieve the highest standards of excellence to positively impact patient care.
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.
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