PORTLAND, OR--(Marketwired - Apr 4, 2013) - Today MolecularMD Corp. announced the launch of its next generation sequencing (NGS) services designed to support MolecularMD's pharmaceutical and biotechnology partners' clinical trials as well as companion diagnostics development initiatives. Focusing on targeted cancer therapeutic development, MolecularMD offers custom designed and validated NGS panels to meet partners' needs in profiling a broad range of gene alterations relevant to therapeutic response or resistance. Testing is being performed in MolecularMD's CLIA-certified, CAP-accredited laboratory and compliments the company's other oncology biomarker testing services.
Since establishing its dedicated NGS laboratory in Cambridge, MA, MolecularMD has cross-validated two NGS cancer panels that are commercially available for two independent platforms: Life Technologies Ion Personal Genome Machine® (PGM) and Illumina MiSeq® Personal Sequencer. In addition, the laboratory has designed and validated custom panels for profiling sets of genes that are of particular interest in targeted drug development for non-small cell lung cancer, melanoma, GIST, and chronic myeloid leukemia.
Jin Li, Ph.D., MolecularMD's Research Director for Advanced Diagnostics, commented, "The workflow improvements we have made in library preparation techniques as well as our proprietary data analysis pipeline enable better analytical test performance and reduce turnaround time. These advances also aid in our development of custom panels designed specifically to meet our partners' needs. We have presented some of our validation work at recent AMP and ASH meetings, and more will be presented at the upcoming AACR meeting in April."
According to Cindy Spittle, Ph.D., Director, Scientific Affairs at MolecularMD, "The high-sensitivity multiplex analyses that can be achieved with NGS enable multiple genetic queries within a single clinical sample. This specimen-preserving efficiency is advantageous for early identification of genetic signatures that may define patient populations most likely to benefit from a given therapy. We are pleased to be supporting several of the industry's leading oncology drug developers with NGS testing services. We look forward to expanding our services as the advantages of MolecularMD's custom NGS panels become more broadly recognized."
In anticipation of 510K clearance of the PGM platform, MolecularMD is planning to conduct NGS panel development under design control processes for clinical trials assays. This will ensure smooth transitions and streamline regulatory compliance as clinical trial assays pave the way for companion diagnostics with the progression of drug candidates toward registration.
The NGS CLIA/CAP testing is currently performed out of the MolecularMD's Portland laboratory.
MolecularMD Announces Presentations at upcoming American Association of Cancer Research Meeting
MolecularMD Corp. will present data at the annual meeting of the American Association of Cancer Research Annual Conference, April 7-9th in Washington, D.C. These poster presentations demonstrate MolecularMD's ongoing leadership as a provider of innovative and reliable molecular diagnostic solutions.
MolecularMD AACR Poster Presentation Schedule
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 incorporates gold-standard and innovative technologies in providing its partners with the highest quality results. Assays are designed to meet clinical trial needs, and MolecularMD has appropriate systems and standards in place to enable development of companion diagnostic tests in conjunction with partners' 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.