Omniseq Receives New York CLEP Approval
News Jul 02, 2016
OmniSeq has received New York State Clinical Laboratory Evaluation Program (CLEP) approval for its OmniSeq ComprehensiveSM panel, a 144 gene, pan-cancer, next-generation sequencing (NGS) tumor profiling diagnostic panel to guide oncology treatment decision-making. OmniSeq Comprehensive provides access to more than 650 therapeutic associations and 850 clinical trial associations, and identifies contraindications for drugs not appropriate for a particular patient.
“OmniSeq is proud to receive New York State CLEP approval for OmniSeq Comprehensive. CLEP is the highest standard of Clinical Laboratory Improvement Amendments (CLIA) laboratory validation,” said Carl Morrison, MD, DVM, President and Chief Scientific Officer of OmniSeq and Executive Director of the Roswell Park Center for Personalized Medicine.
“OmniSeq Comprehensive’s small sample requirements – as little as one tenth of the typical sample requirement, amongst the least in the industry – will enable us to generate complete results from a high proportion of precious samples. This panel enables physicians to zero in on the most important results for patient outcomes.”
According to a November, 2015 article in the Journal of Clinical Oncology (Schwaederle et. al), patients who received targeted therapy in a personalized way based on harboring a molecular biomarker demonstrated significantly better response and survival rates. OmniSeq Comprehensive was developed using Thermo Fisher Scientific’s Oncomine reagents and the Ion Torrent sequencing system, which are also being used by the National Cancer Institute’s (NCI) MATCH trial (NCT02465060) – the largest precision medicine clinical trial of its kind.
Thus, OmniSeq Comprehensive improves patient access to targeted therapeutic options available in clinical trials. As part of OmniSeq’s mission to advance precision medicine, OmniSeq is also proud to announce it is partnering with Cure Forward to help patients control their care and be recruited for clinical trials through its Clinical Trial Exchange. Patients can obtain their OmniSeq Comprehensive test results online and directly apply that information to understand their disease and treatment options.
On Cure Forward’s platform, trial sponsors can identify patients who match their selection criteria and invite them to apply to their studies. “Patients and their families are becoming increasingly active participants in devising strategies for their care. Precision medicine is a framework for matching patients to the particular therapies that match their condition,” said Martin Naley, Founder, Chief Strategy Officer of Cure Forward.
“Cure Forward offers a unique platform that proactively connects patients to clinical trials, which fits perfectly into our mission as we offer patients more than just therapeutically actionable molecular diagnostic testing, but a complete service experience,” said Mark Gardner, Chief Executive Officer of OmniSeq. “Our vision is find the right drug or the right clinical trial for every patient, and our partnership with Cure Forward helps OmniSeq fulfill our promise to patients and providers to deliver the best therapeutic support possible.”