CARLSBAD, Calif.--(BUSINESS WIRE)--Geneuity, a leader in the integration of molecular diagnostics and pathology testing for pharma, contract research organizations, and medical device companies, today announced that it is expanding early access to Thermo Fisher Scientific’s targeted, next-generation sequencing (NGS) technology and Oncomine Focus Assay for services it plans to offer to its broad pharmaceutical customer base.
Geneuity, a division of Molecular Pathology Laboratory (MPLN), recognizes that pharmaceutical companies not only need access to genomic expertise, but also to multiple platforms and technologies to support oncology clinical research studies. Geneuity’s experience in system evaluation and validation led to the selection of the Ion PGM System and Oncomine Focus Assay, which includes 52 solid tumor genes associated with current oncology drugs and published evidence. Based on Thermo Fisher’s Ion AmpliSeq technology, the assay allows detection of single nucleotide somatic changes, inversions, insertions and deletions as well as gene fusions and copy number variations using as little as 10ng of formalin-fixed paraffin-embedded (FFPE) DNA and RNA.
“The biomarkers included in the Oncomine Focus Assay were selected using the Oncomine Knowledgebase and confirmed with industry leading pharmaceutical companies to help enable a more unified approach to companion diagnostic development,” said Mike Nolan, vice president and general manager of Oncology at Thermo Fisher Scientific. “Coupled with the Ion PGM System, the assay offers a powerful and sophisticated solution for drug development research applications.”
Geneuity’s adoption of the technology comes on the heels of the National Cancer Institute’s Molecular Analysis for Therapy Choice (NCI-MATCH) announcement last month. The trial takes a targeted sequencing approach to analyze up to 3,000 tumor samples using Ion Torrent technology and Oncomine reagents, placing 1,000 eligible patients into one of several treatment arms.
“The outcomes from this trial could eventually help pharmaceutical companies in their drug development endeavors and enable Geneuity’s clients to analyze their clinical research data in the context of the results from this large national study in the future,” said Jamie Platt, Vice President Genomic Solutions for Geneuity.
"We are delighted to be able to add this exciting technology to our service offerings at Geneuity," added Roger A. Hubbard, Ph.D., Geneuity President and Chief Executive Officer. "We believe that the Oncomine suite of tests will contribute to enabling appropriate and optimized therapies in the future."
Geneuity, a division of Molecular Pathology Laboratory (MPLN), is a leader in the integration of molecular diagnostics and pathology testing for pharma, contract research organizations, and medical device companies. We are experienced in outsourced specialty testing and device validation and our expert clinical and scientific staff provides a consultative approach to protocol review and biomarker selection. www.geneuity.com
About Molecular Pathology Laboratory Network, Inc.
Headquartered in Maryville, Tennessee, Molecular Pathology Laboratory Network, Inc. (MPLN) is an ISO15189 certified, CAP accredited and CLIA certified high complexity laboratory specializing in Genomic Solutions and Molecular Anatomic Pathology testing for hematologic and solid tumor oncology. We provide an expanding menu of molecular diagnostics, specialty anatomic pathology, flow cytometry, and cytogenetic testing to uniquely support our clients in pathology groups, hospitals, medical laboratories and physician groups nationwide. MPLN specializes in oncology and women’s health testing, and excels by utilizing highly qualified physicians and innovative technologies, all backed by unparalleled service to meet diagnostic challenges in a timely, cost-effective manner. www.mplnet.com
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.