CARLSBAD, Calif.—Geneuity, which boasts skills in the integration of molecular diagnostics and pathology testing for contract research organizations (CROs), pharmaceutical companies and medical device companies, announced this summer that it is expanding early access to Thermo Fisher Scientific’s targeted, next-generation sequencing technology and Oncomine Focus Assay for services that it plans to offer to its broad pharmaceutical customer base.
“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, a division of Molecular Pathology Laboratory Inc., says it recognizes that pharmaceutical companies not only need access to genomic expertise, but also to multiple platforms and technologies to support oncology clinical research studies. It was Geneuity’s experience in system evaluation and validation that prompted it to choose 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 10 ng of formalin-fixed paraffin-embedded DNA and RNA.
“We are delighted to be able to add this exciting technology to our service offerings at Geneuity,” enthused Dr. Roger A. Hubbard, Geneuity’s president and CEO. “We believe that the Oncomine suite of tests will contribute to enabling appropriate and optimized therapies in the future.”
Geneuity’s decision to adopt the Thermo technology came immediately in the wake of an announcement the previous month of the launch of the National Cancer Institute’s Molecular Analysis for Therapy Choice (NCI-MATCH) trial, in which patients will undergo biopsy with genomic analysis of their tumors to identify specific molecular abnormalities and then be assigned to the most relevant targeted therapy available, including both currently marketed drugs and investigational agents—an effort that will be the largest precision oncology trial ever. NCI-MATCH will be taking a targeted sequencing approach to analyze as many as 3,000 tumor samples using Thermo’s 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,” according to Jamie Platt, vice president of genomic solutions for Geneuity.
The news of Geneuity adopting Thermo technology came out just ahead of Thermo Fisher announcing a joint venture with the Special Bacteriology Reference Laboratory at the U.S. Centers for Disease Control and Prevention (CDC), in which they have collaborated to develop an advanced software solution to enable global public health laboratories to directly access the CDC’s MicrobeNet online virtual reference lab database. With the software, researchers reportedly will be able to more quickly identify microbial pathogens potentially at the root of global outbreaks without needing to refer to multiple databases by instead utilizing one curated by subject matter experts in the field.
Molecular Pathology Laboratory Network 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. Its Geneuity division—in carrying out integration of molecular diagnostics and pathology testing for pharmas, CROs and medical device companies—stresses its experience in outsourced specialty testing and device validation, as well as a “consultative approach to protocol review and biomarker selection.”
Thermo Fisher is one of the global leaders in serving science needs, including the life sciences, with revenues of $17 billion and approximately 50,000 employees in 50 countries through its premier brands: Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services.