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Promise of personalized medicine
SAN DIEGO—Molecular medicine examines the ways in which illness and disease develop or can be prevented at the cellular or molecular level, according to the American Medical Association, and various kinds of technology have put clinicians on the cusp of using personalized molecular medicine for a variety of diagnostics and therapeutics.
Invivoscribe Technologies Inc., a privately held biotechnology company specializing in personalized molecular diagnostics and personalized molecular medicine, has entered a long-term collaboration with Thermo Fisher Scientific Inc. to develop multiple next-generation sequencing (NGS)-based, in-vitro diagnostic (IVD) oncology tests on the Ion PGM Dx System. The assays may become powerful tools for diagnosis and minimal residual disease (MRD) monitoring of the full range of hematologic malignancies.
According to Dr. Jeffrey Miller, CEO of Invivoscribe, “This agreement further solidifies Invivoscribe’s dedication to providing, on a worldwide basis, clinically actionable tests for personalized molecular medicine. Our tests are used to better diagnose, stratify and monitor a full range of hematologic malignancies. Through our collaboration, we will leverage Thermo Fisher’s cutting-edge NGS technology and Invivoscribe’s development expertise in cancer diagnostics and regulatory and quality systems to provide diagnostic tests with superior clinical sensitivity. We are also very excited to provide our optimized NGS tests with comprehensive bioinformatics software, so our customers can perform the entire testing and reporting process, including MRD testing, within their laboratories.”
Thermo Fisher Scientific, one of the largest global providers of products for life-sciences and analytical research, diagnostics and laboratory productivity, has revenues of $17 billion and more than 50,000 employees in 50 countries. Based in Waltham, Mass., its premier brands are Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services.
“Thermo Fisher is committed to collaborating with strategic partners who share our drive to help make precision medicine a reality,” said Joe Bernardo, president of clinical sequencing at Thermo Fisher. “We look forward to providing our expertise and next-generation sequencing diagnostic system, which will serve as the foundational platform for an expanding line of Invivoscribe NGS oncology assays.”
Invivoscribe brings more than two decades of development, validation and commercialization experience to manufacturing and commercializing immuno-oncology molecular diagnostics and associated bioinformatics software for application in liquid biopsies. The company provides ISO13485-certified GMP manufactured PCR- and NGS-based reagents, RUO test kits and CE-marked IVDs, including IdentiClone, LymphoTrack and LymphoTrack Dx assays for clonal, MRD and somatic hypermutation testing. Invivoscribe’s clinical laboratories in the United States, Europe and Japan offer international access to harmonized CLIA-, CAP- and ISO15189-compliant clinical testing and contract research services. Invivoscribe, which currently has companion diagnostics development agreements with Novartis and Astellas Pharma Inc., expects to announce other collaborations this year. Invivoscribe and its subsidiaries provide what the company considers “one-stop comprehensive care” for patients in more than 50 countries.
“Our goal and focus is to provide resources necessary so physicians can prescribe the right medication, to the right patient, in the right amount, at the right time, for the right disease,” Miller notes. “Personalized molecular medicine is gaining acceptance because it has become apparent that for many drugs and diseases, some relatively simple and cost-effective tests can stratify patients according to their disease status and genetics so they can get maximal benefit from treatment options. Personalized molecular medicine fulfills its promise when targeted therapies are coupled with molecular studies that confirm the efficacy of treatment—prior to the start of treatment. There are now a number of targeted small-molecule candidates in late stages of regulatory approval that target specific gene targets. We test these specific gene targets to confirm mutation status prior to treatment.”