Invivoscribe® Technologies, Inc., a global company that provides international access to personalized molecular diagnostics, today announces it has signed a long-term strategic collaboration agreement with Thermo Fisher Scientific to develop multiple next-generation sequencing (NGS)-based, in vitro diagnostic (IVD) oncology tests on the Ion PGMTM Dx System.
Under terms of the agreement, Invivoscribe will leverage its more than two decades of development, validation and commercialization experience to manufacture and commercialize immuno-oncology molecular diagnostics and associated bioinformatics software for application in liquid biopsies. The assays may become powerful tools for diagnosis and minimal residual disease (MRD) monitoring of the full range of hematologic malignancies.
The collaboration is consistent with Invivoscribe’s ongoing global initiative to develop and provide internationally standardized, regulatory-compliant molecular diagnostic assays to support precision medicine in oncology. Invivoscribe’s test menu is used by more than 600 institutional customers in 65 countries and the company currently sells a number of CE- marked IVD assays for NGS.
“As the world leader in serving science, 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.”
“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,” said Dr. Jeffrey Miller, CEO of Invivoscribe. “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.”
Invivoscribe has long embraced the value of quality systems and develops all products consistent with ISO 13485 design control. The company has companion diagnostics development deals with Novartis and Astellas Pharma, Inc., and it expects to announce additional companion diagnostic deals in 2016.
Invivoscribe, Inc. is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, reliable, cutting-edge reagents, tests, and bioinformatic tools to advance the fields of personalized molecular diagnostics and personalized molecular medicine. Invivoscribe provides ISO 13485 certified GMP manufactured PCR- and NGS-based reagents, RUO test kits, CE-marked IVDs, including
IdentiClone®, LymphoTrack® and LymphoTrack® Dx assays for clonal, MRD, and somatic hypermutation testing. Invivoscribe’s clinical laboratories in the USA, Europe and Japan provide international access to harmonized CLIA, CAP and ISO 15189 compliant clinical testing and CRO services. Additional information can be found at www.invivoscribe.com