Invivoscribe® Technologies Inc., a global company with more than 20 years of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular diagnostics®, today announces the expansion of its long-term collaboration agreement with Thermo Fisher Scientific to include development and commercialization of in vitro diagnostic (IVD) assays for the Applied Biosystems® 3500 Dx Series Genetic Analyzers. The company’s previously announced agreement focuses on the development of IVD oncology tests for the Ion PGM™ Dx System.
Under terms of the expanded agreement, Invivoscribe will seek FDA approval of a FLT3 Mutation Assay, as well as clearance of a number of B- and T-cell clonality and immuno-oncology assay kits that will run on the 3500 Dx capillary electrophoresis platform. The Invivoscribe FLT3 mutation assay is a signal ratio assay that identifies both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, and identifies even large ITD mutations, which are missed using many current NGS-based assays.
FLT3 is the single most important biomarker for the stratification and prognosis of acute myeloid leukemia (AML), the most deadly form of leukemia, which is diagnosed in about 20,000 new patients each year in the U.S. and has only a 25-40 percent five-year survival rate. Invivoscribe, working under a companion diagnostic agreement with Novartis, has developed a companion diagnostic for FLT3 that is currently under FDA review for use with PKC412 (midostaurin) an investigational drug in development for adults with newly-diagnosed AML who are FLT3 mutation-positive. This investigational compound was granted a Breakthrough Therapy designation by the US FDA in early 2016. The Invivoscribe LeukoStrat® CDx FLT3 Mutation Assay would be the first molecular companion diagnostic in AML.
“This agreement allows us to move forward and provide laboratories here in the US with FDA approved and cleared kits, which will be of huge benefit to patients afflicted with hematologic disease, including lymphomas and leukemias like AML. With this agreement we can launch additional IVD assays to help healthcare providers identify, stratify, and optimize treatment for their patients with hematologic malignancies, furthering the promise of personalized molecular diagnostics and precision medicine,” said Dr. Jeffrey Miller, CSO & CEO of Invivoscribe.
The expansion of the collaboration agreement is consistent with Invivoscribe’s ongoing global initiative to develop and provide internationally-standardized molecular diagnostic assays to support precision medicine in the field of oncology. Tests and reagents currently offered by Invivoscribe include a menu of more than 40 CE-marked IVD assays that run on a number of capillary and NGS platforms. Invivoscribe’s menu of RUO and CE-marked IVD assays are used by more than 650 clinical and research laboratories across 65 countries. Invivoscribe has long embraced the value of quality systems and develops all products, including bioinformatics software, compliant with ISO 13485-design control. The company has companion diagnostics development deals with Novartis and Astellas Pharma, Inc., and expects to announce additional partnerships in 2017.
About Invivoscribe 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, cGMP manufactured PCR reagents and RUO test kits including IdentiClone®, LeukoStrat®, and LymphoTrack® Assays for biomarker, clonality, minimal residual disease (MRD), and somatic hypermutation testing. In addition, Invivoscribe provides a range of CE-marked IVDs, including LymphoTrack® Dx Assays and bioinformatic software. Invivoscribe’s clinical laboratories in the USA, Europe, and Japan provide international access to harmonized CLIA, CAP, and ISO 15189 accredited clinical testing offering NGS-based gene panels, proprietary MyInformatics® bioinformatic pipeline solutions, and CRO services for the stratification, enrollment, and monitoring of patients in international clinical trials, as well as assisting regional physicians in optimizing treatments for their patients. Additional information can be found at www.invivoscribe.com