Invivoscribe® Technologies Inc., an international company with decades of experience providing clonality and biomarker test solutions for the fields of oncology, personalized molecular diagnostics® and personalized molecular medicine®, announces today its long-term collaboration agreement with Illumina® Inc., to develop and commercialize in vitro diagnostic (IVD) assays for the next-generation sequencing (NGS) MiSeqDx® platform. This agreement allows Invivoscribe to bring IVD assays through the FDA, together with the associated bioinformatics software, for sale and distribution in the US.
Under the terms of the agreement, Invivoscribe will work with Illumina to seek FDA clearance or approval of a number of biomarker and immuno-oncology assay kits for use on the MiSeqDx® instrument. Invivoscribe has already developed and commercialized a number of RUO and CE-marked IVD assays for the MiSeq® instrument. These assays include a FLT3 mutation assay, a series of B- and T-cell clonality assays used to detect IGH, IGK, and TRG rearrangements, and an IGHV somatic hypermutation assay. A TRB assay kit will be released later this year. All Invivoscribe B- and T-cell clonality RUO assay kits were developed with accompanying design-controlled bioinformatics software, so customers can easily detect and track minimal residual disease (MRD) in a research setting.
Additional tests that have been developed and validated by Invivoscribe include MyAML®, MyHEME™, and MyMRD™ gene panels, as well as assays targeting other biomarker mutations. For example, the Invivoscribe FLT3 MRD mutation assay, coupled with its proprietary bioinformatics software, detects and tracks both FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations in case samples of acute myeloid leukemia (AML) to levels as sensitive as 10-6. A related assay targeting NPM1 is available as a service through Invivoscribe clinical laboratories, LabPMM, to track mutations and residual disease in AML samples.
“This agreement allows us to move forward with the opportunity to offer more than just RUO assays here in the US; it allows us to provide laboratories with internationally-standardized, FDA-approved and -cleared kits that will be of huge benefit to patients and to the field of personalized molecular diagnostics and precision medicine,” said Dr. Jeffrey Miller, Founder, CSO & CEO of Invivoscribe. “A number of these assays and associated bioinformatics software have already been validated for use at LabPMM, our CLIA/CAP, ISO 15189 accredited, New York State Licensed laboratory in San Diego. They are currently being used by leading cancer treatment centers to optimize treatment for their patients, and by pharmaceutical partners to stratify, select, and track residual disease in subjects in international phase II and phase III clinical studies. We want to make these powerful tools accessible to all of our partners and customers.”
This collaboration agreement is consistent with Invivoscribe’s ongoing global initiative to develop and provide standardized molecular diagnostic assays to support precision medicine in the oncology field. Invivoscribe’s tests and reagents include a menu of more than 40 CE-marked IVDs for use on a number of capillary electrophoresis and NGS platforms used across the world in 65 countries and in more than 650 clinical and research laboratories. Invivoscribe has long embraced the value of quality systems and develops all products, including bioinformatics software, to be compliant with ISO 13485 design control. The company has companion diagnostics development partnerships with Novartis and Astellas Pharma, Inc., and expects to announce additional collaborations in 2017.
About Invivoscribe Invivoscribe® Technologies 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 bioinformatics tools to advance the fields of personalized molecular diagnostics® and personalized molecular medicine®. Invivoscribe provides ISO 13485 certified, cGMP manufactured, PCR- and NGS-based reagents; RUO test kits; CE-marked IVDs, including IdentiClone® and LymphoTrack® Dx Assays and MyInformatics® Software; for clonality, 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 accredited clinical testing and contract research organization (CRO) services. Additional information can be found at www.invivoscribe.com.