Invivoscribe® Technologies Inc., a global company with decades of experience providing internationally standardized clonality and biomarker testing solutions for the fields of oncology, personalized molecular diagnostics®, and personalized molecular medicine®, reports that its next-generation sequencing (NGS) LymphoTrack® Assay kits are being used by its LabPMM® clinical laboratories, pharmaceutical partners, and cancer centers to identify and monitor chimeric antigen receptor T-cells (CAR-T) and engineered T-cell receptors in peripheral blood of subjects in support of immuno-therapeutic drug development and treatment regimen development for both hematologic and solid tumors.

Immunotherapy is one of the most exciting new areas of precision medicine. The rapidly evolving field is centered on utilizing a patient’s own immune system to surveil, target, and eliminate cancer cells. A number of immuno-therapeutic methods have demonstrated promising clinical value. In order to demonstrate clinical efficacy and move these novel therapies quickly through the regulatory agencies, accurate and standardized tests need to be employed to measure and monitor these bioengineered constructs. Leading stakeholders have turned to using Invivoscribe’s internationally standardized assays to fulfill this need.

A number of Invivoscribe LymphoTrack Assays, formatted for use on both the Illumina MiSeq® and Thermo Fisher Ion PGM™platforms, were designed to detect somatic gene rearrangements within the antigen receptor loci. These assays also recognize conserved elements within the bioengineered immuno-therapeutic constructs of CAR-T and TCRs, making them robust candidates for dual use purposes: (1) identifying and monitoring immuno-therapeutic constructs in the peripheral blood and (2) identifying and monitoring clonotypes associated with malignant B- and T-cell populations. Both capabilities can be achieved simultaneously using the same reagents, bioinformatics software, and workflow.

Once identified, these constructs and malignant clones can be tracked to levels of 1 cell in a million (10-6) sensitivity. Testing can be done either at LabPMM laboratories or entirely in an investigator’s own facility, with the bioinformatics analysis done on customer’s own computers, ensuring rapid turn around times as well as data protection.

“Our internationally standardized, NGS-based LymphoTrack clonality assays with bioinformatics software provide a comprehensive solution in support of laboratories and pharmaceutical companies developing new drugs and immuno-therapies. Having access to these powerful tools will accelerate getting new drugs and immuno-therapies to patients. As importantly, results from standardized assays generate more reproducible and reliable results, leading to better, more accurate treatments. These improved treatments will be a game changer and a huge benefit to patients and to the fields of personalized molecular diagnostics and precision medicine,” said Dr. Jeffrey Miller, Founder, CSO & CEO of Invivoscribe. “A number of our assays and associated bioinformatics software are currently being used by leading cancer centers and pharmaceutical partners in support of optimizing treatments for patients, and to stratify, enroll, and track MRD in patients in international phase II and phase III clinical studies. Our vision is to improve patient care by making these products accessible to all of our partners and customers.”

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 is ISO 13485 certified and provides PCR- and NGS-based reagents manufactured in a facility registered with FDA. Reagents include RUO test kits and CE-marked IVDs, including IdentiClone® and LymphoTrack® Dx Assays with LymphoTrack® Dx Software. LymphoTrack Dx Assays are CE-IVDs for clonality and IGHV somatic hypermutation testing and are not available for sale or use in North America. LymphoTrack Assays and MRD and immuno-therapeutic applications are for research use only. Not for use in diagnostic procedures – US validations are on-going. Invivoscribe also offers comprehensive MyAML®, MyHEME®, MyMRD®, and custom gene panel services. Used in combination with Invivoscribe’s proprietary MyInformatics® Software these assays identify and can track primary driver mutations as well as the subclonal architecture and emergence of new driver mutations in patients with hematologic disease. Invivoscribe’s clinical laboratories in the USA, Europe, and Japan provide international access to standardized CLIA, CAP, and ISO 15189 accredited clinical testing and contract research organization (CRO) services. Invivoscribe services and reagents are currently used in more than 650 clinical and research laboratories in 65 countries and Invivoscribe has long embraced the value of quality systems and develops all products, including bioinformatics software, compliant with ISO 13485 design control. This model makes the assays eligible to be brought through regulatory authorities worldwide. The company currently has on-going companion diagnostic partnerships with Novartis and Astellas Pharma, Inc. and expects to announce additional collaborations in 2017.  Additional information can be found at www.invivoscribe.com.