Invivoscribe(R) Launches Four CE-Marked NGS-Based LymphoTrack(R) Dx Assays

SAN DIEGO, CA--(Marketwired - Apr 21, 2015) - Invivoscribe Technologies, Inc. (IVS) announced today the commercial release of four CE-marked LymphoTrack^® Dx next-generation sequencing (NGS) assays used to detect T-cell receptor gamma (TRG) and immunoglobulin heavy chain (IGH) gene rearrangements. These in vitro diagnostic (IVD) test kits, validated for use with the Illumina MiSeq^® and ThermoFisher Ion PGM^™ instruments, comprise just a few of the CE-marked LymphoTrack Dx assays that Invivoscribe intends to release this year.

Every year millions of TCR and IGH gene clonality tests are performed on patient specimens to assist in the diagnosis and clinical management of hematologic malignancies. When evaluated in the proper clinical context, establishing presence or absence of clonality helps confirm or rule out the presence of neoplasms. The LymphoTrack Dx TRG Assay and LymphoTrack Dx IGH FR1 Assay kits provide clinical laboratories both the reagents and the bioinformatics tools necessary for them to identify and track clonal populations in pathologic samples in their own laboratories. These assays were validated using a variety of clinical samples, including difficult to test formalin fixed paraffin embedded (FFPE) specimens; the kits include positive and negative controls.

Invivoscribe's proprietary LymphoTrack Dx Software, which analyzes the FastQ files generated by the MiSeq or Ion PGM instruments and runs on standard Windows^® based platforms, is included with these CE-marked IVD assays. The software can analyze a million sequencing reads in approximately 90 seconds and samples tested on either platform yield concordant results. The software provides a complete bioinformatics solution, with clear, easy to interpret readouts including the V-J gene segment assignment for each clonal rearrangement and the sequence and frequency of these clones. Individual reports are generated for each sample.

"These assays and the accompanying bioinformatics software were designed to reduce the cost of NGS testing, while optimizing clinical sensitivity, laboratory workflow and technician cross-training; they provide an easy, straightforward path for testing, including data interpretation and analysis," said Invivoscribe's CSO & CEO, Jeffrey Miller, PhD. "In fact, all LymphoTrack Dx reagents and software products were designed and validated to allow multiplexing of all assays formatted for a given instrument, which allows laboratories to increase throughput on these instruments, decrease turnaround times for clinicians and patients awaiting test results, and reduce per sample sequencing costs." The kits include one-step PCR master mixes with either 12 (PGM) or 24 (MiSeq) individual indices, so when IGH and TRG assays are run simultaneously, 20 (PGM) or 44 (MiSeq) patient results can be generated with a single run (2 controls are required per assay).

Data generated by the IGH assays also provides important prognostic information for management of patients with chronic lymphocytic leukemia (CLL), as the test determines the somatic hypermutation (SHM) status, identifies stop codons and confirms presence of open reading frames, and defines V and J gene usage of tumor-associated clonal IGHV gene rearrangements. This latter capability is important, as usage of specific VH gene segments (e.g., V3-21), is associated with poor prognosis in CLL -- regardless of SHM status.

"Release of our LymphoTrack Dx assay kits is just the latest example of Invivoscribe's commitment to developing cutting edge tests that enable clinicians to identify and monitor patient- and tumor-specific biomarkers, which, in turn, allows them to more effectively personalize treatment for each patient," continued Dr. Miller. "Development, validation and release of these important assays with bioinformatics software is consistent with Invivoscribe's focus on personalized molecular medicine^®. Our goal is to help physicians deliver optimal care to every patient."

These CE-marked NGS LymphoTrack Dx assay kits are available for customers outside North America. A number of research use only (RUO) NGS LymphoTrack^® assay kits with LymphoTrack bioinformatics software are also available for customers in the research community.

About Invivoscribe Technologies, Inc.

Invivoscribe Technologies, Inc. and its affiliated companies (Genection, Inc., and the LabPMM laboratories) are the world's leading providers of molecular diagnostic testing solutions for leukemias and lymphomas. All products are manufactured in our ISO 13485 accredited GMP manufacturing facility. More than 500 institutions in 50 countries use our internationally harmonized, validated tests to identify, stratify and monitor hematologic cancers, including pharmaceutical and biotechnology companies, cancer research and treatment centers, academic hospital testing centers, and reference laboratories. Products include RUO next generation sequencing LymphoTrack assays for both Illumina and Thermo-Fisher NGS platforms, CE-marked IdentiClone® assays and PCR-based assays and controls for gene rearrangement, chromosome translocation, and gene mutation testing on capillary electrophoresis and gel based systems. Our companion diagnostic program assists pharmaceutical companies in the development of therapeutic agents and devices. Exclusive patent licenses cover the majority of our gene rearrangement and gene mutation testing products.