Invivoscribe® Advances Molecular Clonality Testing Portfolio with Comprehensive LymphoTrack® Flex Suite

New ultra-high sensitivity tests enable objective, automation-ready, high-throughput clonality and MRD workflow.

SAN DIEGO--(BUSINESS WIRE)--Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, today announced the launch of the complete LymphoTrack Flex suite, an integrated next-generation sequencing (NGS) solution to identify and track immunoglobulin and T-cell receptor gene rearrangements.

As NGS-based immune receptor MRD analysis moves from academic laboratories into routine use in oncology research centers, the demand for standardized, high-throughput workflows is accelerating. Laboratories are seeking both greater efficiency and ultra-high sensitivity. This requires increasing DNA inputs while ensuring higher testing throughput and analytical performance. Translational programs need testing that is both reproducible and scalable across sites. LymphoTrack Flex meets these demands, bringing seven molecular targets (IGHV leader, IGH FR1, IGH FR2, IGH FR3, IGK, TRB and TRG), together in one automation-ready workflow with massively parallel multiplexing and a powerful bioinformatics engine to provide objective analyses and tracking of clonal sequences.

“Clonality, somatic hypermutation, and measurable residual disease provide complementary molecular insights across the course of lymphoid malignancies, with growing relevance as treatment approaches evolve beyond fixed-duration therapy toward more dynamic, MRD-informed strategies,” said Brad Patay, Chief Medical Officer of Invivoscribe. “LymphoTrack Flex enables laboratories to characterize clonal populations at baseline and select sequence-specific clonotypes for longitudinal assessments, providing a consistent molecular picture of disease over time to support the evaluation of these evolving treatment approaches.”

The software portfolio provides flexibility across laboratory environments. LymphoTrack Software supports local, desktop-based analysis for labs that want to run testing independently on a single workstation. LymphoTrack Enterprise Software provides a centralized environment for high-throughput analysis, standardized reporting, and integration with laboratory and data infrastructures, enabling labs to scale testing volume without re-architecting laboratory workflow.

“Our vision is to give all laboratories access to optimized MRD assays, controls, and analysis software, with one standardized approach,” said Jeff Miller, CEO of Invivoscribe. “I am incredibly proud of the team behind LymphoTrack Flex. This release is the result of decades of multidisciplinary and international clinical laboratory experience.”

With the complete LymphoTrack Flex suite now available, laboratories can implement a flexible, scalable NGS workflow for clonality assessment, somatic hypermutation analysis, and sequence-based MRD research across a broad range of lymphoid malignancies. Laboratories ready to expand or standardize their NGS clonality and MRD capabilities can learn more at LymphoTrack Flex page or contact [e-mail] to connect with an Invivoscribe specialist.

About Invivoscribe

Invivoscribe is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics^®. For more than thirty years, Invivoscribe has advanced the quality of healthcare worldwide by delivering high-quality, standardized reagents, diagnostic assays, sample preparation systems, and bioinformatics solutions that support precision medicine. The company has a proven track record of partnering with pharmaceutical and biotechnology organizations to support clinical trial testing through its global laboratory network in the United States, Germany, Japan, and China, as well as to develop and commercialize companion diagnostics, leveraging deep expertise in regulatory strategy and laboratory services. By offering both distributable diagnostic kits to over 700 clinical laboratory customers and clinical testing services through its globally located clinical laboratory subsidiaries, LabPMM®, Invivoscribe is an ideal partner across the full diagnostic lifecycle - from development and clinical trials through regulatory submission and commercialization.