A tour of trial tech

TUCSON, Ariz.—HTG Molecular Diagnostics Inc. (HTG), a provider of instruments, reagents and services for molecular profiling applications, recently announced that its HTG EdgeSeq technology will be used together with Illumina next-generation sequencing in a clinical trial conducted by the Worldwide Innovative Networking Consortium (WIN) investigating a novel therapeutic approach using a combination of three targeted therapies for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Earlier, WIN announced the FDA’s approval to begin the Survival Prolongation by Rationale Innovative Genomics (SPRING) trial, which will aim to enroll NSCLC patients who are usually offered first-line platinum-based chemotherapy and who lack documented targetable driver alterations (EGFR mutations, ALK rearrangements, ROS1 and MET exon 14 skipping mutations).

“We believe HTG EdgeSeq technology will enable WIN members to measure quantitative expression of both mRNA and miRNA from the very small, challenging sample types likely to be encountered in the SPRING trial,” said TJ Johnson, HTG president and CEO.

VANCOUVER, British Columbia & SAN RAFAEL, Calif.––MedCision LLC, a provider of next-generation automated cell thawing for advanced therapies, and RepliCel Life Sciences Inc., a regenerative medicine company, announced recently that RepliCel has joined MedCision’s ThawSTAR Early Adopter Program, a novel program that helps companies and investigators de-risk thawing of cell therapies in early-stage clinical trials through to commercialization and point-of-care. Each participant will receive a ThawSTAR System on loan that is custom-engineered for their unique cell therapy product.

RepliCel intends to adopt ThawSTAR AT2 Automated Cell Thawing Systems for their Phase 2 clinical trial for skin rejuvenation (RCS-01). This NBDS Fibroblast therapy trial will address skin damage caused by aging or ultraviolet rays.

IRVING, Texas—Late August saw the Bladder Cancer Genomics Consortium (BCGC) and Hoosier Cancer Research Network announce the selection of Caris Life Sciences to perform genomic profiling for UC-GENOME, a large-scale genomically driven bladder cancer study.

The study, also known as HCRN GU15-217, is the first project of the BCGC, a collaborative effort between the Bladder Cancer Advocacy Network and major medical centers recognized for their expertise in bladder cancer. Caris will identify and report molecular aberrations via next-generation sequencing of 592 DNA genes (point mutations, copy number variations and insertions/deletions), 53 RNA gene fusions, microsatellite instability and total mutational load to aid clinicians in delivering the most optimal and personalized treatment plan for bladder cancer patients and to facilitate the development of novel therapeutics.