MI Transcriptome™ Companion Diagnostic Test Designed to Detect Gene Fusions in Solid Tumors

Caris Life sciences announced to launch MI Transcriptome™ CDx (Companion Diagnostic Test) later this year. MI Transcriptome™ CDx is a next-generation sequencing-based in vitro diagnostic test that uses RNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue.

It detects all classes of structural rearrangements, including fusions, deletions, inversions, and duplications, as well as measuring expression and splice variants in patients diagnosed with cancer.

Gene fusions are genetic alterations frequently driving tumor progression and, as a result, are promising therapeutic targets for cancer patients.

MI Transcriptome™ CDx can distinguish between different fusion types and can differentiate fusions from other rearrangements. It also has the potential to discover previously uncharacterised events, which is important when identifying patients who could have strong response to targeted therapy.

The MI Transcriptome™ CDx assay can also provide additional tumor profiling data to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with cancer.

Additionally, MI Transcriptome™ CDx would be the first companion diagnostic for use in identifying patients with fusions potentially eligible for pan-cancer treatment.

Earlier this year, Caris launched the newest addition to its comprehensive genomic profiling offering, MI Transcriptome™, which enables Whole Transcriptome Sequencing (WTS).
MI Transcriptome uses the capabilities of high-throughput sequencing to gain insight into the RNA profiles of patients' tumors and builds upon Caris' offering of the most comprehensive tumor profiling approach, which assesses DNA, RNA and proteins to ensure patients receive the right therapies.

US Food and Drug Administration (FDA) has granted Breakthrough Device designation for the MI Transcriptome™ companion diagnostic (CDx) test.