Therapy Areas: Devices
Caris Life awarded US FDA's breakthrough device designation for MI Transcriptome companion diagnostic test to detect gene fusions across all solid tumor
6 May 2019 -

Molecular science company Caris Life Sciences reported on Friday the receipt of the US Food and Drug Administration's (FDA) breakthrough device designation for the MI Transcriptome companion diagnostic (CDx) test for detection of novel FGFR biomarkers including gene fusions in solid tumors.

With plans to submit the assay for Pre-Market Approval in late 2019, the company's CDx test is intended to assist clinicians in identifying patients who may benefit from treatment with specific targeted therapies.

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 to detect all classes of structural rearrangements, including fusions, deletions, inversions, and duplications, as well as measuring expression and splice variants in patients diagnosed with cancer. The test can distinguish between different fusion types and can differentiate fusions from other rearrangements, said the company.

The company stated gene fusions are genetic alterations frequently driving tumor progression and are promising therapeutic targets for cancer patients. It has the potential to discover previously uncharacterized events, which is important when identifying patients who could have strong response to targeted therapy.

According to the company, the MI Transcriptome CDx assay can provide additional tumor profiling data to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with cancer as well as would be the first companion diagnostic for use in identifying patients with fusions potentially eligible for pan-cancer treatment.