Caris Life Sciences has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its MI Transcriptome companion diagnostic (CDx) test.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The MI Transcriptome CDx test has been developed for the detection of gene fusions in solid tumors. It will help clinicians to identify patients for the provision of specific targeted therapies.
The company intends to submit MI Transcriptome CDx test for pre-market approval by the end of this year.
Caris Life Sciences chief medical officer Dr Michael Korn said: “The FDA Breakthrough Device designation for the MI Transcriptome CDx assay is a significant step in advancing precision cancer care for individuals with specific genetic profiles who could benefit from targeted treatment options.”
MI Transcriptome CDx is a next-generation sequencing-based in vitro diagnostic test, which uses RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue for the detection of all classes of structural rearrangements such as fusions, deletions, inversions and duplications.
The test will also help detect measuring expression and splice variants in patients diagnosed with cancer.
The MI Transcriptome test has capacity to distinguish between different fusion types, in addition to differentiating fusions from other rearrangements.
Caris’ test can also discover previously uncharacterized events, which is helpful in identifying patients who could have better response to targeted therapy.
Through using MI Transcriptome CDx assay, the qualified health care professionals can collect additional tumor profiling data, as per the professional guidelines in oncology for patients with cancer.
The MI Transcriptome CDx is claimed to be the first companion diagnostic for use in identifying patients with fusions potentially eligible for pan-cancer treatment.
Caris president and chief scientific officer Dr David Spetzler said: “MI Transcriptome CDx, which is enabled by Whole Transcriptome Sequencing, provides information on all genes that are expressed in the cancer, which allows the most complete assessment of a patient’s tumor to inform more targeted treatment. We are delighted to have received Breakthrough Device designation and look forward to accelerating development of this assay.”