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Caris Life Sciences, a molecular profiling offerings provider, has received breakthrough device designation from the US Food and Drug Administration (FDA) for its MI Transcriptome companion diagnostic (CDx) test.

The whole transcriptome sequencing-based assay, which detects gene fusions in solid tumours, is meant to help identify patients who could benefit from treatment with specific targeted therapies.

It analyses RNA extracted from formalin-fixed paraffin embedded (FFPE) tumour tissue to detect all structural rearrangements classes such as fusions, deletions, inversions and duplications.

The in-vitro diagnostic test could also measure expression and splice variants in cancer patients.

FDA granted the breakthrough status to detect FGFR biomarkers including gene fusions in solid tumours.

“RNA-based sequencing analysis is emerging as the best method to detect clinically relevant fusions.”

The companion diagnostic can differentiate between various fusion types as well as fusions from other rearrangements.

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Caris Life Sciences added that the assay has the potential to find previously uncharacterised events. This is considered useful to identify patients who may have strong response to targeted therapy.

In addition, it could offer tumour profiling data for use by qualified health care professionals.

Caris Life Sciences president and chief scientific officer David Spetzler said: “RNA-based sequencing analysis is emerging as the best method to detect clinically relevant fusions.

“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.”

The company intends to file for pre-market approval of the companion diagnostic later this year.

MI Transcriptome is expected to be the first companion diagnostic to help identify patients with fusions who could be eligible for pan-cancer treatment.