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Medical Devices / Submissions and Approvals

Caris Nabs Breakthrough Designation for Diagnostic Test

May 7, 2019
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The FDA handed Caris Life Sciences’ MI Transcriptome companion diagnostic test breakthrough designation, an assay the company plans to submit for premarket approval in late 2019.

The sequencing-based in vitro diagnostic test is designed to detect gene fusions in solid tumors and helps clinicians identify cancer patients who could benefit from specific targeted therapies. It is able to distinguish between different fusion types and differentiate between fusions from other rearrangements.

The assay can also produce additional tumor profiling data for use by healthcare professionals.

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