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NEW YORK ─ Caris Life Sciences on Tuesday announced the submission of two premarket approval (PMA) applications to the US Food and Drug Administration for its MI Exome CDx and MI Transcriptome CDx sequencing assays.

The assays include important companion diagnostic biomarkers with therapy claims and detect all classes of alterations including genomic signatures for microsatellite instability (MSI), tumor mutation burden (TMB), and loss of heterozygosity (LOH), Irving, Texas-based Caris said.

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