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Caris Life Sciences Seeks FDA Approval for Exome, Transcriptome CDx Assays

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.

The companion diagnostic assays are designed to identify the molecular information required to personalize care, David Halbert, founder, chairman and CEO of Caris, said in a statement.

MI Exome CDx is a next-generation sequencing-based test that uses DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the qualitative detection of genomic alterations. The assay can identify genetic variants, including single nucleotide variants, insertions, and deletions; copy number alterations; MSI; TMB; and LOH.

MI Transcriptome CDx is an NGS test that utilizes RNA isolated from FFPE tumor tissue specimens for the qualitative detection of genomic and transcriptomic alterations. The assay is a broad, multigene panel used to identify gene fusions; transcript variants; genetic variants, including single nucleotide variants, insertions, and deletions; and gene expression changes. MI Transcriptome CDx received FDA Breakthrough Device designation in 2019, Caris noted.