Caris Life Sciences, Irving, Texas, has submitted two premarket approval (PMA) applications to FDA for MI Exome CDx and MI Transcriptome CDx. MI Exome CDx, whole exome sequencing (DNA), and MI Transcriptome CDx, whole transcriptome sequencing (RNA), are precision medicine assays that include key companion diagnostic biomarkers with therapy claims and detect all classes of alterations.

“I am very excited about reaching this important regulatory milestone and further advancing our commitment to help cancer patients,” says David D. Halbert, founder, chairman, and chief executive officer of Caris. “MI Exome CDx and MI Transcriptome CDx are incredibly sophisticated and comprehensive assays designed to identify the molecular information required to personalize care—they will represent the only clinical offering of their kind and will be run on each and every clinical patient.”

  • MI Exome CDx is a next-generation sequencing-based test utilizing DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the qualitative detection of genomic alterations. MI Exome CDx can identify genetic variants (single nucleotide variants, insertions and deletions), copy number alterations, microsatellite instability, tumor mutation burden, and loss of heterozygosity.
  • MI Transcriptome CDx is a next-generation sequencing-based test that utilizes RNA isolated from FFPE tumor tissue specimens for the qualitative detection of genomic and transcriptomic alterations. MI Transcriptome CDx is a broad, multigene panel utilized to identify gene fusions, transcript variants, genetic variants (single nucleotide variants, insertions and deletions), and gene expression changes. MI Transcriptome CDx received Breakthrough Device designation by the FDA in 2019.

“We have been very encouraged by the FDA’s support of precision oncology. They have been a great partner to work with and we look forward to continuing to work with them,” says David Spetzler, PhD, MBA, president and chief scientific officer. “MI Exome CDx and MI Transcriptome CDx will have an immediate impact for patients upon approval, and the molecular data generated from these platforms will create boundless opportunities to inform and innovate in molecular science for many years to come.”

For more information, visit Caris Life Sciences.

Featured image: David Spetzler, MBA, PhD,  Caris Life Sciences.