April 28, 2020: “Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine announced the submission of two Pre-Market Approval (PMA) applications for MI Exome™ CDx and MI Transcriptome™ CDx to the U.S.FDA.
MI Exome™ CDx, whole exome sequencing (DNA), and MI Transcriptome™ CDx, whole transcriptome sequencing (RNA), are powerful precision medicine assays that include key 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).
“I am very excited about reaching this important regulatory milestone and further advancing our commitment to help cancer patients,” said David D. Halbert, Founder, Chairman and CEO 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, MSI, TMB and LOH.
MI Transcriptome™ CDx is a next-generation sequencing-based test that utilizes RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the qualitative detection of genomic and transcriptomic alterations.
MI Transcriptome™ CDx is a broad, multi-gene 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,” said David Spetzler, M.S., 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.”