MI Cancer Seek™ has received approval from the Food and Drug Administration (FDA) as a companion diagnostic (CDx) test for both adult and pediatric patients (ages 1-22) to identify those who may benefit from treatment with targeted therapies, including one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies, according to a press release from Caris Life Sciences.
Notably, this is the first and only simultaneous whole exome sequencing– and whole transcriptome sequencing–based assay to receive FDA approval for CDx indications in the molecular profiling of solid tumors. This regulatory approval was issued on November 6, 2024.
“FDA approval of MI Cancer Seek – the first of its kind – further demonstrates Caris’ continued leadership in molecular science and our extreme focus on quality,” David Dean Halbert, chairman, founder and chief executive officer of Caris, said in the release. “We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools.”
The next-generation sequencing–based in vitro diagnostic device uses total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens. This is done in order to detect single nucleotide variants, insertions and deletions in 228 genes; microsatellite instability and tumor mutational burden in patients with previously diagnosed solid tumors; and copy number amplification in one gene in patients with breast cancer.
Glossary:
Next-generation sequencing: a parallel sequencing technology that offers ultra-high throughput, scalability and speed to determine the order of nucleotides in entire genomes.
Companion diagnostic: a test used as a companion to a therapeutic drug to determine its applicability to a specific person.
Whole exome sequencing: sequencing of all the protein-coding regions of the genome.
Whole transcriptome sequencing: sequencing of all RNA molecules that are present in a cell or tissue at a given time.
This companion diagnostic is intended to identify patients who may benefit from treatment with specific targeted therapies, in accordance with the approved therapeutic product labeling. This includes:
- PIK3CA for treatment with Piqray (alpelisib) in breast cancer
- KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4) for treatment with Vectibix (panitumumab) in colorectal cancer
- BRAF V600E for treatment with Braftovi (encorafenib) in combination with Erbitux (cetuximab) in colorectal cancer
- BRAF V600E for treatment with BRAF Inhibitors approved by FDA in melanoma
- BRAF V600E or V600K for treatment with Mekinist (trametinib) or BRAF/MEK Inhibitor combinations approved by FDA in melanoma
- EGFR exon 19 deletions and exon 21 L858R alterations for treatment with EGFR Tyrosine Kinase Inhibitors approved by FDA in non–small cell lung cancer
- Microsatellite instability for treatment with Keytruda (pembrolizumab) and Jemperli (dostarlimab-gxly) in solid tumors
- Microsatellite instability for treatment with Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) in endometrial carcinoma
Additionally, the approval is intended to provide tumor mutational profiling that can be used in accordance with oncology guidelines for patients with previously diagnosed solid malignant neoplasms.
“We are very excited to receive FDA approval for our MI Cancer Seek test. The extensive rigor with which the FDA evaluates new technology ensures patients have access to safe and effective tests,” Caris President David Spetzler, said in the press release. “The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies.”
Furthermore, the press release went on to note that DNA and RNA analysis by next-generation sequencing typically requires two separate testing processes, which may require more tissue and time. By combining whole exome sequencing and whole transcriptome sequencing, MI Cancer Seek can provide a comprehensive molecular blueprint that saves tissue without compromising results.
Reference:
Caris Life Sciences receives FDA approval for MI Cancer Seek™ as a companion diagnostic (CDx) test. News release. Caris Life Sciences. November 6, 2024.
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