The first FDA-approved test that sequences all of a tumour's genes and gene activity at once, used to match patients to several targeted drugs.
Caris Life Sciences' MI Cancer Seek was approved by the FDA in November 2024 as the first companion diagnostic combining whole-exome and whole-transcriptome sequencing, with claims covering several targeted and immune therapies across breast, colorectal, melanoma and lung cancers alongside tumour-profiling claims. The broad readout underpins Caris's real-world database, and the company's argument is that exome-plus-transcriptome captures fusions, expression and signatures that panels miss. Turnaround and tissue requirements are larger than for targeted panels.
Simultaneous whole-exome DNA and whole-transcriptome RNA sequencing from a single tumour sample, with companion diagnostic claims layered on top of the broad profile.
1.MI Cancer Seek slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Companion diagnostic claims across several solid tumours, with tumour-profiling claims |
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This is the fusion and immune-marker table for the wild-type minority, the group in which RNA sequencing pays for itself.
The proof of principle for multi-cancer blood tests that include pancreas; the sensitivity figures come from known cancers, not from screening.
It is the reference for what a colorectal molecular report must contain, and the document that turned extended RAS from a trial finding into a requirement.
Query for this drug: (TITLE:"MI Cancer Seek" OR ABSTRACT:"MI Cancer Seek") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about MI Cancer Seek, not a curated reading list.
Shares Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO, RAS wild-type (extended KRAS and NRAS testing), Companion diagnostics, Next-generation sequencing (NGS) and the tag test.
Shares Companion diagnostics, Next-generation sequencing (NGS), Comprehensive genomic profiling, Triple-negative breast cancer (TNBC) and the tag test.
Shares Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO, Companion diagnostics, Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma and the tag test.
Shares Companion diagnostics, Next-generation sequencing (NGS), Comprehensive genomic profiling, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer, Pancreatic ductal adenocarcinoma and the tag test.
Shares RAS wild-type (extended KRAS and NRAS testing), Companion diagnostics, HR-positive / HER2-negative breast cancer, Colorectal cancer and the tag test.
Shares Companion diagnostics, Comprehensive genomic profiling, HR-positive / HER2-negative breast cancer, Pancreatic ductal adenocarcinoma and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC), Non-small-cell lung cancer and the tag test.