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Tempus's tumour-and-normal gene panel, FDA-approved in 2023 as a companion test for EGFR antibodies in bowel cancer.
The FDA approved Tempus xT CDx in 2023 as a 648-gene tumour-normal panel with a companion diagnostic claim for KRAS and NRAS wild-type colorectal cancer (cetuximab and panitumumab eligibility) and with tumour-profiling claims across solid tumours. The matched-normal design distinguishes inherited variants from tumour-acquired ones and reduces false positives. Tempus pairs the test with its multimodal database and trial-matching software, which is the company's commercial thesis: the test is the entry point to data.
1.Tempus xT CDx slips into a pocket on KRAS.
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Companion diagnostic for cetuximab and panitumumab (KRAS/NRAS wild-type colorectal cancer) with tumour-profiling claims |
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Query for this drug: (TITLE:"Tempus xT CDx" OR ABSTRACT:"Tempus xT CDx" OR TITLE:"xT CDx" OR ABSTRACT:"xT CDx") 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 Tempus xT CDx, 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 Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, Next-generation sequencing (NGS), Comprehensive genomic profiling and the tag test.
Shares RAS wild-type (extended KRAS and NRAS testing), Panitumumab, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics 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 Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, EGFR, KRAS and the tag test.
Shares Germline vs somatic mutations, Companion diagnostics, Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, EGFR and the tag test.
Shares Companion diagnostics, Next-generation sequencing (NGS), EGFR, Comprehensive genomic profiling and the tag test.