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A family of quick single-gene tests that decide who can have several bowel, lung, breast and bladder cancer drugs.
Qiagen's therascreen kits were among the first PCR companion diagnostics: therascreen KRAS RGQ (PMA P110030, 6 July 2012) identifies KRAS wild-type colorectal cancers eligible for cetuximab and panitumumab; therascreen EGFR RGQ (2013) was the companion for afatinib; therascreen PIK3CA RGQ (2019) selects alpelisib for PIK3CA-mutant, hormone-receptor-positive breast cancer from tissue or plasma; therascreen FGFR RGQ RT-PCR (2019) detects FGFR3 mutations and FGFR2/3 fusions for erdafitinib in urothelial cancer; therascreen BRAF V600E RGQ (2020) is the companion for encorafenib with cetuximab in colorectal cancer. Single-gene PCR is cheap and fast but is being displaced by panels where many genes must be checked from one small biopsy.
Scorpions and ARMS allele-specific real-time PCR kits run on the Rotor-Gene Q, each detecting a defined set of hotspot mutations or fusions from tumour tissue (and plasma for PIK3CA). Connects to KRAS, EGFR, PIK3CA / PI3K-alpha, FGFR2 and BRAF.
1.therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF) slips into a pocket on KRAS.
| Region | Year | Indication |
|---|---|---|
| US | 2012 | therascreen KRAS: cetuximab and panitumumab eligibility in metastatic colorectal cancer |
| US | 2013 | therascreen EGFR: afatinib in EGFR-mutant NSCLC |
| US | 2019 | therascreen PIK3CA (tissue and plasma): alpelisib in breast cancer; therascreen FGFR: erdafitinib in urothelial cancer |
| US | 2020 | therascreen BRAF V600E: encorafenib plus cetuximab in colorectal cancer |
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Extended RAS testing (KRAS and NRAS exons 2, 3 and 4) became the standard before any EGFR antibody, and about one in six patients who would previously have been treated is now spared a drug that would have made things worse.
It created the negative predictive biomarker in solid tumour oncology and, with the panitumumab analysis of the same year, restricted EGFR antibodies to RAS wild-type disease worldwide.
Query for this drug: (TITLE:"therascreen companion diagnostic kits" OR ABSTRACT:"therascreen companion diagnostic kits" OR TITLE:"KRAS, EGFR, PIK3CA, FGFR, BRAF" OR ABSTRACT:"KRAS, EGFR, PIK3CA, FGFR, BRAF" OR TITLE:"therascreen" OR ABSTRACT:"therascreen") 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 therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF), not a curated reading list.
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 Companion diagnostic, EGFR exon 19 deletion, KRAS G12C, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment and the tag test.
Shares Companion diagnostic, EGFR exon 19 deletion, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics and the tag test.
Shares Companion diagnostic, EGFR exon 19 deletion, Companion diagnostics, BRAF 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, KRAS, Non-small-cell lung cancer and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, HR-positive / HER2-negative breast cancer, Colorectal cancer, Non-small-cell lung cancer and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, Colorectal cancer and the tag test.