therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)
A family of quick single-gene tests that decide who can have several bowel, lung, breast and bladder cancer drugs.
Overview
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.
Approvals
| 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 |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: for bowel cancer, a KRAS or NRAS mutation means the EGFR antibodies will not work; for breast cancer, a PIK3CA mutation opens the door to a PI3K inhibitor.
Latest papers
topQuery 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.
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