{"entity":{"id":"therascreen-cdx","kind":"drug","name":"therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)","aka":[],"tldr":"A family of quick single-gene tests that decide who can have several bowel, lung, breast and bladder cancer drugs.","summary":"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.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA PMA P110030","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110030"},{"label":"Qiagen therascreen portfolio","url":"https://www.qiagen.com/us/product-categories/diagnostics-and-clinical-research/oncology"}],"tags":["test"],"related":[],"cancers":["colorectal","nsclc","breast-hr-positive","urothelial"],"sections":[],"technologies":["companion-diagnostic"],"targets":["kras","egfr","pik3ca","fgfr2","braf"],"drugs":["cetuximab","panitumumab","afatinib","alpelisib","erdafitinib","encorafenib"],"companies":["qiagen"],"institutions":[],"pathways":[],"terms":["companion-diagnostic-term"],"trials":["nct07617805"],"people":[],"bottlenecks":[],"keyPapers":["paper-karapetis-kras-cetuximab-colorectal-nejm-2008","paper-douillard-prime-panitumumab-ras-nejm-2013"],"journals":[],"dependsOn":[],"notes":["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.","Colorectal cancer: the RAS companion diagnostic family. The threshold the assays must reach is extended RAS, KRAS and NRAS exons 2, 3 and 4, because 17% of KRAS exon 2 wild-type patients carry another RAS mutation and gain nothing from an EGFR antibody (Douillard 2013, Sepulveda 2017)."],"brand":"therascreen","modality":"Real-time PCR companion diagnostic test family","mechanism":"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).","approvals":[{"region":"US","year":2012,"indication":"therascreen KRAS: cetuximab and panitumumab eligibility in metastatic colorectal cancer"},{"region":"US","year":2013,"indication":"therascreen EGFR: afatinib in EGFR-mutant NSCLC"},{"region":"US","year":2019,"indication":"therascreen PIK3CA (tissue and plasma): alpelisib in breast cancer; therascreen FGFR: erdafitinib in urothelial cancer"},{"region":"US","year":2020,"indication":"therascreen BRAF V600E: encorafenib plus cetuximab in colorectal cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/therascreen-cdx/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"},{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"},{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"},{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"}],"drug":[{"id":"afatinib","kind":"drug","name":"Afatinib","route":"/drugs/afatinib/"},{"id":"alpelisib","kind":"drug","name":"Alpelisib","route":"/drugs/alpelisib/"},{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"encorafenib","kind":"drug","name":"Encorafenib","route":"/drugs/encorafenib/"},{"id":"erdafitinib","kind":"drug","name":"Erdafitinib","route":"/drugs/erdafitinib/"},{"id":"panitumumab","kind":"drug","name":"Panitumumab","route":"/drugs/panitumumab/"}],"company":[{"id":"qiagen","kind":"company","name":"QIAGEN","route":"/companies/qiagen/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"}],"trial":[{"id":"nct07617805","kind":"trial","name":"EGFR/HER2 Dual-Target CAR-NK Cells for Recurrent or Metastatic HNSCC","route":"/trials/nct07617805/"}],"paper":[{"id":"paper-karapetis-kras-cetuximab-colorectal-nejm-2008","kind":"paper","name":"K-ras mutations and benefit from cetuximab in advanced colorectal cancer","route":"/key-papers/paper-karapetis-kras-cetuximab-colorectal-nejm-2008/"},{"id":"paper-douillard-prime-panitumumab-ras-nejm-2013","kind":"paper","name":"Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer (PRIME)","route":"/key-papers/paper-douillard-prime-panitumumab-ras-nejm-2013/"}],"biomarker":[{"id":"braf-v600e","kind":"biomarker","name":"BRAF V600E (and V600K)","route":"/biomarkers/braf-v600e/"},{"id":"egfr-exon-19-deletion","kind":"biomarker","name":"EGFR exon 19 deletion","route":"/biomarkers/egfr-exon-19-deletion/"},{"id":"fgfr3-alteration","kind":"biomarker","name":"FGFR3 alteration (mutation or fusion)","route":"/biomarkers/fgfr3-alteration/"},{"id":"kras-g12c","kind":"biomarker","name":"KRAS G12C","route":"/biomarkers/kras-g12c/"},{"id":"kras-g12d","kind":"biomarker","name":"KRAS G12D (and other non-G12C KRAS mutations)","route":"/biomarkers/kras-g12d/"},{"id":"pdgfra-exon-18-d842v","kind":"biomarker","name":"PDGFRA exon 18 mutation (D842V)","route":"/biomarkers/pdgfra-exon-18-d842v/"},{"id":"pik3ca-hotspot-mutation","kind":"biomarker","name":"PIK3CA mutation","route":"/biomarkers/pik3ca-hotspot-mutation/"},{"id":"ras-wild-type","kind":"biomarker","name":"RAS wild-type (extended KRAS and NRAS testing)","route":"/biomarkers/ras-wild-type/"}],"roadmap":[{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}