{"slug":"test","tag":"test","variants":["test"],"description":"Diagnostic tests and companion diagnostics recorded as products.","count":40,"kinds":{"drug":40},"related":[],"records":[{"id":"guardant360-cdx","kind":"drug","name":"Guardant360 CDx","route":"/drugs/guardant360-cdx/","status":"approved","tldr":"A blood test that reads a tumour's mutations without a tissue biopsy and is the FDA-approved gateway to several targeted drugs."},{"id":"oncomine-dx-target-test","kind":"drug","name":"Oncomine Dx Target Test","route":"/drugs/oncomine-dx-target-test/","status":"approved","tldr":"The first FDA-approved gene panel that could match one biopsy to several different lung cancer drugs at once."},{"id":"cobas-egfr-mutation-test","kind":"drug","name":"cobas EGFR Mutation Test v2","route":"/drugs/cobas-egfr-mutation-test/","status":"approved","tldr":"The lung cancer gene test that became the first blood-based companion diagnostic the FDA ever approved."},{"id":"therascreen-cdx","kind":"drug","name":"therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)","route":"/drugs/therascreen-cdx/","status":"approved","tldr":"A family of quick single-gene tests that decide who can have several bowel, lung, breast and bladder cancer drugs."},{"id":"ventana-pd-l1-sp142","kind":"drug","name":"VENTANA PD-L1 (SP142) Assay","route":"/drugs/ventana-pd-l1-sp142/","status":"approved","tldr":"The PD-L1 stain that decides who can have atezolizumab, scored on immune cells rather than tumour cells in breast cancer."},{"id":"ventana-pd-l1-sp263","kind":"drug","name":"VENTANA PD-L1 (SP263) Assay","route":"/drugs/ventana-pd-l1-sp263/","status":"approved","tldr":"The VENTANA SP263 assay is an immunohistochemistry stain that measures PD-L1 on tumour cells. Approved in 2017 alongside durvalumab in bladder cancer, it became the companion test in 2021 for adjuvant atezolizumab in resected lung cancer with PD-L1 on at least 1% of tumour cells, and it agrees closely with 22C3, so laboratories often validate it as a single platform."},{"id":"dako-pd-l1-22c3-pharmdx","kind":"drug","name":"PD-L1 IHC 22C3 pharmDx","route":"/drugs/dako-pd-l1-22c3-pharmdx/","status":"approved","tldr":"The 22C3 pharmDx assay is the PD-L1 stain tied to pembrolizumab since 2015 and the source of the combined positive score (CPS). The cut-off differs by cancer: 1% of tumour cells in lung cancer, CPS 1 in gastric, cervical and head and neck cancer, CPS 10 in oesophageal and triple-negative breast cancer, so one stain is read differently per disease."},{"id":"her2-testing-assays","kind":"drug","name":"HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH)","route":"/drugs/her2-testing-assays/","status":"approved","tldr":"The tests that grade a breast or stomach cancer's HER2 level, from the original trastuzumab test in 1998 to the new 'HER2-low' and 'ultralow' cut-offs."},{"id":"ventana-mmr-rxdx","kind":"drug","name":"VENTANA MMR RxDx Panel","route":"/drugs/ventana-mmr-rxdx/","status":"approved","tldr":"A four-stain test that shows whether a womb cancer has lost its DNA spell-checker, which makes immunotherapy likely to work."},{"id":"bracanalysis-cdx","kind":"drug","name":"BRACAnalysis CDx","route":"/drugs/bracanalysis-cdx/","status":"approved","tldr":"The inherited BRCA test that decides who can have PARP inhibitor pills for ovarian, breast, pancreatic and prostate cancer."},{"id":"mychoice-cdx","kind":"drug","name":"myChoice CDx","route":"/drugs/mychoice-cdx/","status":"approved","tldr":"A tumour test that measures DNA-repair scarring so that women with ovarian cancer beyond BRCA carriers can benefit from PARP inhibitors."},{"id":"trusight-oncology-comprehensive","kind":"drug","name":"TruSight Oncology Comprehensive","route":"/drugs/trusight-oncology-comprehensive/","status":"approved","tldr":"A large gene panel hospitals can run themselves, approved by the FDA in 2024 as a companion diagnostic for the tumour-agnostic drug larotrectinib."},{"id":"tempus-xt-cdx","kind":"drug","name":"Tempus xT CDx","route":"/drugs/tempus-xt-cdx/","status":"approved","tldr":"Tempus's tumour-and-normal gene panel, FDA-approved in 2023 as a companion test for EGFR antibodies in bowel cancer."},{"id":"caris-mi-cancer-seek","kind":"drug","name":"MI Cancer Seek","route":"/drugs/caris-mi-cancer-seek/","status":"approved","tldr":"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."},{"id":"resolution-ctdx-first","kind":"drug","name":"Resolution ctDx FIRST","route":"/drugs/resolution-ctdx-first/","status":"approved","tldr":"A blood test approved with adagrasib to find the KRAS G12C mutation in lung cancer when a tissue biopsy is not possible."},{"id":"cologuard","kind":"drug","name":"Cologuard","route":"/drugs/cologuard/","status":"approved","tldr":"A home stool test done every three years that looks for cancer DNA and hidden blood; a positive result means you need a colonoscopy."},{"id":"cologuard-plus","kind":"drug","name":"Cologuard Plus","route":"/drugs/cologuard-plus/","status":"approved","tldr":"The updated Cologuard, approved in 2024, which keeps the high cancer detection rate while causing fewer false alarms."},{"id":"simplescreen-crc","kind":"drug","name":"SimpleScreen CRC","route":"/drugs/simplescreen-crc/","status":"approved","tldr":"The second FDA-approved blood test for bowel cancer screening, from Freenome, sold by Abbott from late 2026."},{"id":"cancerguard","kind":"drug","name":"Cancerguard","route":"/drugs/cancerguard/","status":"emerging","tldr":"Exact Sciences' multi-cancer blood test, sold since 2025 as a lab test that has not been through FDA approval."},{"id":"clonoseq","kind":"drug","name":"clonoSEQ","route":"/drugs/clonoseq/","status":"approved","tldr":"A DNA test that counts leftover leukaemia, myeloma or lymphoma cells down to one in a million, used to decide whether treatment has really worked."},{"id":"guardant-reveal","kind":"drug","name":"Guardant Reveal","route":"/drugs/guardant-reveal/","status":"established","tldr":"A blood test for leftover cancer after surgery that needs no tumour sample, so results come faster than tumour-informed tests."},{"id":"radar-mrd","kind":"drug","name":"RaDaR","route":"/drugs/radar-mrd/","status":"established","tldr":"NeoGenomics' personalised blood test for tiny amounts of leftover cancer, tracking up to 48 mutations from the patient's own tumour."},{"id":"oncodetect","kind":"drug","name":"Oncodetect","route":"/drugs/oncodetect/","status":"emerging","tldr":"Exact Sciences' entry into the leftover-cancer blood test market, launched in 2025 for bowel cancer follow-up."},{"id":"prosigna","kind":"drug","name":"Prosigna (PAM50)","route":"/drugs/prosigna/","status":"approved","tldr":"A 50-gene test run in local hospital laboratories that estimates the ten-year risk of a hormone-positive breast cancer coming back."},{"id":"endopredict","kind":"drug","name":"EndoPredict","route":"/drugs/endopredict/","status":"established","tldr":"A 12-gene test that combines gene activity with tumour size and lymph nodes to say whether hormone therapy alone is enough, and whether to continue it beyond five years."},{"id":"breast-cancer-index","kind":"drug","name":"Breast Cancer Index","route":"/drugs/breast-cancer-index/","status":"established","tldr":"The only test designed to tell a woman who has finished five years of hormone therapy whether another five years is worth the side effects."},{"id":"prolaris","kind":"drug","name":"Prolaris","route":"/drugs/prolaris/","status":"established","tldr":"A gene test on a prostate biopsy that estimates how aggressive the cancer is, to help decide between active surveillance and treatment."},{"id":"oncotype-dx-gps","kind":"drug","name":"Oncotype DX Genomic Prostate Score","route":"/drugs/oncotype-dx-gps/","status":"established","tldr":"A 17-gene biopsy test that helps men with newly diagnosed low-risk prostate cancer decide whether to watch or treat."},{"id":"afirma","kind":"drug","name":"Afirma Genomic Sequencing Classifier","route":"/drugs/afirma/","status":"established","tldr":"A gene test on the needle sample from a thyroid lump that can safely call an 'uncertain' result benign and spare an operation."},{"id":"cxbladder","kind":"drug","name":"Cxbladder","route":"/drugs/cxbladder/","status":"established","tldr":"A urine test that can rule out bladder cancer in people with blood in their urine, so fewer need a camera examination of the bladder."},{"id":"urovysion","kind":"drug","name":"UroVysion Bladder Cancer Kit","route":"/drugs/urovysion/","status":"approved","tldr":"A urine test that looks for chromosome changes in shed bladder cells, approved for people with blood in the urine and for follow-up after bladder cancer."},{"id":"illuccix","kind":"drug","name":"Illuccix (kit for Ga-68 gozetotide)","route":"/drugs/illuccix/","status":"approved","tldr":"Telix's ready-to-label kit that lets any nuclear medicine department make the gallium PSMA scan for prostate cancer."},{"id":"locametz","kind":"drug","name":"Locametz (kit for Ga-68 gozetotide)","route":"/drugs/locametz/","status":"approved","tldr":"Novartis' gallium PSMA scan kit, approved the same day as Pluvicto as the test that qualifies men for that radioactive drug."},{"id":"fludeoxyglucose-f18","kind":"drug","name":"Fludeoxyglucose F-18 (FDG)","route":"/drugs/fludeoxyglucose-f18/","status":"approved","tldr":"The radioactive sugar used in almost every cancer PET scan, approved in the 1990s and made fresh each day by regional cyclotrons."},{"id":"paige-prostate","kind":"drug","name":"Paige Prostate Detect","route":"/drugs/paige-prostate/","status":"approved","tldr":"The first AI for reading biopsy slides authorised by the FDA, which points pathologists to prostate cancer they might otherwise miss."},{"id":"transpara","kind":"drug","name":"Transpara","route":"/drugs/transpara/","status":"approved","tldr":"The breast screening AI tested in Sweden's MASAI trial, where AI-supported reading found more cancers and nearly halved the radiologists' workload."},{"id":"lunit-insight-mmg","kind":"drug","name":"Lunit INSIGHT MMG","route":"/drugs/lunit-insight-mmg/","status":"approved","tldr":"A Korean AI mammography reader used in screening programmes in Sweden and Australia and cleared in the US and Europe."},{"id":"optellum-virtual-nodule-clinic","kind":"drug","name":"Optellum Virtual Nodule Clinic","route":"/drugs/optellum-virtual-nodule-clinic/","status":"approved","tldr":"The first AI cleared to estimate how likely a lung nodule on a CT scan is to be cancer, helping doctors decide who needs a biopsy and who can wait."},{"id":"icad-profound-ai","kind":"drug","name":"ProFound AI (iCAD)","route":"/drugs/icad-profound-ai/","status":"approved","tldr":"The first AI cleared for 3D mammography in the US, now part of RadNet's imaging network."},{"id":"kheiron-mia","kind":"drug","name":"Mia (Mammography Intelligent Assessment)","route":"/drugs/kheiron-mia/","status":"established","tldr":"A London-built breast screening AI trialled across NHS sites as a second reader, now folded into RadNet's DeepHealth after a 2024 acquisition."}]}