{"slug":"test","tag":"test","variants":["test"],"description":"Diagnostic tests and companion diagnostics recorded as products.","count":65,"kinds":{"drug":65},"related":[{"slug":"mced","tag":"mced","shared":26},{"slug":"precision","tag":"precision","shared":1}],"records":[{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/","status":"phase-3","tldr":"GRAIL's blood test that looks for a signal from more than 50 cancers at once; an FDA advisory panel voted in its favour in September 2026, but in the NHS-Galleri randomised trial three yearly tests did not reduce the number of cancers found at a late stage."},{"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":"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."},{"id":"shield-mcd","kind":"drug","name":"Shield MCD (Shield Multi-Cancer Detection)","route":"/drugs/shield-mcd/","status":"emerging","tldr":"Guardant Health's blood test for ten cancers, offered in the United States as an add-on report to its bowel cancer blood test and chosen by the US National Cancer Institute for its first randomised study of such tests."},{"id":"avantect-mcd","kind":"drug","name":"Avantect Multi-Cancer Detection Test","route":"/drugs/avantect-mcd/","status":"emerging","tldr":"ClearNote Health's blood test for several cancers, one of the two tests in the US National Cancer Institute's randomised Vanguard study, with no published performance figures yet."},{"id":"harbinger-resolve","kind":"drug","name":"RESOLVE (Harbinger Health)","route":"/drugs/harbinger-resolve/","status":"emerging","tldr":"Harbinger Health's blood test meant for the weeks between a doctor suspecting cancer and a diagnosis, pointing to where in the body a cancer may be; it is not offered as a screening test for well people."},{"id":"cancerseek","kind":"drug","name":"CancerSEEK","route":"/drugs/cancerseek/","status":"historic","tldr":"The Johns Hopkins blood test that first showed one draw could find several cancers and point to the organ; its approach passed to Thrive Earlier Detection and then to Exact Sciences, whose Cancerguard test followed."},{"id":"onetest","kind":"drug","name":"OneTest for Cancer","route":"/drugs/onetest/","status":"emerging","tldr":"A low-cost blood test from 20/20 BioLabs that measures a panel of protein tumour markers and is sold in the United States as a laboratory test without FDA review."},{"id":"novelna-protein-test","kind":"drug","name":"Novelna sex-specific protein test","route":"/drugs/novelna-protein-test/","status":"emerging","tldr":"An experimental blood test that reads a handful of proteins, with different panels for men and women, to find many early cancers; so far it has been tried only on a few hundred stored samples."},{"id":"adela-mced","kind":"drug","name":"Adela multi-cancer methylome test","route":"/drugs/adela-mced/","status":"emerging","tldr":"Adela's blood test in development for 20 cancer types, built on reading DNA methylation across the whole genome; no peer-reviewed screening results yet."},{"id":"gagome-mced-test","kind":"drug","name":"Elypta GAGome multi-cancer test","route":"/drugs/gagome-mced-test/","status":"emerging","tldr":"A test in development from Elypta in Sweden that reads sugar molecules in urine and blood rather than DNA, aiming to flag many cancers including some that DNA tests find hard to see."},{"id":"carcimun-test","kind":"drug","name":"Carcimun test","route":"/drugs/carcimun-test/","status":"emerging","tldr":"A German blood test that measures how blood proteins change shape; the only studies are small, run with the inventor, and do not say how often it finds early cancers."},{"id":"dxcover-cancer-liquid-biopsy","kind":"drug","name":"Dxcover Cancer Liquid Biopsy","route":"/drugs/dxcover-cancer-liquid-biopsy/","status":"emerging","tldr":"A Glasgow company's blood test that shines infrared light through serum to look for cancer; it is sold in the UK for brain tumours, and the multi-cancer version is still in study."},{"id":"pantum-detect","kind":"drug","name":"PanTum Detect","route":"/drugs/pantum-detect/","status":"emerging","tldr":"A German blood test sold through a private health insurance add-on, which claims to signal cancer of any type; its published evidence is small studies and case reports."},{"id":"nu-q-cancer","kind":"drug","name":"Nu.Q Cancer","route":"/drugs/nu-q-cancer/","status":"emerging","tldr":"VolitionRx's blood test that measures DNA packaging released by dying cells; a version is sold for dogs, and the human multi-cancer test is at preprint stage."},{"id":"thromboseq","kind":"drug","name":"thromboSeq (tumour-educated platelet RNA)","route":"/drugs/thromboseq/","status":"emerging","tldr":"An Amsterdam research test that reads RNA inside blood platelets and detected 18 cancer types in a laboratory study, though it often flagged people with other illnesses."},{"id":"epipangi-dx","kind":"drug","name":"EpiPanGI Dx","route":"/drugs/epipangi-dx/","status":"emerging","tldr":"A research blood test that looks for six digestive-system cancers at once and predicts which organ the signal comes from."},{"id":"overc-mcdbt","kind":"drug","name":"OverC Multi-Cancer Detection Blood Test","route":"/drugs/overc-mcdbt/","status":"emerging","tldr":"Burning Rock's methylation blood test from China for five or six cancers, with Breakthrough designations from the US and Chinese regulators but no approval yet."},{"id":"panseer","kind":"drug","name":"PanSeer","route":"/drugs/panseer/","status":"emerging","tldr":"Singlera's methylation blood test, tested on stored samples from a Chinese cohort, that reported finding cancers up to four years before they were diagnosed; it has not been confirmed in a prospective study."},{"id":"oncoseek","kind":"drug","name":"OncoSeek","route":"/drugs/oncoseek/","status":"emerging","tldr":"SeekIn's low-cost protein blood test for 14 cancers, designed for countries that cannot afford DNA sequencing; it finds about six in ten cancers but flags about one in twelve people without cancer."},{"id":"seekincare","kind":"drug","name":"SeekInCare","route":"/drugs/seekincare/","status":"emerging","tldr":"SeekIn's multi-omic blood test that adds DNA sequencing to its protein test; in published studies it found about six to seven in ten cancers and about four in ten at stage I."},{"id":"spot-mas","kind":"drug","name":"SPOT-MAS","route":"/drugs/spot-mas/","status":"emerging","tldr":"Gene Solutions' low-cost blood test from Vietnam; in 9,024 people without symptoms about one in two hundred tested positive and four in ten of those had cancer."},{"id":"trucheck-intelli","kind":"drug","name":"Trucheck Intelli","route":"/drugs/trucheck-intelli/","status":"emerging","tldr":"Datar Cancer Genetics' blood test that looks for clumps of tumour cells, sold privately in the UK; the developer's marketing figures go beyond what its own papers report."},{"id":"anpac-cda","kind":"drug","name":"Cancer Differentiation Analysis (CDA)","route":"/drugs/anpac-cda/","status":"emerging","tldr":"A Chinese blood test that measures physical properties of blood rather than molecules; its developer has since turned to a different business, and the test's status is unclear."},{"id":"n-nose","kind":"drug","name":"N-NOSE","route":"/drugs/n-nose/","status":"emerging","tldr":"A Japanese urine test that uses the sense of smell of tiny worms; it is sold directly to the public in Japan, does not say which cancer, and in a real-world analysis about 2 in 100 people with a positive result were found to have cancer (about 12 in 100 after allowing for cancers the follow-up scan can miss)."},{"id":"cancerfind","kind":"drug","name":"CancerFind","route":"/drugs/cancerfind/","status":"emerging","tldr":"IMBdx's blood test from South Korea, offered at screening centres there, which in a laboratory study detected nine in ten cancers including stage I."},{"id":"ai-cancerch","kind":"drug","name":"ai-CANCERCH","route":"/drugs/ai-cancerch/","status":"emerging","tldr":"GC Genome's blood test from South Korea, launched in 2023 for six cancers, built on a method published with KAIST."},{"id":"aminoindex-cancer-screening","kind":"drug","name":"AminoIndex Cancer Screening (AICS)","route":"/drugs/aminoindex-cancer-screening/","status":"emerging","tldr":"Ajinomoto's Japanese blood test that ranks the risk of several cancers separately from amino acid levels; in a validation of 10,245 people it found 34 cancers."}]}