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Diagnostic tests and companion diagnostics recorded as products. 182 records carry it: 182 drugs.
| Cancers | Other tags | ||||
|---|---|---|---|---|---|
23andMe Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) A saliva test sold directly to the public that looks for a short list of known BRCA1 and BRCA2 changes. A negative result does not rule out an inherited BRCA change, because most such changes are not on the list. | Approved | none | hereditary | ||
23andMe Genetic Health Risk Report for MUTYH-Associated Polyposis 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis A saliva test sold directly to the public that looks for two common changes in the MUTYH gene, which in two copies cause an inherited bowel polyp condition. A negative result does not rule out other MUTYH changes. | Approved | none | hereditary | ||
23andMe Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) 23andMe PGS Genetic Health Risk Report for Hereditary Prostate Cancer (HOXB13-Related) A saliva test sold directly to the public that looks for one change in the HOXB13 gene, which raises a man's risk of prostate cancer. A negative result does not rule out other inherited prostate cancer risk. | Approved | none | hereditary | ||
4Kscore Test (OPKO Health) 4Kscore A blood test that estimates the chance that a biopsy would find an aggressive prostate cancer, approved by the FDA in December 2021 for men 45 and older with an abnormal PSA or examination. | Approved | Prostate cancer | screening-test | ||
Abbott RealTime IDH1 Abbott RealTime IDH1 The FDA-approved test that finds an IDH1 mutation in acute myeloid leukaemia or myelodysplastic syndrome, which makes a person eligible for an IDH1 inhibitor. | Approved | Acute myeloid leukaemia, Myelodysplastic syndromes / neoplasms | none | ||
Abbott RealTime IDH2 Abbott RealTime IDH2 The FDA-approved test that finds an IDH2 mutation in acute myeloid leukaemia, the gateway to enasidenib. | Approved | Acute myeloid leukaemia | none | ||
AccuScan AccuScan A whole-genome blood test for leftover cancer from AccuraGen that corrects sequencing errors read by read, so it can add up thousands of a tumour's mutations. | Emerging | Colorectal cancer, Oesophageal cancer, Melanoma | none | mrd | |
Adela multi-cancer methylome test Adela 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. | Emerging | none | none | mced | |
Afirma Genomic Sequencing Classifier Afirma GSC A gene test on the needle sample from a thyroid lump that can safely call an 'uncertain' result benign and spare an operation. | Established | Thyroid cancer | none | none | |
Agilent (Dako) ER and PR immunohistochemistry: ER/PR pharmDx, ER clone EP1, PR clones PgR 636 and PgR 1294 Dako ER/PR Dako's antibodies and kit for staining the oestrogen and progesterone receptors in breast cancer tissue, cleared by the FDA between 2002 and 2017; Dako is now part of Agilent. | Approved | Breast cancer, HR-positive / HER2-negative breast cancer | ihc-assay | ||
ai-CANCERCH ai-CANCERCH GC Genome's blood test from South Korea, launched in 2023 for six cancers, built on a method published with KAIST. | Emerging | none | none | mced | |
Alinity m HR HPV (Abbott) Alinity m HR HPV Abbott's laboratory HPV test, approved by the FDA in November 2023 for primary cervical screening and in 2025 for self-collected samples taken in a clinic. | Approved | Cervical cancer | screening-test | ||
Altera Altera Natera's tumour gene test, which reads every gene's DNA and RNA and can be ordered on the same sample as its Signatera blood test for recurrence. | Established | none | none | none | |
AminoIndex Cancer Screening (AICS) AminoIndex 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. | Emerging | none | none | mced | |
Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay Aptima HPV An HPV test that detects the virus's E6/E7 messenger RNA rather than its DNA, approved by the FDA in 2011, with a follow-on test that names types 16, 18 and 45. | Approved | Cervical cancer | screening-test | ||
Archer FusionPlex panels FusionPlex Laboratory kits that read tumour RNA to find gene fusions without needing to know the partner gene in advance; sold for research use, they are widely built into laboratories' own tests. | Established | none | none | rna | |
Aurora (AnchorDx) Aurora A methylation blood test for six common cancers announced by AnchorDx of Guangzhou in 2020 at a target cost of about $100; whether it reached the market could not be confirmed. | Emerging | none | none | mced | |
Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System Machines that scan Pap slides and point the human reader to the cells most likely to be abnormal, approved in the United States from 1995 onwards. | Approved | Cervical cancer | screening-test | ||
Avantect Multi-Cancer Detection Test Avantect 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. | Emerging | none | none | mced | |
BD Onclarity HPV Assay (extended genotyping) BD Onclarity HPV BD's laboratory HPV test, approved in 2018, which since 2024 names six high-risk virus types separately, helping decide who needs colposcopy, and accepts samples women take themselves. | Approved | Cervical cancer | screening-test | ||
BD SurePath liquid-based Pap test and PrepStain slide processor BD SurePath BD's liquid-based Pap test, approved in 1999 as AutoCyte PREP and renamed SurePath in 2001. | Approved | Cervical cancer | screening-test | ||
BluePrint BluePrint An 80-gene tissue test that sorts an early breast cancer into one of three biological types, used alongside MammaPrint. | Established | Breast cancer | none | rna | |
Bond Oracle HER2 IHC System Bond Oracle HER2 IHC System Leica's HER2 stain for breast cancer, listed by the FDA as a companion to trastuzumab. | Approved | HER2-positive breast cancer | none | ||
BRACAnalysis CDx BRACAnalysis CDx The inherited BRCA test that decides who can have PARP inhibitor pills for ovarian, breast, pancreatic and prostate cancer. | Approved | Ovarian cancer, HR-positive / HER2-negative breast cancer, Triple-negative breast cancer | none | ||
BRCAplus (Ambry Genetics) BRCAplus A blood test from Ambry Genetics for 13 genes linked to inherited breast cancer, including BRCA1, BRCA2, PALB2 and TP53. | Established | none | none | hereditary | |
Breast Cancer Index Breast Cancer Index (BCI) 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. | Established | HR-positive / HER2-negative breast cancer | none | none | |
brPROPHET brPROPHET Burning Rock's personalised blood test for leftover lung cancer after surgery, which tracks up to 50 of the tumour's own mutations. | Emerging | Non-small-cell lung cancer | none | mrd | |
Cancer Differentiation Analysis (CDA) CDA 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. | Emerging | none | none | mced | |
CancerDetect CancerDetect IMBdx's personalised blood test for leftover cancer, from Seoul, which adds a set of common treatable mutations to the patient's own. | Emerging | none | none | mrd | |
CancerFind CancerFind 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. | Emerging | none | none | mced | |
CancerNext and CancerNext-Expanded (Ambry Genetics) CancerNext Ambry Genetics' multi-gene blood tests for inherited cancer risk: CancerNext covers 41 genes and CancerNext-Expanded 90, ordered through a clinician. | Established | none | none | hereditary | |
CancerSEEK CancerSEEK 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. | Historic | none | none | mced | |
CancerTYPE ID CancerTYPE ID A tissue test for cancers whose starting point cannot be found that reads 92 genes to suggest which organ the cancer came from. | Established | Cancer of unknown primary | none | rna | |
Carcimun test Carcimun 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. | Emerging | none | none | mced | |
CINtec PLUS Cytology (p16/Ki-67 dual stain) CINtec PLUS A stain on cervical cells that helps decide which women with a positive HPV test need colposcopy, approved by the FDA in 2020. | Approved | Cervical cancer | screening-test | ||
clonoSEQ clonoSEQ 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. | Approved | Acute lymphoblastic leukaemia, Multiple myeloma, Chronic lymphocytic leukaemia | none | ||
cobas 4800 BRAF V600 Mutation Test cobas 4800 BRAF V600 Mutation Test The BRAF test for melanoma approved as companion to vemurafenib in 2011 and to cobimetinib with vemurafenib in 2016. | Approved | Melanoma | none | ||
cobas EGFR Mutation Test v2 cobas EGFR Mutation Test The lung cancer gene test that became the first blood-based companion diagnostic the FDA ever approved. | Approved | Non-small-cell lung cancer | none | ||
cobas HPV test (Roche) cobas HPV Roche's laboratory test for 14 high-risk HPV types, approved by the FDA for primary cervical screening and, since 2024, for samples women take themselves in a clinic. | Approved | Cervical cancer | screening-test | ||
Cologuard Cologuard A home stool test done every three years that looks for cancer DNA and hidden blood; a positive result means you need a colonoscopy. | Approved | Colorectal cancer | none | ||
Cologuard Plus Cologuard Plus The updated Cologuard, approved in 2024, which keeps the high cancer detection rate while causing fewer false alarms. | Approved | Colorectal cancer | none | ||
Color Hereditary Cancer Test Color Hereditary Cancer Test Color Health's test of 29 genes linked to inherited breast, ovarian, bowel, stomach, pancreatic, prostate and skin cancer risk. | Established | none | none | hereditary | |
CRCDx RAS Mutation Detection Assay Kit CRCdx RAS Mutation Detection A PCR test that confirms a bowel cancer has no KRAS or NRAS mutation before panitumumab. | Approved | Colorectal cancer | none | ||
Cxbladder Cxbladder Detect / Triage / Monitor 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. | Established | Bladder & urothelial cancer | none | none | |
Decipher Bladder Decipher Bladder A tissue test that sorts a bladder cancer into molecular types, which may help judge how it will respond to chemotherapy before surgery. | Established | Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer | none | rna | |
DecisionDx-Melanoma DecisionDx-Melanoma A tissue test for stage I to III skin melanoma that measures 31 genes to estimate the chance of the melanoma spreading. | Established | Melanoma | none | rna | |
DecisionDx-SCC DecisionDx-SCC A tissue test for high-risk squamous cell skin cancer that measures 40 genes to estimate the chance of spread; Medicare does not cover it. | Emerging | Cutaneous squamous cell carcinoma | none | rna | |
DecisionDx-UM DecisionDx-UM A test on a small sample of an eye melanoma that measures 15 transcripts to estimate how likely it is to spread, often to the liver. | Established | Uveal melanoma | none | rna | |
digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test hc2 High-Risk HPV DNA Test Qiagen's hybrid capture HPV test, approved by the FDA in 2003 for use with the Pap test in women 30 and older and for sorting out borderline Pap results. | Approved | Cervical cancer | screening-test | ||
Dxcover Cancer Liquid Biopsy Dxcover 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. | Emerging | Glioma & glioblastoma | none | mced | |
EGFR pharmDx Dako EGFR pharmDx Kit The 2004 EGFR protein stain approved with cetuximab for bowel cancer; the FDA database records it as withdrawn in 2024. | Withdrawn | Colorectal cancer | none | ||
Elypta GAGome multi-cancer test GAGome 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. | Emerging | none | none | mced | |
Empower Hereditary Cancer Test (Natera) Empower Natera's blood test for inherited cancer risk, offered as fixed gene panels or a gene list the clinician builds. | Established | none | none | hereditary | |
EndoPredict EndoPredict 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. | Established | HR-positive / HER2-negative breast cancer | none | none | |
Enspyre Enspyre An experimental blood test from Biofidelity in Cambridge that enriches the tumour's mutated DNA before sequencing, so it needs far less sequencing to find leftover cancer. | Emerging | Non-small-cell lung cancer | none | mrd | |
Epi proColon (Septin 9 blood test for bowel cancer) Epi proColon The first FDA-approved blood test for bowel cancer screening (2016), meant only for people who have been offered and declined the recommended screening tests. | Approved | Colorectal cancer | screening-test | ||
EpiPanGI Dx EpiPanGI Dx A research blood test that looks for six digestive-system cancers at once and predicts which organ the signal comes from. | Emerging | Colorectal cancer, Hepatocellular carcinoma, Gastric & gastro-oesophageal junction cancer | none | mced | |
ExoDx Prostate (IntelliScore) Exo mdx A urine test that reads three genes from tiny vesicles shed by the prostate to estimate the chance of a significant prostate cancer, to help decide whether a biopsy is needed. | Established | Prostate cancer | none | rna | |
Fludeoxyglucose F-18 (FDG) FDG (multiple manufacturers) The radioactive sugar used in almost every cancer PET scan, approved in the 1990s and made fresh each day by regional cyclotrons. | Approved🇺🇸🇪🇺🇬🇧 | none | none | ||
Foresight CLARITY Foresight CLARITY A blood test for leftover lymphoma that looks for several of the tumour's mutations sitting on the same piece of DNA, which lets it see far smaller traces than tests that look for one mutation at a time. | Emerging | Diffuse large B-cell lymphoma | none | mrd |
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