test
Diagnostic tests and companion diagnostics recorded as products. 40 records carry it: 40 drugs.
40 records
| Cancers | Other tags | ||||
|---|---|---|---|---|---|
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 | |
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 | ||
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 | |
Cancerguard Cancerguard Exact Sciences' multi-cancer blood test, sold since 2025 as a lab test that has not been through FDA approval. | Emerging | none | none | none | |
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 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 | ||
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 | ||
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 | |
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 | |
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 | ||
Guardant Reveal Guardant Reveal A blood test for leftover cancer after surgery that needs no tumour sample, so results come faster than tumour-informed tests. | Established | Colorectal cancer, HR-positive / HER2-negative breast cancer, Non-small-cell lung cancer | none | none | |
Guardant360 CDx Guardant360 CDx A blood test that reads a tumour's mutations without a tissue biopsy and is the FDA-approved gateway to several targeted drugs. | Approved | Non-small-cell lung cancer, HR-positive / HER2-negative breast cancer | none | ||
HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH) HercepTest / PATHWAY anti-HER2 (4B5) / INFORM HER2 Dual ISH 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. | Approved | HER2-positive breast cancer, HR-positive / HER2-negative breast cancer, Gastric & gastro-oesophageal junction cancer | none | ||
Illuccix (kit for Ga-68 gozetotide) Illuccix / Gozellix Telix's ready-to-label kit that lets any nuclear medicine department make the gallium PSMA scan for prostate cancer. | Approved | Prostate cancer | none | ||
Locametz (kit for Ga-68 gozetotide) Locametz Novartis' gallium PSMA scan kit, approved the same day as Pluvicto as the test that qualifies men for that radioactive drug. | Approved | Prostate cancer | none | ||
Lunit INSIGHT MMG Lunit INSIGHT MMG A Korean AI mammography reader used in screening programmes in Sweden and Australia and cleared in the US and Europe. | Approved | HR-positive / HER2-negative breast cancer, Triple-negative breast cancer | none | ||
MI Cancer Seek MI Cancer Seek 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. | Approved | Colorectal cancer, Non-small-cell lung cancer, Melanoma | none | ||
Mia (Mammography Intelligent Assessment) Mia A London-built breast screening AI trialled across NHS sites as a second reader, now folded into RadNet's DeepHealth after a 2024 acquisition. | Established | HR-positive / HER2-negative breast cancer, Triple-negative breast cancer | none | ||
myChoice CDx myChoice CDx A tumour test that measures DNA-repair scarring so that women with ovarian cancer beyond BRCA carriers can benefit from PARP inhibitors. | Approved | Ovarian cancer | none | ||
Oncodetect Oncodetect Exact Sciences' entry into the leftover-cancer blood test market, launched in 2025 for bowel cancer follow-up. | Emerging | Colorectal cancer | none | none | |
Oncomine Dx Target Test Oncomine Dx Target Test The first FDA-approved gene panel that could match one biopsy to several different lung cancer drugs at once. | Approved | Non-small-cell lung cancer, Biliary tract cancer | none | ||
Oncotype DX Genomic Prostate Score Oncotype DX GPS A 17-gene biopsy test that helps men with newly diagnosed low-risk prostate cancer decide whether to watch or treat. | Established | Prostate cancer | none | none | |
Optellum Virtual Nodule Clinic Virtual Nodule Clinic 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. | Approved | Non-small-cell lung cancer | none | ||
Paige Prostate Detect Paige Prostate The first AI for reading biopsy slides authorised by the FDA, which points pathologists to prostate cancer they might otherwise miss. | Approved | Prostate cancer | none | ||
PD-L1 IHC 22C3 pharmDx PD-L1 IHC 22C3 pharmDx 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. | Approved | Non-small-cell lung cancer, Gastric & gastro-oesophageal junction cancer, Cervical cancer | none | ||
ProFound AI (iCAD) ProFound Detection The first AI cleared for 3D mammography in the US, now part of RadNet's imaging network. | Approved | HR-positive / HER2-negative breast cancer, Triple-negative breast cancer | none | ||
Prolaris Prolaris A gene test on a prostate biopsy that estimates how aggressive the cancer is, to help decide between active surveillance and treatment. | Established | Prostate cancer | none | none | |
Prosigna (PAM50) Prosigna A 50-gene test run in local hospital laboratories that estimates the ten-year risk of a hormone-positive breast cancer coming back. | Approved | HR-positive / HER2-negative breast cancer | none | ||
RaDaR RaDaR NeoGenomics' personalised blood test for tiny amounts of leftover cancer, tracking up to 48 mutations from the patient's own tumour. | Established | Head and neck squamous cell carcinoma, Non-small-cell lung cancer, HR-positive / HER2-negative breast cancer | none | none | |
Resolution ctDx FIRST Resolution ctDx FIRST A blood test approved with adagrasib to find the KRAS G12C mutation in lung cancer when a tissue biopsy is not possible. | Approved | Non-small-cell lung cancer | none | ||
SimpleScreen CRC SimpleScreen The second FDA-approved blood test for bowel cancer screening, from Freenome, sold by Abbott from late 2026. | Approved | Colorectal cancer | none | ||
Tempus xT CDx xT CDx Tempus's tumour-and-normal gene panel, FDA-approved in 2023 as a companion test for EGFR antibodies in bowel cancer. | Approved | Colorectal cancer | none | ||
therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF) therascreen A family of quick single-gene tests that decide who can have several bowel, lung, breast and bladder cancer drugs. | Approved | Colorectal cancer, Non-small-cell lung cancer, HR-positive / HER2-negative breast cancer | none | ||
Transpara Transpara The breast screening AI tested in Sweden's MASAI trial, where AI-supported reading found more cancers and nearly halved the radiologists' workload. | Approved | HR-positive / HER2-negative breast cancer, HER2-positive breast cancer, Triple-negative breast cancer | none | ||
TruSight Oncology Comprehensive TSO Comprehensive A large gene panel hospitals can run themselves, approved by the FDA in 2024 as a companion diagnostic for the tumour-agnostic drug larotrectinib. | Approved | none | none | ||
UroVysion Bladder Cancer Kit UroVysion 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. | Approved | Bladder & urothelial cancer | none | ||
VENTANA MMR RxDx Panel VENTANA MMR RxDx A four-stain test that shows whether a womb cancer has lost its DNA spell-checker, which makes immunotherapy likely to work. | Approved | Endometrial cancer, Colorectal cancer | none | ||
VENTANA PD-L1 (SP142) Assay VENTANA PD-L1 (SP142) The PD-L1 stain that decides who can have atezolizumab, scored on immune cells rather than tumour cells in breast cancer. | Approved | Bladder & urothelial cancer, Non-small-cell lung cancer, Triple-negative breast cancer | none | ||
VENTANA PD-L1 (SP263) Assay VENTANA PD-L1 (SP263) 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. | Approved | Bladder & urothelial cancer, Non-small-cell lung cancer | none |