OnCo

Diagnostic tests and companion diagnostics recorded as products. 40 records carry it: 40 drugs.

40 records
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
BRACAnalysis CDx
BRACAnalysis CDx
The inherited BRCA test that decides who can have PARP inhibitor pills for ovarian, breast, pancreatic and prostate cancer.
Approved
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
Cancerguard
Cancerguard
Exact Sciences' multi-cancer blood test, sold since 2025 as a lab test that has not been through FDA approval.
Emerging
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
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
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
Cologuard Plus
Cologuard Plus
The updated Cologuard, approved in 2024, which keeps the high cancer detection rate while causing fewer false alarms.
Approved
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
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
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
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
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
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
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
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
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
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
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
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
Oncodetect
Oncodetect
Exact Sciences' entry into the leftover-cancer blood test market, launched in 2025 for bowel cancer follow-up.
Emerging
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
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
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
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
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
ProFound AI (iCAD)
ProFound Detection
The first AI cleared for 3D mammography in the US, now part of RadNet's imaging network.
Approved
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
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
RaDaR
RaDaR
NeoGenomics' personalised blood test for tiny amounts of leftover cancer, tracking up to 48 mutations from the patient's own tumour.
Established
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
SimpleScreen CRC
SimpleScreen
The second FDA-approved blood test for bowel cancer screening, from Freenome, sold by Abbott from late 2026.
Approved
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
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
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
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
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
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
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
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

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