FDA-Approved Companion Diagnostics List (Oncology), 2027 Edition

FDA-approved companion diagnostics list for oncology, 2027 edition

The FDA’s list of authorised companion diagnostic devices is one of the most used reference pages in precision oncology. Regulatory teams, pathologists and laboratory directors use it to check which test a drug label points to. Diagnostics companies use it to see who holds which biomarker, and where the gaps are.

The official page is long, organised alphabetically and mixes oncology with haemophilia gene therapy, hepatitis B and obesity tests. This guide rebuilds the oncology part of the list by technology (NGS panels, liquid biopsy, PCR, immunohistochemistry and FISH/ISH), with the manufacturer, biomarker, cancer type and linked therapies for each test. It then explains how tests get on the list, how group labelling works, and what the list tells CDx vendors about where the market is going.

As-of date: we built the tables from the FDA page “List of FDA-Authorized Companion Diagnostic Devices (In Vitro and Imaging Tools)” with a content date of 3 November 2026. The list changes several times a month, so always check the FDA companion diagnostics page and the drug label before relying on any single row.

Key takeaways

• As of 3 November 2026, the FDA list holds about 60 distinct oncology companion diagnostics across more than 220 drug and indication rows (our count of the oncology entries). No imaging tool on the list is used in oncology.
• A few platforms carry most of the claims. FoundationOne CDx, FoundationOne Liquid CDx, Guardant360 CDx, Oncomine Dx Target Test and the Agilent and Roche (Ventana) IHC assays account for more than half of the oncology rows.
• 2026 brought the first ctDNA molecular residual disease CDx (Natera’s Signatera CDx, for atezolizumab in muscle-invasive bladder cancer), a new Guardant360 Liquid CDx approval with seven drug claims, and the first IHC CDx for PTEN loss.
• Most oncology CDx reach the market through a PMA or PMA supplement approved at the same time as the drug. The list also includes a 510(k), a De Novo and two Humanitarian Device Exemptions.
• Group labelling lets one test cover a whole class of drugs, such as EGFR tyrosine kinase inhibitors or BRAF/MEK combinations, which reduces the “one drug, one test” problem for laboratories.

What the FDA list is (and what it is not)

A companion diagnostic is a test that provides information essential for the safe and effective use of a corresponding therapeutic product. The FDA’s page lists in vitro diagnostics and imaging tools that have been approved, cleared or granted with a companion diagnostic claim. It has two tables: tests indicated for specific named therapies, and tests with group labelling for a class of oncology drugs.

The list does not include complementary diagnostics, which inform a benefit-risk decision but are not required for prescribing (PD-L1 tests used with some checkpoint inhibitors are the classic examples). If you are unsure which category a test sits in, our guide to companion vs complementary diagnostics explains the definitions and how tests move between categories. The list also excludes laboratory developed tests (LDTs), even when they test for the same biomarker.

Two practical points. First, the FDA itself says the drug label should always be referenced for specific information about use of the companion diagnostic. Second, the list names the legal manufacturer, which is not always the brand most people know. Dako and Agilent appear separately, and some Roche tissue tests appear under Ventana Medical Systems.

The oncology CDx list by technology

The tables below cover every oncology test we could verify on the FDA page as of 3 November 2026. Where a platform has many claims, we show the main biomarkers and a selection of linked therapies; the FDA page lists each claim separately. Brand names are as printed on the FDA list. A few older HER2 tests are summarised in a note under the ISH table rather than given their own rows.

NGS and sequencing panels (tissue and blood)

Liquid biopsy (plasma)

PCR and other targeted molecular tests

Immunohistochemistry (IHC)

FISH and other in situ hybridisation (ISH)

Notes on the tables: older HER2 tests also on the list for Herceptin in breast cancer include INFORM HER-2/neu (Ventana), InSite Her-2/neu (BioGenex), HER2 CISH pharmDx (Dako) and SPOT-LIGHT HER2 CISH (Life Technologies), plus the cobas EGFR Mutation Test v1. Score cut-offs and exact mutation lists are on the FDA page. Where the FDA page and a manufacturer announcement differ, we followed the FDA page.

How tests get on the list

Most oncology CDx are Class III devices and reach the list through premarket approval (PMA). The first claim for a new drug is normally a new PMA approved at the same time as the drug, which the FDA calls contemporaneous approval. Later claims on the same platform arrive as PMA supplements, which is how FoundationOne CDx and Guardant360 CDx have built such long entries. Our step-by-step guide to FDA companion diagnostic approval covers the PMA modules, IDEs and review timelines.

The list shows the other routes too. The MRDx BCR-ABL Test was cleared through 510(k). The Cytocell KMT2A FISH kit for revumenib was granted through De Novo in September 2025. Two ARUP assays (KIT D816V and PDGFRB FISH, both for imatinib) hold Humanitarian Device Exemptions.

The pathway is also shifting. A final order published in August 2026 moved oncology ISH companion diagnostics into Class II (510(k)), effective September 2026. A November 2025 proposal to do the same for nucleic acid-based oncology CDx, which would cover most NGS and PCR tests, had not been finalised at the time of writing. IHC tests are not covered by either action.

For the work that comes before a submission (choosing the clinical trial assay, bridging studies and partner contracts), see our post on CDx co-development and diagnostics partnerships.

Group labelling: one test, a class of drugs

In April 2020 the FDA finalised its guidance on developing and labelling in vitro companion diagnostics for a specific group of oncology therapeutic products. Instead of naming one drug, a test can be indicated to identify patients “suitable for treatment with” any FDA-approved drug in a defined class for that indication.

The second table on the FDA page lists these claims. As of 3 November 2026 they cover two classes:

• EGFR exon 19 deletions or L858R in NSCLC, for EGFR tyrosine kinase inhibitors: cobas EGFR Mutation Test v2, FoundationOne CDx, FoundationOne Liquid CDx, ONCO/Reveal Dx Lung & Colon Cancer Assay and MI Cancer Seek.
• BRAF V600 in melanoma, for BRAF inhibitors and BRAF/MEK combinations: FoundationOne CDx, MI Cancer Seek and, since July 2026, PGDx elio tissue complete CDx.

Group claims matter commercially. A laboratory running a group-labelled test does not need a separate validated test for every new drug in the class, and the diagnostics company does not need a new supplement each time a drug in the class is approved. Large NGS panels often pair their CDx claims with a broader tumour profiling claim, which is regulated separately as a Class II device and is not itself a companion claim.

Trends in the list that matter to CDx vendors

NGS consolidation

A handful of comprehensive genomic profiling panels now carry most of the targeted-therapy claims. New entrants such as Caris (MI Cancer Seek, 2024), Illumina (TruSight Oncology Comprehensive, 2024) and PGDx (2026) show that there is still room, but each new panel must earn its claims drug by drug. For pharma, the question is less “which test?” and more “which platforms will our label name, and in how many laboratories will they run?”

Liquid biopsy moves from second option to first choice for some claims

Plasma claims now cover EGFR, KRAS G12C, HER2, ESR1, BRAF, PIK3CA, ALK, ROS1, MET and HRR genes. ESR1 in breast cancer is mainly a plasma story: the 2025 and 2026 approvals for imlunestrant, vepdegestrant and camizestrant were all linked to Guardant tests. In May 2026, Signatera CDx became the first ctDNA molecular residual disease test on the list, opening an adjuvant, monitoring-led use case that is different from therapy selection at diagnosis.

IHC keeps growing, and scoring is going digital

Antibody-drug conjugates have brought new protein targets (FOLR1, Claudin 18.2, c-Met, HER2-low and HER2-ultralow) and harder scoring rules. Roche’s VENTANA TROP2 RxDx Device, an AI-assisted computational pathology test, received FDA Breakthrough Device designation in April 2025 but was not on the list as of 3 November 2026. Expect digital pathology, image analysis and scanner vendors to be part of more CDx partnerships.

Haematology and cell therapy diagnostics

Haematology CDx are fewer but steady (IDH1, IDH2, FLT3, KMT2A, TP53 deletion). HLA typing for tebentafusp and afamitresgene autoleucel shows that cell and T-cell receptor therapies bring their own diagnostic needs.

LDTs after the 2025 court ruling

On 31 March 2025 a US District Court in Texas vacated the FDA’s 2024 final rule on laboratory developed tests, finding that the agency lacked authority to regulate LDTs as devices. The FDA did not appeal, and in September 2025 it published a rule restoring the earlier regulatory text. LDTs therefore remain outside FDA premarket review. That does not put them on the CDx list: drug labels still point to FDA-authorised tests. But in practice many patients are still tested with LDTs, and much of the commercial value of a CDx claim depends on how many laboratories adopt the kit.

How CDx vendors and sponsors can use the list

• Partner mapping: filter the list by manufacturer to see which pharma companies each diagnostics company has already delivered for. Repeat partnerships are common, and a track record on the list is a strong signal in a partner selection.
• White space by biomarker: compare the list with drug pipelines. Biomarkers with approved drugs but only one CDx, or only tissue tests, are openings for a second test or a plasma claim.
• Technology fit: if your platform is IHC, the growth is in ADC targets and digital scoring. If it is NGS, it is in group claims, plasma and MRD.
• Regulatory planning: look at which route comparable tests took. The ISH reclassification and the pending nucleic acid order may change what the next submission looks like.

Meet pharma precision medicine teams at ImmunoMark Stream 2

Every row on this list started as a conversation between a drug team and a diagnostics partner. ImmunoMark Summit’s Stream 2, Biomarkers & Companion Diagnostics, runs in parallel with the immuno-oncology stream at all three 2027 editions, and puts CDx developers, IVD manufacturers and central laboratories in front of pharma precision medicine, translational and regulatory teams.

• San Diego, 10–11 February 2027: Stream 2 includes “Market Access and Reimbursement Strategies for Companion Diagnostics in Precision Oncology” and “Global Regulatory Strategies for Companion Diagnostics and Precision Medicine”. See the San Diego companion diagnostics sponsor page.
• London, 3–4 March 2027: sessions include “Companion Diagnostics Co-development Strategies” and the panel “Global CDx Approval Pathways – EMA, FDA & MHRA Perspectives”. See the London companion diagnostics sponsor page.
• Boston, June 2027: the East Coast launch edition brings the same two-stream format to the Boston biotech cluster. See the Boston companion diagnostics sponsor page.

Sponsors and exhibitors get pre-scheduled 20-minute 1:1 meetings, a wishlist to request the people they want to meet, and the full delegate list about 10 days before the event. At the London 2026 edition, sponsors had 15–25 meetings each. To see what that could mean for your pipeline, try the sponsorship ROI calculator or compare all options on the sponsor hub.

FAQs

What is the FDA list of approved companion diagnostics?

It is a public FDA web page listing every in vitro diagnostic and imaging tool authorised with a companion diagnostic claim. Each row gives the test and manufacturer, the indication and sample type, the linked drug, the biomarker and the PMA, 510(k), De Novo or HDE number with its date. A second table lists tests with group labelling for a class of oncology drugs.

How many oncology companion diagnostics has the FDA approved?

By our count of the FDA page dated 3 November 2026, about 60 distinct oncology tests appear across more than 220 drug and indication rows, plus a separate group labelling table. Counts depend on how you treat test versions and manufacturer names, and the list changes often, so check the FDA page for the current number.

What are examples of companion diagnostics in oncology?

Well-known examples include PD-L1 IHC 22C3 pharmDx for pembrolizumab, PATHWAY anti-HER-2/neu (4B5) for trastuzumab deruxtecan in HER2-low and HER2-ultralow breast cancer, FoundationOne CDx and Oncomine Dx Target Test for targeted therapies in lung cancer, Guardant360 CDx for ESR1-targeted breast cancer drugs, and Signatera CDx for atezolizumab in muscle-invasive bladder cancer.

What is the difference between a companion and a complementary diagnostic?

A companion diagnostic is essential for the safe and effective use of the drug, so the drug label requires the test. A complementary diagnostic gives information that helps the benefit-risk decision but is not required before prescribing. Only companion diagnostics appear on the FDA list.

Can a laboratory developed test be used as a companion diagnostic?

An LDT is not an FDA-authorised companion diagnostic and does not appear on the list. After a US court vacated the FDA’s LDT rule in March 2025, LDTs remain outside FDA premarket review, and many laboratories still use them for oncology biomarker testing. Drug labels, however, refer to FDA-authorised tests.

What is group labelling for companion diagnostics?

Group labelling lets a test be indicated for a class of oncology drugs rather than a single named drug, under FDA guidance finalised in April 2020. On the current list, group claims cover EGFR tyrosine kinase inhibitors in NSCLC and BRAF inhibitors or BRAF/MEK combinations in melanoma.