OncoFirm™ / Cancer Atlas 2026 / Emerging diagnostic technologies

Cancer Atlas 2026 · Diagnostic technologies

Emerging Cancer Diagnostic Technologies in 2026: Approved, Marketed and Research-Stage Tests

New cancer tests arrive faster than proof that they help patients. This Atlas chapter sorts the main emerging diagnostic technologies by maturity as of 1 October 2026: approved or validated, sold without FDA approval, and still in research. It also covers point-of-care fluorescent lateral flow and the regulatory backdrop.

By OncoFirm™ Scientific TeamPublished 1 Oct 2026Updated 1 Oct 2026Sources peer-reviewed, guidelines, regulators, linked

At a glance

Approved or validated

Plasma ctDNA companion diagnostics, one ctDNA MRD companion diagnostic (May 2026), a few AI pathology tools, AI-supported mammography

Marketed, not FDA approved

Multi-cancer early detection (MCED) blood tests, sold as laboratory-developed tests; Galleri decision pending

Research stage

Plasma proteomics, extracellular vesicles, breath tests, CRISPR diagnostics, spatial biology

Point of care

Quantitative fluorescent lateral flow is technically mature; independent clinical validation for tumor markers is thin

OncoFirm™ status

Assays, reader and software in development; research use only; not cleared or approved; not for sale

On this page

Key numbers

Emerging cancer diagnostics in three numbers

0multi-cancer early detection tests FDA approved as of 1 October 2026
80.5%sensitivity of AI-supported mammography reading in MASAI, versus 73.8% with standard double reading
0.33median correlation between two leading plasma proteomics platforms

Sources: FDA advisory panel reports (September 2026); MASAI trial as reported by The ASCO Post (2026); platform comparison in Nature (2023).

Maturity map

Three tiers: approved, marketed and research-stage

The word emerging can mean very different things. Some tests have passed FDA review. Some are sold today without it. Many exist only in research papers. This chapter of the OncoFirm™ Cancer Atlas 2026 sorts the main technologies into three tiers and dates every status as of 1 October 2026.

Maturity map of emerging cancer diagnostic technologies, 1 October 2026Grid of eight technologies by maturity. Approved or backed by randomized evidence: ctDNA genotyping, ctDNA MRD (approved May 2026, bladder cancer), AI digital pathology, AI-supported mammography. Marketed without FDA approval: multi-cancer blood tests sold as laboratory-developed tests, and fluorescent lateral flow tumor marker readers sold outside the United States. Research stage: proteomics, extracellular vesicles, breath and urine tests, CRISPR diagnostics and spatial biology.MATURITY MAP · STATUS AS OF 1 OCTOBER 2026ctDNA genotypingFDA-approved plasmacompanion diagnostics guidedrug choicectDNA MRDFirst blood MRD companiondiagnostic approved May 2026(bladder cancer)AI digital pathologyA few FDA-authorized slidealgorithms, mostly forprostateAI mammographyRandomized MASAI trialsupports AI-supportedreadingMCED blood testsSold as LDTs; none FDAapproved; Galleri decisionpendingFluorescent LFATumor marker readers soldoutside the US; noFDA-authorized testidentifiedProteomics, vesiclesDiscovery and earlyvalidation; platforms agreeonly modestlyBreath, urine, CRISPRWith spatial biology:research tools, not routinecancer diagnosticsTeal: FDA approved or randomized evidence. Pale: marketed without FDA approval. Orange: research stage.

Maturity map of emerging cancer diagnostic technologies as of 1 October 2026, compiled by OncoFirm™ from the FDA companion diagnostics list, trial reports and reviews in the references.

Ask two questions of any test. Has a regulator reviewed it? Is there evidence that using it improves outcomes, such as fewer deaths? A test can be authorized on accuracy data alone, and a widely sold test can lack both. For the basic vocabulary, see Cancer biomarkers explained.

Reading the labels. FDA approval and FDA clearance are marketing authorizations. A Breakthrough Device designation speeds up review; it is not an authorization. A laboratory-developed test (LDT) is designed and run in one laboratory, usually without FDA review.

Tier 1

FDA-approved tests and randomized evidence

Circulating tumor DNA (ctDNA) is tumor DNA shed into the blood. Testing it to choose a drug is established. The FDA list of companion diagnostics (tests needed to select a specific therapy) includes two plasma panels, FoundationOne Liquid CDx and Guardant360 CDx. FoundationOne Liquid CDx was first approved in August 2020; its plasma claims include EGFR mutations in non-small cell lung cancer. Our liquid biopsy guide explains the method.

Minimal residual disease (MRD) testing looks for traces of ctDNA after surgery. On 15 May 2026 the FDA approved Signatera CDx as a companion diagnostic in muscle-invasive bladder cancer, to find ctDNA-positive patients who may benefit from adjuvant atezolizumab. Its maker, Natera, calls it the first companion diagnostic approval in blood-based MRD. Elsewhere the evidence is unsettled. In stage III colon cancer, DYNAMIC-III did not meet its non-inferiority margin when chemotherapy was reduced for ctDNA-negative patients (three-year recurrence-free survival 85.3% versus 88.1%). ALTAIR found no significant benefit from treating ctDNA-positive patients after colorectal cancer surgery (hazard ratio 0.79; P=0.107). ctDNA is a strong prognostic marker, but MRD-guided treatment is proven in one setting so far.

TechnologyStatus, 1 Oct 2026Key evidenceMain limit
ctDNA genotypingFDA-approved plasma companion diagnosticsPaired with specific targeted drugsTherapy selection, not screening
ctDNA MRDOne FDA-approved companion diagnostic (bladder, May 2026)IMvigor011 phase III trialNo benefit shown yet in colorectal trials
AI digital pathologyA few FDA authorizations, mostly prostatePaige Prostate (2021), Ibex Prostate Detect (2025), ArteraAI Prostate (2025)About seven algorithms analyze whole-slide images (consultancy count)
AI-supported mammographyRandomized trial evidence (MASAI)Sensitivity 80.5% vs 73.8%; specificity 98.5% in both armsAccuracy result; no mortality data

In MASAI, more than 105,000 women in Sweden were randomized to AI-supported reading or standard double reading. Interval cancers (cancers found between screens) were 1.55 versus 1.76 per 1,000, which met the non-inferiority test. This is randomized evidence on accuracy, not yet on deaths. More in our guide to AI in cancer diagnostics and the breast cancer chapter.

Tier 2

Marketed without FDA approval: multi-cancer blood tests

Multi-cancer early detection (MCED) tests look for signals of many cancers in one blood sample. As of 1 October 2026, no MCED test is FDA approved. They are sold in the United States as LDTs.

  • Galleri (GRAIL): the company filed for premarket approval on 29 January 2026. On 23 September 2026 an FDA advisory panel voted 10–0 on safety, 6–4 on effectiveness and 7–2, with one abstention, that benefits outweigh risks. The vote does not bind the FDA. A decision is pending.
  • NHS-Galleri: this randomized trial of about 142,000 adults in England missed its primary endpoint, a reduction in combined stage III and IV diagnoses (incidence rate ratio 1.03; p=0.63). Stage IV diagnoses were 14% lower, a secondary finding. GRAIL reported 99.55% specificity and a positive predictive value of 52.0% (about half of positive results were cancers). There are no mortality data yet.
  • Cancerguard (Exact Sciences): launched on 10 September 2025 as an LDT that combines more than one class of biomarker. The company reports 64% sensitivity (excluding breast and prostate cancers) at 97.4% specificity. See multi-biomarker analysis for the caveats.
  • NCI Vanguard Study: a feasibility trial of up to 24,000 people that tests two other MCED assays. It is designed to prepare a larger outcomes trial, not to prove benefit.
Detection is not benefit. Finding cancer earlier does not prove that fewer people die. PATHFINDER 2, the other study in the Galleri application, has no control group, so it measures accuracy and safety only. See the early detection evidence hub.

Tier 3

Research-stage technologies

These approaches are in discovery or early validation. Accuracy pooled from small case-control studies tends to overstate routine performance.

  • Plasma proteomics: measuring thousands of blood proteins at once. A UK Biobank study (44,645 people, 1,463 proteins) found 618 links between proteins and cancers; 107 held in people diagnosed more than seven years after the blood draw. But two leading platforms agreed only modestly (median correlation 0.33 across 1,848 matched protein assays). A signature found on one platform needs new validation before it moves to another format.
  • Extracellular vesicles: tiny particles released by cells. One urine exosome test for prostate biopsy decisions holds a Breakthrough designation, not approval. Isolation methods are not standardized.
  • Breath tests: a 2025 meta-analysis of 125 studies pooled 87% sensitivity and 81% specificity for volatile compounds in breath. Its authors say accuracy and reliability still need validation.
  • Urine tests: MyProstateScore 2.0, an 18-gene test meant to reduce unnecessary prostate biopsies, is offered as an LDT and is not FDA approved.
  • CRISPR diagnostics: methods such as SHERLOCK and DETECTR can detect very small amounts of DNA or RNA. A 2026 review lists mostly qualitative output among the limits and names no FDA-approved CRISPR test for cancer.
  • AI on CT scans: a radiomics model found signs of pancreatic cancer on scans taken before diagnosis (sensitivity 73.0%, specificity 81.1%). The study was retrospective and awaits prospective testing.
  • Spatial biology: maps molecules inside intact tissue. In the sources reviewed for this Atlas it is a discovery tool, not a routine diagnostic.

Point of care

Point-of-care quantitative fluorescent lateral flow: evidence and limits

A lateral flow assay is a strip test. In a quantitative fluorescent version, a small reader measures light from a fluorescent label and converts it to a concentration. See how lateral flow assays work and the fluorescent lateral flow platform guide.

The format is technically mature. A 2026 review covers labels from fluorescent microspheres to quantum dots, and markers such as AFP, CEA, PSA and CA-125. It names the obstacles: matrix effects (interference from the sample itself), the hook effect (falsely low readings at very high concentrations), batch variation, weak standardization and regulatory requirements.

Reader systems with tumor marker menus are marketed outside the United States; we did not verify their regulatory status. Independent clinical validation is thin. A 2023 review of point-of-care PSA tests listed one fluorescent strip-and-reader system with a 0.1–100 ng/mL range and a 15-minute run time. The only FDA-approved device it listed (2019) was microfluidic, not a strip. Its authors found either good accuracy with narrow ranges or wide ranges with poor accuracy. Our research did not identify an FDA-authorized quantitative fluorescent lateral flow test for a tumor marker. That means none identified, not proof that none exists.

Same clinical limits. No protein tumor marker is recommended for general population cancer screening. CEA is for monitoring, PSA is an entry point to shared decisions, and AFP is used with ultrasound for surveillance in cirrhosis. A point-of-care format does not change those roles. See tumor-associated antigens.

Regulation

Regulatory backdrop: the LDT rule and IVDR

In May 2024 the FDA issued a rule to regulate LDTs as medical devices. A federal court vacated it on 31 March 2025, and the FDA removed it from its regulations effective 19 September 2025. As a result, most MCED, MRD, urine and exosome tests still reach patients through laboratories without FDA review.

Payment pulls the other way. A US law signed on 3 February 2026 creates a Medicare benefit category for MCED tests, but only after FDA approval and a coverage decision.

In the European Union, the In Vitro Diagnostic Regulation (IVDR) applies. Older devices may stay on the market until 31 December 2027 (class D), 2028 (class C) or 2029 (class B and sterile class A), if conditions such as a timely notified-body application are met.

What to watch

What to watch next

  • The FDA decision on Galleri, and mortality follow-up from NHS-Galleri.
  • Vanguard results and the design of a larger MCED outcomes trial.
  • Independent method-comparison studies of point-of-care quantitative tumor marker tests against laboratory analyzers.

OncoFirm™ roadmap

Where OncoFirm™ sits on this map

OncoFirm™ works in the point-of-care immunoassay part of this map. Its assays, reader and software are in development, are not cleared or approved by the FDA or any other regulatory authority, are for research use only and are not for sale. OncoFirm™ makes no screening or multi-cancer claims.

Quantitative CEA and PSA

Designed ranges are CEA 1–100 ng/mL and PSA 0.5–50 ng/mL, with planned traceability to WHO international standards (CEA 73/601; PSA 2nd IS 17/100). See the CEA guide.

Reader and result time

A digital reader measures the fluorescent signal. The result-time target is 20 minutes or less. This is a development target, not a validated claim.

Known limits to test

Hook effect, matrix effects and lot-to-lot calibration are the documented weak points of this format. The next evidence step is comparison with laboratory testing.

Pipeline and partners

AFP is a future pipeline candidate, and TF antigen assay concepts are concept-stage. Research groups can reach us through clinical collaborations.

OncoFirm™ assays, reader and software are in development, have not been cleared or approved by the FDA or any other regulatory authority, are for research use only and are not for sale. Designed ranges and result times are development targets, not validated performance claims.

FAQ

Frequently asked questions

Is any multi-cancer early detection blood test FDA approved?

No. As of 1 October 2026, no multi-cancer early detection test is FDA approved. An FDA advisory panel backed Galleri on 23 September 2026, but the vote is not binding and the decision is pending.

What did the NHS-Galleri trial show?

The trial randomized about 142,000 adults in England. It missed its primary endpoint, a reduction in combined stage III and IV cancer diagnoses. Stage IV diagnoses were 14% lower, a secondary finding, and no mortality results are available yet.

Is ctDNA MRD testing proven to improve treatment?

In one setting so far. On 15 May 2026 the FDA approved Signatera CDx to identify bladder cancer patients who may benefit from adjuvant atezolizumab. In colon and colorectal cancer, the DYNAMIC-III and ALTAIR trials did not show better outcomes from MRD-guided treatment changes.

Can a fluorescent lateral flow test diagnose or screen for cancer?

No. These tests measure established protein markers such as PSA or CEA, which are used for monitoring or risk assessment in defined groups, not for diagnosis on their own or for general population screening. We did not identify an FDA-authorized quantitative fluorescent lateral flow test for a tumor marker.

Does OncoFirm™ sell a cancer test?

No. OncoFirm™ assays, reader and software are in development and for research use only. They are not cleared or approved by the FDA or any other regulatory authority and are not for sale.

Sources

References

  1. U.S. Food and Drug Administration. List of Cleared or Approved Companion Diagnostic Devices. Accessed 1 October 2026. www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
  2. Natera. Signatera CDx Approved by the FDA as a Companion Diagnostic in Muscle-Invasive Bladder Cancer. Press release, May 2026. investor.natera.com/news/news-details/2026/Signatera-CDx-Approved-by-the-FDA-as-a-Companion-Diagnostic-in-Muscle-Invasive-Bladder-Cancer-MIBC/default.aspx
  3. DYNAMIC-III trial report: ctDNA-guided adjuvant chemotherapy in stage III colon cancer. Nature Medicine. 20 October 2025. www.nature.com/articles/s41591-025-04030-w
  4. ALTAIR trial report: trifluridine/tipiracil versus placebo in ctDNA-positive resected colorectal cancer. Nature Medicine. 8 June 2026. www.nature.com/articles/s41591-026-04428-0
  5. Innolitics. AI/ML in Digital Pathology and the Software as an IVD Paradigm: Snapshot. 2026. innolitics.com/articles/ai-ml-in-digital-pathology-and-the-software-as-an-ivd-paradigm-snapshot/
  6. The ASCO Post. Interval Cancer Rate With AI-Supported Mammography Screening (MASAI, The Lancet 2026). February 2026. ascopost.com/news/february-2026/interval-cancer-rate-with-ai-supported-mammography-screening/
  7. GRAIL. Full results from the NHS-Galleri trial (2026 ASCO Annual Meeting). Press release, 30 May 2026. grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/
  8. The ASCO Post. Annual Galleri Screening Reduced Stage IV Cancer Diagnoses but Missed Primary Endpoint. June 2026. ascopost.com/news/june-2026/annual-galleri-screening-reduced-stage-iv-cancer-diagnoses-but-missed-primary-endpoint-in-first-randomized-mced-trial/
  9. Targeted Oncology. Report on the FDA advisory panel votes on the Galleri multi-cancer early detection test. September 2026. www.targetedonc.com/view/fda-panel-galleri-multi-cancer-early-detection-test
  10. Exact Sciences. Launch of the Cancerguard multi-cancer early detection blood test. Press release, 10 September 2025. www.exactsciences.com/news-events/press-releases/exact-sciences-launches-cancerguard-first-of-its-kind-multi-cancer-early-detection-blood-test
  11. National Cancer Institute. Vanguard Study (Cancer Screening Research Network). prevention.cancer.gov/research-areas/networks-consortia-programs/csrn/vanguard-study
  12. Prevent Cancer Foundation. Multi-Cancer Early Detection: Coverage and Legislation. preventcancer.org/policy-advocacy/multi-cancer-early-detection/coverage-and-legislation/
  13. Papier et al. UK Biobank study of 1,463 plasma proteins and cancer risk. Nature Communications. 15 May 2024. www.nature.com/articles/s41467-024-48017-6
  14. Comparison of the Olink Explore 3072 and SomaScan v4 plasma proteomics platforms. Nature. 4 October 2023. www.nature.com/articles/s41586-023-06563-x
  15. Review of extracellular vesicle and exosome biomarkers in cancer diagnostics. Medicina. 28 October 2025. pmc.ncbi.nlm.nih.gov/articles/PMC12654841/
  16. Meta-analysis of volatile organic compound breath tests for cancer (125 studies). Clinical Biochemistry. 2025;136. www.sciencedirect.com/science/article/abs/pii/S000991202500027X
  17. National Cancer Institute. Improved Prostate Cancer Biomarker Test May Help Men Avoid Unnecessary Biopsy. 29 April 2024. prevention.cancer.gov/news-and-events/blog/improved-prostate-cancer-biomarker-test-may-help-men-avoid-unnecessary-biopsy
  18. Review of CRISPR-based diagnostics (SHERLOCK, DETECTR) in cancer. Cell & Bioscience. 2026;16:97. link.springer.com/article/10.1186/s13578-026-01603-1
  19. The ASCO Post. AI Model Enables Earlier Detection of Pancreatic Cancer on Routine CT Scans (Gut 2026). May 2026. ascopost.com/news/may-2026/ai-model-enables-earlier-detection-of-pancreatic-cancer-on-routine-ct-scans/
  20. Review of lateral flow immunoassays for tumor markers. Microchimica Acta. 2026;193:317. link.springer.com/article/10.1007/s00604-026-08051-1
  21. Review of point-of-care prostate-specific antigen tests. ACS Sensors. 13 October 2023. pmc.ncbi.nlm.nih.gov/articles/PMC10616866/
  22. Federal Register. Final rule implementing the court vacatur of the 2024 laboratory developed tests rule. 19 September 2025. www.federalregister.gov/documents/2025/09/19/2025-18239/regulation-identification-number-0910-aj05-medical-devices-laboratory-developed-tests-implementation
  23. Health Products Regulatory Authority (Ireland). IVDR Transitional Provisions. www.hpra.ie/regulation/medical-devices/manufacturers-and-authorised-representatives/ivdr-transitional-provisions

About this article. Compiled from regulator pages, peer-reviewed papers, trade reports and company releases; the NHS-Galleri, Cancerguard and Signatera CDx facts come from company releases. Part of the OncoFirm™ Cancer Atlas 2026, written by the OncoFirm™ Scientific Team from the sources linked above and reflecting public information as of 1 October 2026. It is for education and is not medical advice. OncoFirm™ has no affiliation with the companies or tests named. OncoFirm™ assays are in development, have not been cleared or approved by the FDA and are not available for sale.

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