The Cancerguard® test: A multi-biomarker approach to cancer detection

The critical need for MCED testing

The Cancerguard test is a multi-biomarker class approach to multi-cancer early detection (MCED) testing. Currently, 66% of annual cancer cases and deaths have no recommended screening. In 2026, estimated cancer incidence in the US is ~2.1 million, with ~1.4 million estimated cancer cases having no screening recommendations. The U.S. Preventive Services Task Force (USPSTF) recommends screening for only 4 cancer types: breast, colon, lung (high risk), and cervix.

Expanding cancer detection beyond a single organ

The Cancerguard test is designed to expand cancer detection beyond a single organ. It uses a simple blood draw and is meant to complement, not replace, standard-of-care single-cancer screening. The test covers 20 organ systems, with up to 5 subtypes per system and a total of 56 cancer types and subtypes.

How the Cancerguard test works

The Cancerguard test uses ct-DNA methylation and proteins as biomarker classes. It uses curated DNA markers to better distinguish cancer from normal cells, while proteins add an independent biological signal to boost cancer detection. Combining biomarker classes expands the range of screen-detectable cancers.

Performance metrics

• The Cancerguard test has 64% overall sensitivity in the indicated population for all cancers excluding breast and prostate, with a 95% CI of 60.1%-67.8%.
• Sensitivity across 6 high mortality cancers is 68%, with a 95% CI of 62.2%-72.9%.
• Specificity is 97.4% for all cancers, with a 95% CI of 96.7%-97.9%. The test covers 20 organ systems, up to 5 subtypes per system, and a total of 56 cancer types and subtypes.

Diagnostic resolution after a positive test

The diagnostic resolution pathway after a positive test includes clinical evaluation and may include CT with contrast and 18F-FDG-PET-CT. There are no established guidelines for imaging following a positive Cancerguard test result. Physicians should use their clinical judgment and experience when deciding how to diagnose or treat patients. The test is meant to complement, not replace, standard-of-care single-cancer screening.

Care navigation and education

Flexible blood collection options include physician offices, health systems or hospitals, approved external laboratories, and at-home collection with a visiting phlebotomist.

After a positive result, care navigation services can help assess barriers to follow-up care, identify imaging locations, and coordinate follow-up appointments. For eligible patients, an imaging reimbursement program provides reimbursement of up to $6,000 for non-covered imaging costs. Eligibility depends on program qualifications and is not guaranteed.

References

Full citations supporting the clinical and scientific information presented above are included in the downloadable infographic.