FDA Grants Breakthrough Status to Multi-Cancer Early Detection Blood Test

The FDA has granted breakthrough device designation to Natera’s multi-cancer early detection (MCED) assay, an investigational blood test that analyzes cell-free DNA to screen for several cancer types from a single sample.¹

In reviewing the application, the agency evaluated data spanning 12 cancer types. The assessment weighed the assay’s sensitivity and specificity, as well as how accurately it predicts cancer signal origin (CSO). Natera characterized the results as compelling but has not publicly disclosed the performance figures that supported the designation.¹

“Too many cancers are diagnosed after they’ve progressed, simply because limited screening options exist,” Alexey Aleshin, MD, corporate chief medical officer and general manager, oncology and early cancer detection, Natera, stated in a news release. “This designation underscores the rigor and promise of our MCED program, and we look forward to working with the FDA as we aim to detect cancer earlier, when it’s easier to treat.”

What Breakthrough Status Means for the MCED Assay

The FDA reserves breakthrough device designation for novel technologies with the potential to improve the diagnosis or treatment of life-threatening or irreversibly debilitating diseases. In return, sponsors receive expedited development, assessment, and review across the premarket approval, 510(k) clearance, and De Novo marketing authorization pathways, with the goal of getting promising devices to patients and clinicians sooner.¹ The designation does not represent clearance or approval, and the MCED assay remains investigational.

Where the MCED Field Stands at the FDA

No MCED test has won FDA approval, but GRAIL’s Galleri is the furthest along in the regulatory pathway. Galleri received its own breakthrough device designation in 2018 and became the first MCED test submitted for premarket approval when GRAIL filed the final module of its application in January 2026.⁵ On September 23, 2026, the FDA’s Molecular and Clinical Genetics Devices Panel voted 7 to 2, with 1 abstention, that the test’s benefits outweigh its risks for adults aged 50 years and older. Panelists voted unanimously in favor on safety and 6 to 4 in favor on effectiveness. The agency is expected to issue a final decision in the coming months.⁶

The application drew on the PATHFINDER 2 study (NCT05155605). Among 23,161 analyzable participants, Galleri detected a cancer signal in 0.93%, with a positive predictive value of 61.6%, specificity of 99.6%, and CSO accuracy of 92%. Episode sensitivity was 40.4% across all cancers, and 53.5% of detected cancers were stage I or II.⁷ Another MCED test, Cancerguard, has been offered as a laboratory-developed test since September 2025 without FDA approval.⁸

Natera’s Colorectal Cancer Screening Program

The MCED effort sits alongside a separate, more advanced Natera program focused on colorectal cancer (CRC). That assay detects cancer-specific DNA methylation signatures in blood. In prospective case-control data shared in January 2025, it detected 95% of CRCs overall and 92% of stage I CRCs, with a specificity of 91%.²

In the prospective PROCEED-CRC trial, the CRC assay identified advanced adenomas with a sensitivity of 22.5% and a specificity of 91.5%.³

Natera is now enrolling FIND-CRC (NCT07046585), a study that aims to include 25,000 average-risk adults and is designed to capture approximately 70 CRC cases and approximately 1400 advanced adenoma cases. Approximately 24,000 patients had enrolled as of August 2026. The primary end points of the trial are CRC sensitivity and advanced neoplasia specificity. The company expects to read out FIND-CRC and submit the CRC assay to the FDA in 2027.⁴

REFERENCES

1. FDA grants breakthrough device designation for Natera’s multi-cancer early detection assay. News release. Natera, Inc. October 9, 2026. Accessed October 9, 2026. https://tinyurl.com/3yyrrvf8

2. Natera announces innovation roadmap, with advancements in MRD and early cancer detection. News release. Natera, Inc. January 15, 2025. Accessed October 9, 2026. https://tinyurl.com/bdcmayw3

3. Natera reports strong advanced adenoma data from prospective PROCEED-CRC trial demonstrating 22.5% sensitivity and 91.5% specificity. News release. Natera, Inc. October 28, 2025. Accessed October 9, 2026. https://tinyurl.com/yc6c88bk

4. Natera, Inc. Q2 2026 earnings presentation. Form 8-K, exhibit 99.2. US Securities and Exchange Commission. August 6, 2026. Accessed October 9, 2026. https://tinyurl.com/573vbfw5

5. GRAIL submits FDA premarket approval application for the Galleri multi-cancer early detection test. News release. GRAIL, Inc. January 29, 2026. Accessed October 9, 2026. https://tinyurl.com/54e77ypb

6. FDA advisory committee votes in favor of approval of GRAIL’s Galleri multi-cancer early detection test. News release. GRAIL, Inc. September 23, 2026. Accessed October 9, 2026. https://tinyurl.com/32a93dkh

7. GRAIL PATHFINDER 2 results show Galleri multi-cancer early detection blood test increased cancer detection more than seven-fold when added to USPSTF A and B recommended screenings. News release. GRAIL, Inc. October 17, 2025. Accessed October 9, 2026. https://tinyurl.com/54nufchc

8. Exact Sciences rolls out Cancerguard multi-cancer blood test. Fierce Biotech. September 11, 2025. Accessed October 9, 2026. https://tinyurl.com/kev7uf5u