FDA Grants Breakthrough Device Designation to Natera’s Multi-Cancer Early Detection Assay

The FDA has granted breakthrough device designation to Natera’s multi-cancer early detection (MCED) assay, a blood-based test that analyzes cell-free DNA (cfDNA) to screen for multiple cancers.¹

In granting the designation, the FDA assessed data from 12 cancer types and evaluated the assay’s sensitivity, specificity, and cancer signal origin (CSO) performance. Natera stated that the assay generated compelling results across these measures to support the designation. The news release did not report specific sensitivity, specificity, or CSO accuracy figures, nor did it identify the 12 cancer types or the study population from which the data were drawn.¹

Too many cancers are diagnosed after they’ve progressed, simply because limited screening options exist,” said Alexey Aleshin, MD, corporate chief medical officer and general manager of oncology and early cancer detection at Natera, in the 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.”

The FDA’s Breakthrough Devices Program is a voluntary program for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and that meet at least one additional criterion, such as representing breakthrough technology, having no approved or cleared alternatives, or offering significant advantages over existing approved or cleared alternatives.²

Designated devices are eligible for interactive communication with FDA experts during development and for prioritized review of premarket submissions, including premarket approval (PMA) applications, 510(k) clearances, and de novo requests.^1,2 The designation does not constitute FDA clearance or approval of the assay.

How does the MCED assay work?

The assay is designed to detect a cancer signal in cfDNA circulating in the blood and, when a signal is detected, to predict the tissue or organ in which the cancer likely originated via the CSO.¹ In MCED testing, CSO prediction is intended to help direct the diagnostic workup that follows a positive result. Natera develops cfDNA-based tests across oncology, women’s health, and organ health, and the MCED assay is being developed within the company’s early cancer detection program.¹

Natera’s oncology portfolio also includes Signatera, a personalized molecular residual disease (MRD) test that analyzes a patient’s tumor tissue to identify DNA markers unique to that cancer and then tracks those markers in serial blood draws.³

Where does MCED testing stand with the FDA?

No MCED test had received FDA approval as of the designation announcement. On September 23, 2026, the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted in support of the PMA application for GRAIL’s Galleri MCED test in adults aged 50 years and older.⁴ Panel members voted unanimously that the test is safe, 7 to 2 with 1 abstention that its benefits outweigh its risks, and 6 to 4 in support of its effectiveness. Advisory committee votes are not binding on the FDA, and the Galleri PMA application remained under agency review.

Natera did not disclose a timeline for a premarket submission for its MCED assay or plans for a registrational study in the news release.¹

What other early detection work is Natera pursuing?

Separately from the MCED assay, Natera is developing a blood-based colorectal cancer (CRC) screening test within its early cancer detection program. ^1,5 The company has described its early cancer detection assay as based on the detection of cancer-specific DNA methylation signatures; the MCED news release did not state whether the MCED assay uses the same approach.

In prospective case-control data previously reported by Natera, the CRC screening assay detected 95% (95% CI, 92%-99%) of CRCs overall and 92% of stage I CRCs, with a specificity of 91% (95% CI, 88%-94%).⁶ In an analysis of samples from the prospective, observational PROCEED-CRC study (NCT06620627), which collected blood from average-risk, asymptomatic individuals before screening colonoscopy, the assay demonstrated a sensitivity of 22.5% (95% CI, 15.4%-32.4%) for advanced adenomas and a specificity of 91.5% (95% CI, 88.2%-93.9%).

The CRC test is being evaluated in the prospective, observational FIND-CRC study (NCT07046585), which Natera has described as an FDA-grade validation study. The study plans to enroll 25,000 average-risk participants aged 40 years and older who are scheduled for colonoscopy, with CRC sensitivity and advanced neoplasia specificity as primary end points.^6,7

References

1. FDA grants breakthrough device designation for Natera’s multi-cancer early detection assay. News release. Natera. October 9, 2026. Accessed October 9, 2026. https://www.businesswire.com/news/home/20261009275528/en/FDA-Grants-Breakthrough-Device-Designation-for-Nateras-Multi-Cancer-Early-Detection-Assay
2. Breakthrough Devices Program. US Food and Drug Administration. Accessed October 9, 2026. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
3. Signatera personalized cancer monitoring. Natera. Accessed October 9, 2026. https://www.natera.com/info/monitor-cancer/
4. FDA MCGP panel vote backs Galleri multi-cancer early detection test. OncLive. Published September 24, 2026. Accessed October 9, 2026. https://www.onclive.com/view/fda-mcgp-panel-vote-backs-galleri-multi-cancer-early-detection-test
5. Natera announces innovation roadmap with advancements in MRD and early cancer detection. News release. Natera. January 15, 2025. Accessed October 9, 2026. https://www.businesswire.com/news/home/20250115920690/en/Natera-Announces-Innovation-Roadmap-with-Advancements-in-MRD-and-Early-Cancer-Detection
6. Natera reports strong advanced adenoma data from prospective PROCEED-CRC trial demonstrating 22.5% sensitivity and 91.5% specificity. News release. Natera. October 28, 2025. Accessed October 9, 2026. https://www.businesswire.com/news/home/20251028288969/en/Natera-Reports-Strong-Advanced-Adenoma-Data-from-Prospective-PROCEED-CRC-Trial-Demonstrating-22.5-Sensitivity-and-91.5-Specificity
7. Evaluation of the Natera colorectal cancer screening test in an average risk population (FIND-CRC). ClinicalTrials.gov. Accessed October 9, 2026. https://clinicaltrials.gov/study/NCT07046585