Natera receives FDA breakthrough designation for multi-cancer blood test

Priority access to FDA feedback and review opened for a multi-cancer blood test on Friday after Natera, Inc. NASDAQNTRA said its assay received Breakthrough Device designation. The agency assessed data from 12 cancer types, according to the company, but the designation does not authorize the test for marketing.

In its Oct. 9 release, Natera said the assay analyzes cell-free DNA in blood to screen for different cancers. The company said the FDA considered sensitivity, specificity and cancer signal origin performance, yet the announcement supplied no numerical results or timetable for a marketing application.

Natera is an Austin, Texas-based molecular testing company with commercial businesses in oncology, women's health and organ health.

Natera shares climbed to US$403.62 on Nasdaq at 10:17:48 a.m. EDT on Friday, according to NASDAQNTRA.

FDA Offers Earlier Feedback and Priority Review

The FDA's Breakthrough Devices Program guidance says designated manufacturers can engage with agency experts as questions arise before a marketing decision. They can also expect prioritized review of a later submission. The same safety and effectiveness standards still apply, so designation by itself says nothing about the eventual decision.

The program covers devices that may qualify for premarket approval, 510(k) clearance or De Novo authorization. Natera's release did not identify which of those routes it expects to pursue for this assay. It also did not say when the company plans to submit evidence for a marketing decision.

The data gap is material for a screening test intended for people who may have no symptoms. Natera's announcement gives no study population size, sensitivity or specificity figures, false-positive rate or cancer signal origin accuracy. Those measures would help show how often the assay finds cancer and how many people without cancer might be sent for further tests.

"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," Natera corporate chief medical officer and general manager of oncology and early cancer detection Alexey Aleshin said in the release.

For now, the designation gives Natera a route to discuss those questions with the FDA while its evidence package develops. A 510(k) clearance, by comparison, is a marketing decision after the agency reviews a submission, as an earlier Mugglehead report on a cardiac diagnostic device illustrated.

Read more: HeartSciences receives FDA clearance for MyoVista wavECG without AI

GRAIL's Multi-Cancer Test Is Further Along

The closest listed comparator is GRAIL, Inc. NASDAQGRAL, whose Galleri test also looks for signals from multiple cancers in blood. GRAIL said in its Sept. 23 release that Galleri received Breakthrough Device designation in 2018 and that it submitted a premarket approval application on Jan. 29, 2026.

An FDA advisory panel voted seven to two, with one abstention, on Sept. 23 that Galleri's benefits outweigh its risks, GRAIL said. That vote is advice to the agency, which still has to decide the application. GRAIL's path shows the distinct steps between designation, a filed application and a final FDA decision, without setting a timetable for Natera.

A broader blood-testing peer is Guardant Health, Inc. NASDAQGH. In an Oct. 8 release, Guardant announced a European CE mark for Guardant360 CDx as a companion diagnostic for a defined advanced breast cancer treatment. That is a treatment-selection use in Europe, whereas Natera's newly designated assay is intended for multi-cancer screening in the United States.

Read more: Guardant Health gains European CE mark for ESR1 breast cancer test

Natera's next U.S. regulatory checkpoint is a marketing submission, but its Oct. 9 announcement assigned that step no date. The filing, if made, would put the test's performance and safety evidence before the FDA for the decision the designation has not yet made.