The US Food and Drug Administration (FDA) has given Natera’s blood test for detecting several cancers early a Breakthrough Device designation, the company said1. The status is meant for new technologies that could diagnose or treat life-threatening or seriously disabling diseases more effectively2. It gives Natera earlier access to FDA advice and a faster review if it files for approval. It does not approve the test or allow it to be sold1.
Natera announced the designation on October 91. It repeated the news in a LinkedIn post that OncoDaily reported on October 282.
What happened
Natera calls its product a multi-cancer early detection test. It looks at cell-free DNA, which means small loose pieces of DNA floating in the blood, to screen for several types of cancer at once2. The idea is to catch cancers before they cause symptoms, including cancers that have no routine screening test today.
According to the company, the FDA looked at data covering 12 cancer types. It weighed three measures: sensitivity, specificity and cancer signal origin1. In plain words, these are how often the test finds a cancer that is there, how often it correctly gives the all-clear to people who do not have cancer, and how well it points to where in the body a cancer may be.
Alexey Aleshin is Natera’s chief medical officer and the general manager of its oncology and early cancer detection business. He said in the company’s 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.”1
Jordan Stricker is Natera’s director of strategic oncology collaborations. He wrote on LinkedIn that “That is not a marketing authorization.” He said it means development, assessment and review “now move on a faster path”3.
The evidence so far
The only evidence made public so far is the designation itself and Natera’s description of the data behind it. The company says the test “generated compelling results” on all three measures, in Stricker’s words3. But Natera’s announcement gave no numbers. Mugglehead noted that it did not give the size of the study group, the sensitivity or specificity figures, the false-positive rate, or how accurately the test points to a cancer’s origin1.
Those numbers matter a great deal for a test meant for people who feel healthy. They would show how often the test catches cancer, and how many people without cancer might be sent for more tests after a false alarm1.
Stricker described why the origin measure matters. “A signal without a credible origin sends patients into the wrong workup,” he wrote, meaning doctors would not know where to look next3.
What the designation does not show
Under FDA guidance for the Breakthrough Devices Program, companies with the designation can talk with agency experts as questions come up, before any decision on sale. They can also expect their later application to be reviewed sooner. The same safety and effectiveness standards still apply, so the designation says nothing about what the FDA will finally decide1.
Several things are still unknown:
- Which approval route Natera will take. The program covers devices that may go through full premarket approval, a 510(k) clearance or a De Novo authorization. Natera’s release did not say which it plans to use1.
- When it will file. The company gave no date for submitting evidence to the FDA1.
- How well it performs. No accuracy figures or study details have been released publicly1.
Biohack has not seen a peer-reviewed paper or a public study record describing the data the FDA reviewed. None was cited in the sources available for this article.
Who is behind it
Natera is a molecular testing company based in Austin, Texas. It sells tests in cancer care, women’s health and organ health1. Both people quoted above work for Natera, and the main account of the data comes from the company itself. Natera is listed on the Nasdaq stock exchange, and its shares rose on the morning of the announcement1.
This is not Natera’s first Breakthrough Device designation. In 2019 the FDA gave the same status to its Signatera test. Signatera measures tumor DNA in the blood of people already diagnosed with certain cancers, after surgery4. That designation was meant to speed the FDA’s review of Signatera for use in drug trials4. Signatera tracks cancer in patients who already have a diagnosis. The new test aims to screen people who have not been diagnosed. Stricker described the new program as extending Natera’s work “reading trace signals in blood” into screening3.
How it fits the field
Natera’s closest listed competitor is Grail, whose Galleri test also looks for signals from several cancers in a blood sample1. Galleri is much further along. Grail said Galleri received its own Breakthrough Device designation in 2018 and that the company filed for full FDA approval on January 29, 20261.
On September 23, an FDA advisory panel voted 7 to 2, with one abstention, that Galleri’s benefits outweigh its risks, according to Grail1. That vote is advice to the FDA, which still has to make its own decision1. Grail’s path shows the separate steps between a designation, a filed application and a final decision. Grail took about eight years to go from designation to a filed application, but its path sets no timetable for Natera1.
Other blood-test companies are active too, though not always in screening. Guardant Health announced a European approval mark on October 8 for a test that helps choose a treatment in advanced breast cancer. That is a different use from Natera’s screening test, and in a different market1.
| Natera’s test | Grail’s Galleri | |
|---|---|---|
| Breakthrough Device designation | 20261 | 20181 |
| Filed for FDA approval | No date given1 | January 29, 20261 |
| FDA advisory panel | None | Voted 7 to 2 that benefits outweigh risks1 |
| Final FDA decision | Not yet sought | Pending1 |
What to watch next
The next regulatory step for Natera in the US is filing for permission to sell the test. Its October 9 announcement gave no date for that1. A filing would put the test’s performance and safety evidence in front of the FDA for the decision the designation has not made1.
Before then, the main thing to look for is data. Readers can watch for numbers on how often the test finds cancer, how often it raises false alarms, and how well it points to the right organ, ideally published so outside experts can check them. The outcome of the FDA’s decision on Galleri will also show how the agency treats this new kind of screening test, which could shape the path for Natera and others.
