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Natera Eyes Regulatory Path for Signatera as Companion Diagnostic

SAN FRANCISCO – Speaking at the JP Morgan Healthcare Conference here on Tuesday, Natera CEO Steve Chapman provided some clarity on the firm’s plan to take its Signatera test through the regulatory process in the US. 

The liquid biopsy test, which identifies circulating tumor DNA, was launched in 2017, and the company has been building evidence over the years for its use in a variety of cancers. 

The firm has been asked in the past about its plans to potentially take Signatera through the US Food and Drug Administration process for marketing clearance. Chapman addressed this question during the Q&A portion of his presentation at the conference, saying, "When we said IVD, we didn’t necessarily mean distributed kits." Rather, the firm needs the test to have a certain regulatory status to do companion diagnostic partnerships and bigger, Phase III clinical studies. 

"That's no different than Guardant360 or FoundationOne CDx being FDA-approved," he said, referring to competing liquid biopsy tests on the market sold by Guardant Health and Foundation Medicine, respectively. "We're not planning on doing a kitted strategy to bring Signatera around the world at this time, although it's something we’re open to in the future." 

Natera Senior VP and General Manager for Oncology Solomon Moshkevich noted that "the current Signatera product is nearing a pretty good level of maturity … and we are ready to lock that down and take that through the FDA as a single-site [premarket approval] or 510(k) if the FDA sees it that way." Natera will continue to innovate the laboratory-developed version of the assay "and stay on the cutting edge there as well," he added. 

Chapman further noted during his presentation that Natera saw increased momentum in oncology testing with more than 190,000 tests run in 2022, or an increase of 150 percent year over year. 

In the fourth quarter of 2022, more than 25 percent of all oncologists in the US used Signatera, he said, with more than 90 percent of National Comprehensive Cancer Network academic centers and 87 percent of National Cancer Institute academic centers ordering the test. Natera also saw record numbers of both new and recurring patients tested with Signatera, he added. 

The rise in oncology tests was part of an overall 30 percent increase in the number of assays run by Natera last year, over 2 million tests in total. "We've seen excellent growth in test volume," Chapman said, with record volumes in each of the firm's business units. 

For women's health testing, results of Natera's SMART (SNP-based Microdeletion and Aneuploidy Registry) trial, published a year ago in the American Journal of Obstetrics and Gynecology, are helping 22q11.2 deletion screening gain traction with clinical guideline setters, he noted. 

In addition, last month the American College of Medical Genetics and Genomics conditionally recommended that noninvasive prenatal screening for 22q11.2 deletions be offered to all patients. Natera is also awaiting action from the American College of Obstetricians and Gynecologists. 

"A lot of the ACMG guideline members in women's health are also ACOG members," he said. "If you go back and look at the fundamentals … [it checks] all the boxes. The reason we did the [SMART] study eight years ago is, we know it takes this type of study to move the needle," Chapman said. 

Chapman suggested that Natera would continue to provide "limited investment" of around $5 million per year on early cancer detection. "When we get the results of our early cancer case-control study, I think at that point, we'll have a better feeling of whether we should be pushing forward in a more significant way or not," he said. "We want to do that in a way that if we fund additional investments, it will be obvious to everyone that was the right decision." 

Chapman said a couple of months ago that Natera remains on track to deliver initial case control performance data for Signatera in colorectal cancer in 2023, with final feedback from the FDA by the end of this year. 

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