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Natera to Seek FDA Clearance of Oncology Assay as NIPT Business Continues to Grow


SAN FRANCISCO (GenomeWeb) – Natera said it is on track for an end of the year or early 2019 launch of a clinical version of its circulating tumor DNA assay Signatera and that it planned to eventually submit it to both the US Food and Drug Administration and the Centers for Medicare and Medicaid Services.

During a conference call this week discussing the firm's first quarter 2018 performance, Natera CEO Matt Rabinowitz further elaborated on the company's commercialization strategy for Signatera and discussed progress the company has made with obtaining reimbursement for its reproductive health-focused assays.

The firm focused on penetrating the average-risk pregnancy market with its Panorama noninvasive prenatal test, unlike certain of its competitors, which pursued the high-risk pregnancy market first since testing was more likely to be reimbursed.

Now, approximately 60 percent of Natera's NIPTs are for average-risk pregnancies, while 40 percent are for high-risk pregnancies, Rabinowitz said. In addition, the firm estimated that it had captured around one-third of the overall NIPT market, but that in the average-risk market it had 55 percent or more.

Rabinowitz said that while reimbursement for average-risk testing has been slow, there are now only a few major national payors holding out on adopting coverage policies and "pressure is continually mounting." He added that it is "a given" that these payors will eventually cover testing, but that it was hard to predict the timing of coverage. "Every month or so we see additional payors cover low risk and it is a steady ongoing process," he said.


Natera launched a research-use-only version of its ctDNA assay Signatera last year, and Rabinowitz said that the firm is on track to launch the clinical version at the end of this year or early next year.

The firm is taking a slightly different approach with its Signatera assay than other companies have taken with ctDNA assays. Rather than positioning Signatera as a tumor-profiling liquid biopsy that determines the genomic alterations present in a tumor without needing a tumor biopsy, Natera is developing Signatera as a monitoring assay.

The firm sequences the patient's tumor genome from a standard tumor biopsy, and based on the results develops a bespoke assay targeting around 16 clonal mutations. It can then track the presence of the tumor as well as whether it is growing or shrinking by looking for and quantifying the tumor mutations in a patient's blood.

On the call, Rabinowitz highlighted recent data that the firm presented at the American Association for Cancer Research meeting demonstrating that the assay could predict relapse on average 4 months earlier than standard imaging tests for lung and bladder cancer patients and an average of more than 7 months earlier for colon cancer patients.

He said that the firm also has ongoing studies in breast cancer and would share data from those studies in the next several months.

Rabinowitz said that the firm plans to leverage its existing phlebotomist infrastructure that it has in place for its NIPT business when it launches the clinical version of Signatera. It will also take a similar commercialization strategy that it took with Panorama. It will pursue reimbursement for Signatera, including by submitting the assay through the Parallel Review Program for approval by the FDA and coverage determination by CMS, similar to the strategy Foundation Medicine took for its NGS-based genomic profiling test FoundationOne CDx. Rabinowitz did not provide a timeline for the submission.

Although the goal is to secure reimbursement for the test, Rabinowitz said that even if insurance does not cover the test, it would use its existing billing infrastructure to bill patients directly. In the US there are approximately 18 million patients living with or in remission from cancer, and Rabinowitz said that for those patients, a test that could detect recurrence earlier than imaging and that doesn't come with the radiation and ongoing doctor visits of imaging tests "is a very attractive offering."

Signatera represents a "big cash pay opportunity," he added, because the assay is very low cost to run and can "go down to a roughly single-molecule level of detection."