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As Reproductive Health Business Grows, Natera Eyes Oncology, Consumer Markets

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SAN FRANCISCO (GenomeWeb) – Natera said this week that sales of its noninvasive prenatal and carrier screening tests continue to grow, and although reimbursement progress for average-risk NIPT has been slow, it is ultimately inevitable in the US.

Natera CEO Matt Rabinowitz said during a conference call to discuss the firm's third quarter earnings that while the company will continue to focus on improving its tests to gain market share, such as its recent expansion into assessing twin pregnancies, it is also looking toward new markets like oncology and eventually consumer genomics.

Natera launched its research-use-only circulating tumor DNA assay, Signatera, earlier this year and Rabinowitz said that the launch has gone better than expected. The company has signed deals with pharmaceutical companies to use the assay in eight pilot studies. It is also working on doing its own validation studies that will support the launch of a clinical version of the test next year and has entered into academic partnerships in Denmark and the UK.

Rabinowitz said that the assay appears to be "well-suited to the nascent and rapidly growing field of immuno-oncology."

Solomon Moshkevich, Natera's senior vice president of product and strategy, said during the call that the firm expects to sign additional deals with pharmaceutical companies before the end of the year.

Moshkevich said that Natera is targeting four indications: therapy response monitoring, recurrence monitoring, the adjuvant setting, and the neoadjuvant setting. He said that the firm hopes to set itself apart from the growing array of other companies developing liquid biopsy assays with its personalized approach. Each Signatera assay is designed to target specific mutations found in a patient's tumor, which the firm first sequences.

For recurrence monitoring, Natera has already published one study demonstrating Signatera's potential in lung cancer, and it is collaborating with academic labs in Denmark and the UK to study the assay's ability to make "prognostic claims for recurrence monitoring" in colorectal, bladder, and breast cancers.

In the adjuvant setting, Moshkevich said the goal is to use Signatera to better predict which patients who have had their tumors surgically removed will also need to be treated with chemotherapy. For instance, he said, for colorectal cancer patients, he said that although about 20 percent receive chemotherapy after surgery, only about 2 percent to 4 percent actually benefit from it. "Determining who should get adjuvant treatment is a real diagnostic dilemma for physicians," he said.

One area in particular that pharma has been interested in is using Signatera to evaluate patients' response to immunotherapy, he said.

In particular, Moshkevich said, Signatera is well-suited for pharma companies that are developing tumor-specific neoantigen therapies. Those drugs essentially "train the immune system to attack neoantigens found uniquely in that person's tumor cells," but not normal cells, he said. Such personalized vaccines are a good fit with Signatera, he said, since each Signatera assay is also unique to the patient and can be designed to "match the mutations associated with each patient's vaccine."

Moshkevich noted that oncology testing represents a $14 billion annual market in the US, assuming a $500 price point per test.

Natera also is interested in broadening its array of genetic tests beyond its reproductive health and oncology businesses, a move made possible by its patient portal and cord blood banking service, Evercord, which will eventually open up opportunities to do exome or whole-genome sequencing at birth.

Several hundred thousand patients per year funnel through the patient portal, Steve Chapman, Natera's chief operating officer, said on the call, and they interact with the company and develop relationships. Chapman said the company would look to use that opportunity "to sell some consumer-facing genetic tests."

"It is a frontier that we have been talking a lot about and waiting for the right time, and I think the time is approaching," Rabinowitz added.

In the meantime, however, Natera continues to work on driving its noninvasive prenatal and carrier screening tests, and while it has been successful at gaining stable reimbursement for NIPT in the high-risk setting, reimbursement for average-risk pregnancies and microdeletion testing has been slow. In the third quarter, Natera estimated it processed 28,000 average-risk NIPTs and 41,000 microdeletion tests that will not be reimbursed.

It is also continuing to expand its single-gene NIPT, Vistara, which aims to detect de novo point mutations that can lead to serious disorders. Thus far, Rabinowitz said that the test has returned 21 positive calls, and in the cases where there are follow-up diagnostic tests, results have been concordant. In the cases where patients have not had diagnostic tests, the results match either the ultrasound abnormalities or family history, he said.