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Natera to Focus on Pharma Partnerships for ctDNA Assay Until Securing Reimbursement

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SAN FRANCISCO (GenomeWeb) – Natera said that while it is on track to launch a CLIA-validated version of its bespoke circulating tumor DNA assay, Signatera, in the second quarter of this year, it plans to continue to focus on forging deals with pharmaceutical companies, rather than on selling it for clinical testing, until it has secured coverage decisions from third-party payors.  

During a conference call on Tuesday to discuss its fourth quarter and full year 2018 performance, Natera CEO Steve Chapman also reiterated the firm's previously stated goals of getting to cash flow break even within its reproductive health business and commercializing and securing a coverage determination for its donor-derived cell-free DNA kidney transplant rejection test.

Chapman said that the company had already completed the CLIA validation for its transplant test, including publishing both analytical and clinical validation of the assay, and had submitted its dossier for Medicare reimbursement by the end of 2018. This year, he said the company plans to launch a registry study and also anticipates securing a final local coverage determination and establishing pricing and coding for the test.

In oncology, Chapman said that 2019 "can be an inflection year for Signatera," noting that the firm had signed contracts with pharmaceutical companies worth $9.1 million at the end of 2018 and expected pharmaceutical contracts to reach $40 million to $50 million by the end of 2019. 

Chapman said Natera would continue that strategy of focusing on pharma deals throughout the year, even after launching the clinical version of the assay, which it plans to do in the second quarter. While there is demand from patients and physicians who want to use Signatera to test for disease recurrence, and Natera will sell the test for those purposes, "our commercial investment will remain largely focused on pharmaceutical deals until we secure reimbursement with Medicare and commercial payors," Chapman said.

Natera plans to initially launch Signatera for minimal residual disease testing and monitoring of disease recurrence, rather than tumor profiling. The assay relies on first profiling the tumor genome via a tissue biopsy and then designing a targeted assay to monitor specific mutations via cfDNA.

The company has estimated that the market opportunity for MRD testing and monitoring is more than $12 billion. "Natera is poised to take a significant share of this market given our unique personalized approach," Chapman said.

As such, the company also plans to expand its oncology sales team to 10 people from just a few, who would continue to focus on selling to pharma companies, Mike Brophy, Natera's chief financial officer, said during the call, reiterating Chapman's comments that the firm would be "conservative" about offering the test in a clinical setting until reimbursement was more clear. In addition, Brophy noted that the company plans to launch clinical trials in some select indications "where we feel the health economics and unmet need are compelling" during 2019.

Solomon Moshkevich, general manager of Natera's oncology and transplant businesses, said that the clinical trials would also help make the case for reimbursement and that the company was working with Medicare to "set up a road map" for reimbursement.

Thus far, Natera has tested approximately 3,000 plasma samples from 700 patients across 18 different cancer types and has found that the assay can detect cancer variants down to an allele frequency below 0.1 percent. Being able to detect a variant at that low of an allele frequency will "make a clinical difference," Moshkevich said, since treatment is more effective in patients with a lower disease burden.

Chapman added that the company plans to present additional data from its pharma collaborations at the American Society of Clinical Oncology meeting this year and expects that the results from some of those collaborations would be published in peer-reviewed journals this year.

Earlier this week, Natera and BGI Genomics struck a $50 million partnership to commercialize Signatera in China on BGI's sequencing instruments.

Chapman said that the deal would also give Natera an advantage with pharma companies running trials in China, since Chinese patient blood samples cannot be sent out of the country. He added that BGI could potentially launch Signatera in China as early as 2020, noting that it would not need to be approved by China's National Health Products Association, since a number of Chinese hospitals are exempt from that provision.

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