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Natera Seeks Medicare Coverage for Oncology Test, Launches Clinical Studies for Transplant Assay

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NEW YORK – While still obtaining the vast majority of its revenues from its Panorama noninvasive prenatal screening and Horizon carrier screening tests, Natera is forging ahead with its Signatera circulating tumor DNA minimal residual disease (MRD) test and its Prospera transplant assessment assay.

During a conference call this week to discuss the firm's second quarter earnings, Natera officials provided an update on these efforts, including clinical trials, Medicare reimbursement, and commercial partnerships.

CEO Steve Chapman said that Signatera is focused on disease monitoring and MRD assessment, a $15 billion market opportunity. The test has three main indications — determining recurrence risk to support treatment decisions, detecting recurrence following therapy, and monitoring therapy effectiveness — and "we're making meaningful progress in each of these areas," he said.

The first cancer type Natera has developed Signatera for is local or regionally advanced colorectal cancer. According to Solomon Moshkevich, the firm's general manager for oncology and transplant, the CRC market opportunity is four to five times larger than the market for Natera's Prospera kidney transplant monitoring test, as there are about 100,000 annual new cases of advanced CRC in the US and about 1 million existing cases, who could all be monitored several times per year.

Moshkevich said there is unmet clinical need in two areas of advanced CRC. Up to 30 percent of patients will relapse, he said, and early relapse detection is known to improve outcomes. A combination of imaging and serum biomarker screening is currently used to monitor patients, but more than 85 percent of recurrences are caught too late for curative surgery. A study of Signatera, published this spring in JAMA Oncology, he said, showed that the test detected relapse earlier than standard assays and with fewer false-positive results.

The second potential use of Signatera is for deciding about adjuvant chemotherapy after surgery to eradicate micro-metastatic disease. "Using Signatera to stratify patients can lead to more patients getting treatment who need it and a significant reduction in unnecessary treatment," he said.

Moshkevich said that based on the colorectal cancer data from the JAMA Oncology study and results in other cancer types, Natera recently submitted a formal coverage dossier to Palmetto and expects to obtain a draft local coverage decision either late this year or early next year. "This plan is similar to the one that we followed in our kidney transplant effort and we're working with the same team at MolDx for this submission," he said.

While waiting for the draft LCD, the company has "a small focused effort underway" to drive the clinical adoption of Signatera for colorectal cancer, he added, which will be expanded once the company has the LCD in hand.

"Once the CRC indication is secured, we look forward to rolling out and pursuing reimbursement for a significant number of additional indications, both directly and, in some cases, through collaborations with pharma," Moshkevich said.

One other potential use of Signatera is to evaluate a patient's response to immunotherapy, which he said Natera demonstrated in a study presented at the American Society of Clinical Oncology annual meeting this year.

Specifically, the study, performed in collaboration with researchers in Toronto, looked at metastatic cancer patients with different tumor types who were treated with pembrolizumab (Merck's Keytruda) and showed that Signatera could differentiate between actual disease progression and pseudo-progression, he said. It also detected progression earlier than imaging. "This has significant implications for pharmaceutical companies who are looking to use Signatera as a surrogate endpoint in clinical trials to get a faster readout on treatment efficacy," he said.

In addition, the study "showed significant potential for Signatera in the clinical metastatic setting for earlier identification of patients who were not responding to treatment and who may proceed to alternative treatment options sooner, as well as identification of complete responders who may safely de-escalate therapy or take a drug holiday while under continued surveillance," he said. Chapman said Natera has already seen interest in Signatera for therapy effectiveness monitoring from pharma companies.

Overall, Natera is on track to secure contracts with pharmaceutical companies worth a total of $40 million to $50 million this year for Signatera. "Our goal was to generate revenue growth in the oncology business through successful commercialization of Signatera," Chapman said. "We're pleased with our trajectory in pharma and now we're very excited about the clinical opportunity in colorectal cancer as likely the first among many future indications."

Natera also continues to work with BGI on the commercialization of Signatera in China, a partnership announced in March, and recognized $5 million in revenue from BGI in Q2 for milestones and development work. Moshkevich said this revenue is part of the $28 million in upfront payments that Natera has received from BGI as part of the deal, adding that the firm expects to receive about $30 million from BGI in total this year.

Chapman said he anticipates Natera to sign several additional multi-year development and commercialization partnerships for its tests, adding to the existing deal with BGI and the 10-year partnership with Qiagen, announced last year, to develop cell-free DNA assays for Qiagen's GeneReader, including the Panorama NIPT.

Specifically, he said Natera plans to announce another "major partnership" in the second half of the year.

Regarding the collaboration with Qiagen, "there is a lot of very positive development work that has been done and the teams are working very nicely together," he said, but he declined to provide a timeline for a product launch. "It's really up to Qiagen, and we'll look for them to really take the lead on announcing that," he said.

For its transplant assessment test, Prospera, Natera recently launched the ProActive trial, which Chapman said is the largest prospective registry trial for kidney transplant monitoring. The goal of the study, which is led by Jonathan Bromberg at the University of Maryland School of Medicine and will start enrolling patients later this year, is to recruit more than 3,000 patients at a number of leading transplant centers and to follow them for three to five years post transplant.

A second prospective multi-center trial, involving approximately 15 sites, will study Prospera along with a microarray-based assay to assess kidney transplant rejection. The array assay, called Molecular Microscope Diagnostic System (MMDx), measures gene expression in biopsy tissue. The study, led by Philip Halloran from the Alberta Transplant Applied Genomics Centre at the University of Alberta in Canada, aims to enroll at least 300 patients with biopsy-matched blood samples and will "provide further evidence of our assay performance, including new subgroups, and … will generate key insights into the benefits of monitoring patients with a full suite of molecular testing," Chapman said.

Thermo Fisher Scientific's One Lambda, which is a US distributor of the Prospera test, holds an exclusive license for the commercialization of the MMDx assay, he added.

Natera has also been making headway in securing reimbursement for Prospera. In March, it received a draft LCD from Palmetto, followed by several other draft LCDs, including from Natera's local Medicare contractor Noridian in May. "We are closing in on our final LCD and release of final pricing, which we still anticipate happening in 2019," Chapman said, which will allow the company to commercialize the test.

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