NEW YORK – Buoyed by a 26 percent year-over-year increase in third quarter revenues from growing testing volumes, Natera officials this week outlined how they plan to grow sales further, including in the company's core reproductive health and its nascent oncology and organ transplant testing businesses.
Following new practice guidelines from the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine this summer that recommended noninvasive prenatal testing for all pregnancies regardless of risk, Natera has seen a steady increase in its NIPT business, with more orders coming in for tests in average-risk pregnancies.
In a conference call to discuss the firm's financial results this week, CEO Steve Chapman pointed out that the guidelines highlighted the unique capabilities of SNP-based NIPTs for detecting triploidy and zygosity in twin pregnancies, noting that Natera's Panoroma test is the only assay to date that uses a SNP-based method. "These advantages are unique to Natera and help us differentiate in the market," he said.
More payors have started to cover NIPT this year, he said, in particular following the ACOG/SMFM practice bulletin. Some of these payors not only include all-risk pregnancies but also twin pregnancies in their coverage, "which provides additional upside to Natera," Chapman said. "Notably, we were very pleased to recently see payors like Humana and Centene join the majority of payors covering NIPT for all women," he said, adding that coverage policies now add up to more than 200 million covered lives. One notable payor that is still resisting is UnitedHealthcare, he said, "but it's been important to see a wave of very large and prominent payors quickly changing their coverage policies post ACOG."
In addition, Natera expects a boost to its reproductive health business from the results of the SMART (SNP-based Microdeletion and Aneuploidy Registry) trial, a five-year, prospective, 20,000-patient, multisite clinical trial with outcome data from births that has just wrapped up. The results will be first presented at the SMFM annual conference at the end of January, Chapman said, and "have the potential to further drive market share in NIPT, and may unlock guidelines and reimbursement for microdeletion" testing. He added that Natera already runs 100,000 microdeletion tests per quarter.
Overall, he said, the US market for NIPT consists of 4 million to 5 million pregnancies per year. Of those, 80 percent are low-risk pregnancies, but only 25 of these receive noninvasive prenatal testing at the moment, "so we still have significant room to run in the NIPT space." Natera currently holds slightly above 50 percent market share for NIPT, he said.
Natera's oncology business is also on track to expand further. Chapman reiterated that the company received a final coverage decision for its Signatera test in stage 2 and 3 colorectal cancer, and a draft local coverage decision for its use in immunotherapy monitoring. These two indications alone, he said, could translate into almost 2 million Signatera tests per year.
Solomon Moshkevich, general manager for Natera's oncology business, explained that about 145,000 patients in the US are diagnosed with colorectal cancer each year, about two-thirds of them with stage 2 or 3 cancer. "With the repeat testing described in the Medicare coverage policy, this would imply roughly 1 million tests per year as a total addressable market," he said.
The final coverage decision for this indication went into effect Oct. 18, he said, but Natera is still working on pricing with the US Centers for Medicare and Medicaid Services, which it expects to finalize over the next two weeks. "For competitive reasons, we do not plan to disclose final pricing when it is completed," Moshkevich said, but the company believes pricing will be consistent with what other firms are receiving for cancer minimum residual disease testing. "As a result, we're now moving into the formal commercial launch phase for Signatera in the clinical setting for colorectal cancer, and we plan to build on the momentum we've seen in the prelaunch phase," he said.
Signatera also received a positive draft local coverage decision for immunotherapy monitoring in September and could be used in the 200,000 patients that currently receive immunotherapy for diverse cancer types every year. Assuming each patient receives four Signatera tests per year, the addressable annual market could exceed 800,000 tests, Moshkevich said, adding that Natera expects to receive a final coverage decision and pricing for this indication in 2021.
Natera has also been growing its pharmaceutical business, running its Signatera tests as part of several clinical trials, including with Pfizer and Novartis on monitoring therapy response in early-stage breast cancer. "If successful, we expect that positive data from these and other trials would continue to expand the addressable market for Signatera" into early-stage breast cancer recurrence monitoring, Chapman said.
Data on studies that will presented at three upcoming conferences this year will further make the case for the use of Signatera, he added. These include an oral presentation on bladder cancer at the ESMO Immuno-Oncology Congress in December and several poster presentations on breast cancer at the San Antonio Breast Cancer Symposium, also in December.
Finally, Natera's organ transplant business has also been making strides. After securing a final local coverage decision for its Prospera transplant monitoring assay in May, the company launched the assay commercially in the second quarter and continues to generate data on its use, Chapman said.
For example, it recently published new data showing that nephrologists who used the Prospera test detected more cases of rejection and made better clinical decisions than those who did not, he said. In addition, Natera presented a study last month on the performance of its test in patients with a second kidney transplant and in those with COVID-19 or other viral infections. The company also recently launched a program to improve care for organ transplant patients with a history of cancer. "The goal is to understand how Signatera and Prospera could be used together to improve clinical decision-making and respond to the unmet medical needs in these communities," Chapman said.