NEW YORK (GenomeWeb) – Natera officials said this week that the firm's focus on the average-risk pregnancy market for its noninvasive prenatal test has given it a competitive advantage both for its Panorama NIPT as well as its Horizon carrier screening test.
In addition, the firm said this week that 17 health insurance plans representing 55 million covered lives have begun reimbursing for NIPT for average-risk pregnancies.
Natera is also quickly moving into the oncology space and recently published its first proof-of-concept study in breast cancer samples, demonstrating its liquid biopsy assay could detect subclonal mutations present at less than 1 percent frequency, company officials said during a conference call discussing its third quarter 2015 results.
Within the reproductive health market, Natera identified a number of factors that differentiate it from competitors. First, Natera decided from the beginning to invest heavily in the average-risk pregnancy market, Natera CEO Matthew Rabinowitz said during the call. It has a dedicated sales team for Ob-Gyns, which has helped volumes of all three of its three reproductive health tests: Panorama NIPT, the microdeletion panel, and the Horizon carrier screening test.
The Horizon carrier screening has done especially well since the firm launched an expanded version of the test in July. The firm sold 13,000 carrier screening tests in the quarter. By contrast, Sequenom has seen low uptake of its universal carrier screening test — in part because the firm has not focused on selling into the obstetric market.
Natera also said that its focus on the Ob-Gyn market will help it tap into the average-risk pregnancy market and is enabling it to cross-sell its Panorama and Horizon tests, Rabinowitz said.
The firm is also taking a very different strategy in the average-risk market than Sequenom, which developed a separate test for average-risk pregnancies that only screens for trisomies 21, 18, and 13. Natera, by contrast, thinks that including microdeletions for average-risk pregnancies will be as important. Recently, the firm published a study in the Obstetrics and Gynecology Journal that found the microdeletion known as 22q11.2, had a prevalence of about 1 in 1,200, or similar to that of cystic fibrosis in males.
"Our perspective is that in the low-risk market, a broader panel that includes 22q11.2, which is more common than Down syndrome in women under 28, is going to be necessary" and "what doctors and patients want," Steve Chapman, Natera's senior vice president of commercial operations, said during the call. "The bifurcated strategy where there's two completely different tests — one limited, one more broad — with two different pricing schemes, is not something that we're observing at this time," he added.
Aside from its test offerings, Rabinowitz said that Natera's focus on its "digital offerings" has helped differentiate it from the competition. For more than 60 percent of Natera's customers, the firm's testing results are either "integrated into [health providers'] electronic medical record platforms," or providers have signed up for the firm's physician web portal, Natera Connect. "This allows us to seamlessly integrate with a physician's patient management software to receive orders and send back test results," Rabinowitz said. In addition, it helps reduce paperwork and the numbers of missing or inaccurate insurance information.
Natera is also focused on developing an oncology assay that will use the same technology in its Panorama NIPT to evaluate circulating tumor DNA. Recently, the firm described the technology — massively multiplexed PCR plus NGS—at the American Society of Human Genetics meeting.
During this week's call, Rabinowitz said that the firm is collaborating with a number of academic cancer centers including those affiliated with Columbia University, Cancer Research UK, Stanford, Vanderbilt, and the University of Pittsburgh Medical Center.
Already, it has published a proof-of-concept study in Translational Oncology, showing that its liquid biopsy technology can detect copy number variants in breast cancer at average allelic imbalances as low as .5 percent.
Rabinowitz said CNV detection will be a "key capability" of a liquid biopsy assay for therapy selection since "many targeted therapies depend on CNV status for selection."
He added that Natera will initially develop tests that focus on breast, ovarian, and lung cancer for "therapy selection and recurrence monitoring in patients where cancer has already been diagnosed, or for screening high-risk populations where either a genetic predisposition exists or a nodule has been detected." The ultimate goal, however, is to have a test for early detection of cancer.
Rabinowitz noted that the company expects to publish data from three types of studies in 2016. First, he said, it will have results from studies that evaluate the ctDNA assay in lung cancer patients, demonstrating concordance between the ctDNA assay and sequencing of a tumor biopsy. That data will "provide the groundwork for commercialization" of a ctDNA panel for guiding therapy selection, initially for lung cancer, but eventually for other cancer types.
The firm also expects data to be available in 2016 from its 840-patient Tracking Cancer Evolution through Therapy (TRACERx) study, to demonstrate the ctDNA assay's ability to track clonal and subclonal mutations over time and to "demonstrate analytical performance for disease load and recurrence monitoring," Rabinowitz said.
Lung cancer will likely be the first indication for which Natera commercializes its ctDNA assay for therapy selection. Approximately 220,000 patients are diagnosed with lung cancer annually and around 20 percent of them are not amenable to having an invasive biopsy, Rabinowitz said. If Natera's studies can demonstrate that a blood-based assay can identify the same mutations as a tumor biopsy, "our blood test would represent an attractive alternative," he said.
He also noted that the firm plans to have initial results from ovarian cancer studies, evaluating sensitivity and specificity of the ctDNA assay to screen for cancer in high-risk patients.