NEW YORK (GenomeWeb) – Natera said this week that reimbursement is continuing to pick up for its noninvasive prenatal tests, even for women with average risk pregnancies, and that it expects to secure a CPT code for testing for the 22q microdeletion in January.
During a conference call discussing its third quarter 2016 earnings, CEO Matt Rabinowitz said that Natera is also developing new products in the reproductive health space as well as continuing its push into oncology. He said that the company plans to expand on an existing collaboration with Cancer Research UK, analyzing cell-free DNA from non-small cell lung cancer patients, and will also move into other indications and announce new collaborations.
Reimbursement for noninvasive prenatal screening tests has increased steadily, if somewhat slowly, for all firms offering tests but has been primarily limited to high-risk pregnancies. Natera, however, made a push to capture market share in the average-risk pregnancy market, which constitutes around 3.3 million births in the US per year versus 800,000 births in the high-risk setting. Rabinowitz said this week that the firm is now starting to see broader reimbursement for average risk pregnancies and is the market leader in the field.
Of the 200 million to 220 million total covered lives in the US, around 90 million lives are covered under plans that include NIPT for average risk pregnancies. "There's been continuous momentum since July 2015 when very few plans covered NIPT for average risk pregnancies," Steve Chapman, Natera's chief operating officer, said during the call. Since the fourth quarter of 2015, he said there has been around 60 percent growth in the number of covered lives that include NIPT for average risk.
One key to continuing to be reimbursed for average risk pregnancy testing is an upcoming publication of a trial assessing Natera's Panorama in 3,000 women with average risk pregnancies. "The data will help answer many remaining questions regarding patient education and counseling of NIPT in the general population," Rabinowitz said, as well as "the clinical utility of NIPT in all risk categories."
Aside from selling to the general obstetrics market, Natera is looking to service entire hospital systems, Chapman said. Hospital systems are beginning to update their policies to recommend that physicians offer NIPT to all pregnant patients, regardless of their risk. He said that Natera had recently entered into an arrangement with an unnamed large hospital system representing thousands of births per year. "That represents the next stage of penetration," he said.
Rabinowitz noted that the company also expects improved reimbursement for microdeletion testing. The company met with the Centers for Medicaid and Medicare Services this summer to discuss pricing for a new CPT code for microdeletions. Four members of that panel recommended a price of $797 while eight members recommended using a gap fill process. Rabinowitz said he expected a final decision soon, but regardless, the $797 price "helps us set a benchmark for negotiations with private payors as they set their rate plans for 2017."
In August, Natera implemented the first phase of improving on the cost of goods sold as well as the performance of its technology. Rabinowitz said that based on data from its clinical experience of micordeletion testing, the company realized it could improve performance of testing for 22q microdeletion syndrome by resequencing those patients whose test indicated a high risk. That will reduce the false positive rate by a "factor of three" to .12 percent, and increase the positive predictive value to 40 percent from 18 percent.
Rabinowitz said Natera is now "entering the final validation stages" of its V3 technology.
In its oncology business, Rabinowitz noted that the firm would expand on its collaboration with CRUK to include both additional work in lung cancer as well as additional indications.
In April, Natera presented data from its TRACERx (Tracking Cancer Evolution through Therapy) lung cancer study representing a subset of 50 treatment-naïve patients. Rabinowitz said that Natera has since received preliminary results from the next 50 patients, including longitudinal blood samples from patients who relapsed. "We believe we can detect recurrence four to six months earlier than standard markers or imaging tools," he said. Over the next few months, Rabinowitz said the company plans to report test performance details and initial clinical validity of its massively multiplexed PCR (mmPCR) platform, which it described initially at a conference last year.
As previously reported, Natera is also building up a biobank of ovarian and breast cancer samples. For ovarian cancer, Natera is focused on women who present with indeterminate pelvic masses. Doctors currently "have no good tools" to determine whether those masses are cancerous or not. Needle biopsies are not recommended due to the potential of spreading a malignancy. So, Natera is focused on developing a noninvasive test to "detect cancer earlier, avoid unnecessary surgeries, and bring reassurance to the woman without a malignancy," Rabinowitz said.
With regards to breast cancer, Rabinowitz said the company is focused on designing a test that could be used when an imaging test is ambiguous, for disease recurrence monitoring, disease load monitoring, and eventually early detection.