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Natera Plans New Reproductive Health Tests; Reports Progress in Oncology


SAN FRANCISCO (GenomeWeb) – Natera plans to make use of its ability to analyze fetal fraction when running its noninvasive prenatal test to add extra value to its current test and to develop new reproductive health products, the company said this week.

During a conference call discussing the firm's second quarter results this week, Natera CEO Matt Rabinowitz discussed the firm's plans to commercialize fetal fraction analysis, and provided an update on its pharmaceutical collaborations on its circulating tumor DNA assay Signatera and its recent decision to enter the transplantation business.

In addition, the company noted that it is anticipating more reimbursement for NIPT in the average risk market, which makes up about 60 percent of Natera's Panorama test sales. The American College of Obstetrics and Gynecology recently withdrew a bulletin where it did not recommend NIPT as a first-line screen for average risk pregnancies and Natera said it was possible that ACOG would issue a new, more favorable, opinion. Payors often base reimbursement decisions on guidelines from professional organizations, so if a new guideline were to be implemented, payors could change their policies.

"All indications are positive, but we have to be cautious," Rabinowitz said.

Earlier this month, Natera published a study in Ultrasound in Obstetrics and Gynecology showing that fetal fraction could be used to predict risk of fetal chromosomal abnormalities. Natera currently analyzes fetal fraction when it runs its noninvasive prenatal test Panorama, but fetal fraction is primarily used to judge whether or not there is enough fetal DNA to accurately detect aneuploidies. However, in the new study, the researchers showed that it could be used to predict risk.

In the study, researchers used data from more than 165,000 pregnancies that had been tested via Panorama to develop a fetal fraction risk prediction algorithm. The researchers took into consideration maternal weight and gestational age to predict fetal fraction distributions for normal, trisomy 13, trisomy 18, and triploid pregnancies. They then ran it on 1,148 samples for which Panorama did not return a result but for which retrospective outcomes data was available.

The researchers found that the algorithm called about half of the cases as high risk and that those cases were more likely to have had trisomy 13, trisomy 18, or triploidy than the cases that were not high risk. Of those, around 22 percent had trisomy 13, trisomy 18, or triploidy. Overall, the algorithm had a sensitivity of 91.4 percent and a positive predictive value of 5.7 percent.

Steve Chapman, Natera's chief operating officer, said that the company plans to include that algorithm in its Panorama test beginning in the third quarter this year. Such analysis "could help extend our leadership position in NIPT," he said. In the study, the researchers noted that the algorithm could be useful, particularly for cases in which the standard Panorama test is not able to return a result due to low fetal fraction.

In addition, Chapman said that within an ongoing prospective 20,000-patient clinical trial the firm has been conducting, known as the SMART trial, the company planned to study whether the biomarker could be used to help predict risk of preterm birth and preeclampsia.

Rabinowitz noted the firm plans to leverage its database of over 1 million commercial samples and the "extensive clinical data we're collecting as part of the SMART trial" to improve its current products and develop new ones.

On the oncology front, Rabinowitz said that the firm has struck around 20 agreements with pharmaceutical companies to use its Signatera assay in studies. Importantly, he noted, one prospective study will use Signatera to monitor therapy response and will include measuring clinical outcomes. Another potential study that is about to be signed will include using Signatera to determine which patients would benefit from adjuvant treatment.

Chapman added that the firm is on track to launch the CLIA-certified version of Signatera in early 2019.

As announced in June, Natera plans to enter the transplantation business with a test that will identify acute rejection in kidney transplant recipients, following the results of a study it collaborated on with researchers from the University of California, San Francisco.

Chapman elaborated further on the firm's plans to enter the market and secure reimbursement for its test. In the near term, he said, Natera will publish the results of its analytical validation study and complete its clinical validation study. In addition, he identified two pathways for securing reimbursement. The first step would involve submitting an application for a Z code along with a local coverage determination to achieve coverage by December 2019 with pricing set by MolDx. Given that a similar test commercialized by CareDx is priced at $2,800, Chapman said he anticipated a comparable price for Natera's test. This option is the more straightforward of the two, he said.

Alternatively, the company could submit an application for a proprietary laboratory analyses and either go through a crosswalking process or negotiate with MolDx to determine pricing.

Rabinowitz also noted that the firm planned to participate in a registry study to help establish itself and gain buy-in from customers, similar to what CareDx has done. The company was also confident that its study with UCSF, despite being only a single-center study unlike CareDx's multi-center study, would be sufficient to secure reimbursement.