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Natera's testing volumes increased but revenues declined due to achieving in-network status with payors and being reimbursed at a lower rate.
Since April 1, noninvasive prenatal testing, provided by three university genetic centers, is available to all pregnant women in the Netherlands for €175 as part of the TRIDENT-2 study.
The firm can now sell VeriSeq NIPT as a CE-IVD in Europe for trisomies 21, 18, and 13, as well as some sex chromosomal aneuploidies.
At the German Society of Human Genetics annual meeting in Bochum, Berlin's Atlas Biolabs talked about its first experience with the Clarigo test.
Natera saw total Q4 2016 revenues decline to $49.3 million, despite an increase in testing volumes.
The firm reported $3.5 million in revenue for the three months ended Dec. 31, 2016, and $12.9 million for the full year.
The firm has seen a small handful of false positives for the test in thousands of samples run since the study, but attributed them to biological features.
The G-BA commissioned a contractor to prepare an evidence report by early 2018 and to gather information for patients by early 2019.
The firm plans to include seven subchromosomal alterations to its NIPT by the end of March and wants to expand into the liquid biopsy market.
Starting Feb. 15, Aetna members will be able to access NxGen MDx's genetic screening and noninvasive prenatal testing as an in-network benefit.