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Ariosa Licenses NIPT Technology to German Startup, Others Following CE Marking of Test Algorithm


This article has been updated to correct pricing information for one of Cenata's tests.

NEW YORK (GenomeWeb) – Roche's Ariosa Diagnostics has licensed its Harmony noninvasive prenatal test to several laboratories outside the US, starting with Cenata in Germany, after obtaining the CE mark for its proprietary analysis software.

Cenata, a startup based in Tübingen, established the test technology in its laboratory in April and has run more than 1,000 samples since offering Harmony in early May. It is the first external laboratory running the test, which was previously performed exclusively by Ariosa's CLIA-certified laboratory in San Jose, California.

Roche acquired Ariosa late last year for $400 million in cash and up to $225 million in contingent payments. Ariosa has been offering the Harmony Prenatal Test, which examines the risk of trisomies 21, 18, and 13 as well as sex chromosome abnormalities from circulating cell-free DNA in the mother's blood, since 2012. Harmony is available in more than 90 countries, and the company has run more than 500,000 tests.

Cenata has the right to offer the Harmony test globally except in the US, and with certain limitations in Spain and Portugal. It currently focuses on the German market but has plans to offer the test elsewhere in Europe, such as Spain, Austria, Switzerland, and Eastern European countries, as well as in Saudi Arabia, according to Dirk Biskup, one of Cenata's managing directors.

Dave Mullarkey, chief operating officer of Ariosa, told GenomeWeb that his company has seen an interest from labs around the world to perform the Harmony test locally rather than having to ship samples to the US. Besides Cenata, Ariosa has signed licensing agreements with at least one other laboratory in Europe and is in discussions with several labs around the world.

Ariosa is still pursuing CE-IVD certification for the test, he said, which it hopes to apply for later this year.  

Cenata was founded by Labor Enders, a medical diagnostic lab in Stuttgart; the Center for Genomics and Transcriptomics (CeGaT), a molecular diagnostics firm in Tübingen; and Miguel Hinrichsen, a gynecologist based in Hamburg, who all provide funding to the firm. It is housed on CeGaT's premises but operates independently from its parent and currently has fewer than 10 employees.

Kai Lüthgens, Cenata's other managing director, told GenomeWeb that Labor Enders had been distributing Ariosa's Harmony test in Germany since September of 2013. But the lab ran into liability issues and political challenges, mainly associated with the fact that the patient samples were sent to the US for analysis, and asked Ariosa whether it could transfer the technology.

Other NIPT developers have pursued similar strategies — Illumina, for example, transferred its Verinata test technology to several European laboratories last year, and Premaitha Health, which obtained CE-IVD certification for its Iona test earlier this year, has made it available through labs in Poland, Switzerland, and the UK.

Biskup said that Cenata did market research on several available NIPT and concluded that the Harmony test, which Ariosa recently switched from a next-gen sequencing to a microarray platform, was the best in terms of quality, price, and turnaround time, and had large clinical validation studies associated with it.

Transferring the technology to Cenata was a smooth process, he said, involving a team of eight Ariosa employees who came over to Germany in April. Cenata set up the test after Ariosa obtained CE marking for its proprietary FORTE software that analyzes data from cell-free DNA for the Harmony test. The software is installed locally on a server of the testing lab, so no patient data leaves the laboratory.

Cenata offers three versions of the test — for trisomies 21, 18, and 13, with optional sex determination and optional sex chromosomal analysis — at a price of €399, €429, and €449, respectively. The test has a turnaround time of four to six business days and is available to women with high-risk as well as average-risk pregnancies.

All test results are signed off by a clinician, which Biskup said distinguishes Cenata from some other NIPT providers who do not have physicians on staff.

At the moment, the test is covered by certain private health insurance companies in Germany. The country's statutory health insurance system covers the test on a case-by-case basis only, and a decision on general coverage of NIPT is expected later this year.

Going forward, Cenata plans to conduct a clinical study to validate the test in a German population.