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Germany Slow to Adopt NIPT as LifeCodexx Gains Trial Reimbursement, Illumina Signs Partnership

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NEW YORK (GenomeWeb) − Competition for non-invasive prenatal testing in Germany is heating up, with Illumina announcing this week that it has teamed up with a German diagnostic laboratory and other European labs to transfer Verinata's test technology to those countries, and LifeCodexx saying last week that its PrenaTest will be reimbursed by Germany's statutory health insurance on a trial basis starting next year.

The market potential for NIPT in Germany is substantial. The country had almost 675,000 live births in 2012, and an increasing number of pregnancies are considered above average risk.

Adoption of NIPT in Germany has been slow, however. LifeCodexx, a subsidiary of DNA sequencing service provider GATC Biotech, introduced its PrenaTest in the summer of 2012 and has so far performed about 5,500 tests in Germany, and an equal number in other, mostly European countries, CEO Michael Lutz told Clinical Sequencing News. The company, which has licensed intellectual property from Sequenom, performs all testing at its Constance Laboratory, using the Illumina HiSeq 2500 platform.

The company initially faced fierce criticism from various interest groups fearing the test would lead to an increase in the number of abortions. While that opposition still exists, media coverage has calmed down somewhat, Lutz said, and uptake for the test has been growing.

Ariosa Diagnostics and Natera, LifeCodexx's current competitors in Germany, apparently have done no better. Ariosa launched its Harmony test in Germany in late 2013, offering it through Sonic Healthcare Germany, a medical diagnostics company, though all testing is performed in Ariosa's US laboratory. According to a recent article published in Die Welt, a national German newspaper, which cited data from test manufacturers, 3,500 women in Germany have taken the Harmony test so far, a number Ariosa declined to confirm.

According to the same article, 2,500 Natera Panorama tests have been performed on women in Germany so far. Natera introduced its test in Germany in May of 2013, distributing it through Amedes Group, a German diagnostic service provider. The company did not confirm the number of performed tests before press time.

Up until now, none of the tests have been covered by Germany's statutory health insurance system, which covers about 90 percent of the country's population, although Lutz said that individual providers – both private and statutory – have covered the PrenaTest on a case-by-case basis. For most women, the test has been an out-of-pocket expense. Prices currently range from €595 for a version of PrenaTest that only screens for trisomy 21 and has a turnaround time of seven to eight business days to €995 for a fast option that includes trisomies 21, 18, 13, Turner, Triple X, Klinefelter, and XYY syndromes and has a turnaround time of three to four business days.

Access to the test might increase with the recent decision of the Joint Federal Committee, G-BA, which determines which medical services are reimbursable under Germany's statutory system, to cover the PrenaTest on a trial basis under a new reimbursement scheme, following LifeCodexx's application last year.

Starting in the first half of 2015, patients will be reimbursed for PrenaTest at a rate that has not been determined yet, while G-BA will sponsor a clinical validation study. According to Lutz, details of the study protocol have yet to be determined, but it will only include trisomy 21 and will likely be conducted in women with above-average risk pregnancies.

In addition, since early 2013, LifeCodexx has been conducting its own prospective post-marketing clinical follow-up study on PrenaTest, in collaboration with the University of Bonn, for which it is recruiting 2,000 patients in Germany.

So far, LifeCodexx's test is the only NIPT that has been accepted by the G-BA for trial-based reimbursement. According to the company, it was selected because of its compliance with the European In Vitro Diagnostic Directive and its use of data analysis software that has been CE marked as a medical device.

"The reimbursement is very important," Lutz said, noting that his company has been criticized for the initially high price of its test. "With the reimbursement, this test … is becoming something that's pretty much accessible to every pregnant woman," he said, initially those with high-risk pregnancies, and he expects test adoption to climb.

While LifeCodexx is also offering PrenaTest outside of Germany – according to its website, the test is available in at least some clinics in more than 30 countries, including Austria, Switzerland, Hungary, Bulgaria, Ukraine, Russia, and Turkey – competition within Germany is growing.

Earlier this week, Illumina said that is has teamed up with the Center for Human Genetics and Laboratory Diagnostics in Martinsried near Munich, as well as with Biomnis Laboratories in France and Genoma Group Laboratories in Italy, to help those partners offer non-invasive prenatal testing on the HiSeq 2500 platform.

According to Hanns-Georg Klein, CEO of the Center for Human Genetics and Laboratory Diagnostics, Illumina will transfer NIPT technology from its Verinata unit to his center, including not only laboratory protocols but also software and analysis methods, so all testing can be performed within Germany, which he said is important because of the country's strict data protection laws.

Both Ariosa and Natera currently ship samples from Germany to the US for analysis, but medical associations in Germany have warned that those firms might run into liability problems, he said.

Klein's laboratory plans to start offering its test in late August and plans to obtain accreditation for it in the fall. The test, which will have an out-of-pocket cost of €690, will cover trisomies 21, 18, 13, and Turner syndrome and will be initially available for above-average risk pregnancies.

In parallel, the center, in collaboration with Illumina and its partners in France and Italy, is planning a multi-center study of the test in Europe for low-risk pregnancies. For the purpose of that study, Klein's laboratory will offer the test at a reduced price.

Once LifeCodexx's test has gained full reimbursement status, he said, other NIPT providers in Germany will be able to get reimbursed for their tests as well, as long as they are accredited.

And while Sequenom is still in litigation with Ariosa, Verinata, and Natera over intellectual property rights, Illumina's tech transfer contracts with its partners includes "some indemnification," Klein said, adding that he believes his laboratory does not require a license to Sequenom's patents.

Klein's laboratory will offer its test through a consortium of prenatal centers, initially in the Munich area, which will include gynecologists and other prenatal specialists. "We think that this kind of testing has to be embedded into a complete medical workup for the pregnant woman and should be part of their medical care," rather than being offered in isolation, he said, and it will be important for women to understand the benefits and limitations of the test.

Overall, he is confident that NIPT will eventually gain more acceptance in Germany. "The medical professional societies are somewhat skeptical, [and] I think it will need more time here in Germany to get a breakthrough for this kind of testing," he said. "But I personally strongly believe in the future of non-invasive prenatal testing and I'm also convinced that the scope of the analysis we can do with this approach will widen in the next several years."

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