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New Providers Enter German NIPT Market While Reimbursement Remains Elusive

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NEW YORK (GenomeWeb) – Competition between providers of DNA-based noninvasive prenatal screening tests in Germany has increased over the last year, with several local laboratories that process samples within the country's borders entering the market, BGI offering its test through a partner, and other firms, including Premaitha Health, in the starting blocks.

While Germany represents just a fraction of the European market that is served by commercial NIPT providers, with a population of more than 80 million, and 715,000 live births in 2014, the country remains one of the largest markets for prenatal diagnostics in Europe.  

Prices in Germany for NIPT, which determines the risk of fetal trisomies and other chromosomal abnormalities, have plummeted over the last year, driven by competition and process improvements. For most women, the test remains an out-of-pocket expense, as it is not generally reimbursed by Germany's statutory health insurance, which covers about 90 percent of the population. Both statutory and private insurance have paid for the test on a case-by-case basis, though, in particular for women with above-average risk pregnancies.

Plans by the agency that determines reimbursement for new diagnostics and medical services to consider NIPT for an assessment have not advanced since 2014, but a decision is expected in the near future and may lead to the inclusion of NIPT into the reimbursement catalog within several years.

Overall, acceptance for NIPT in Germany — which was fiercely opposed by anti-abortion and patient advocacy groups when LifeCodexx, the first NIPT provider in Germany, launched its PrenaTest in 2012 — appears to be rising, and although sales numbers are hard to come by, providers are reporting increasing test volumes and higher awareness of NIPT among obstetricians and gynecologists.

Until last year, LifeCodexx, a spinoff from research service provider GATC Biotech, remained the only NIPT provider in Germany that analyzed samples within the country's borders. The firm developed its PrenaTest — called PraenaTest in Germany — in house but licensed intellectual property around the test technology from Sequenom.

"We have seen a doubling of the number of samples" over the last year, Michael Lutz, CEO of LifeCodexx, told GenomeWeb. The company, based in Konstanz in Southern Germany, near the border with Switzerland, derives about 50 percent of its business from its German core market, he said, though it also offers PrenaTest in many other countries, including Switzerland, Austria, Italy, Portugal, Eastern Europe, Turkey, and the United Arab Emirates.

The increased competition, he said, has helped raise the awareness for NIPT by general gynecologists. "Certainly, the competition has been heating up versus a year or two ago, but the market potential is still untapped, primarily for replacing invasive procedures," Lutz said, noting that adoption of NIPT by general OB/GYNs in Germany is still limited.

Prices for PrenaTest, which uses CE-marked software, have come down almost 25 percent this year, which Lutz attributed to internal cost reductions. Earlier this year, list prices ranged from €600 ($665) for a version of the test that only determines trisomy 21 risk and fetal sex to €900 for a tests that covers trisomies 21, 18, and 13, sex chromosomal aneuplodies, and fetal sex. The company also charged €100 for expedited testing services, reducing the turnaround time from eight to 10 business days to four to six business days. According to its website, current prices for the same tests now range from €440 to €660, with the additional €100 for fast service remaining.

The company is wrapping up a clinical validation study for a qPCR version of its test, which currently runs on a next-generation sequencing platform from Illumina, and plans to make the results public in the near future, Lutz said. LifeCodexx hopes to launch the new test, for which it is seeking CE marking, by the end of this year but is not disclosing yet whether it will perform the test in its own laboratory or license it to others.

In addition to LifeCodexx, Ariosa Diagnostics — acquired by Roche last year — has been offering its Harmony test in Germany through Sonic Healthcare, and Natera its Panorama test through Amedes. Both Sonic and Amedes operate several clinical diagnostic laboratories across Germany and have been sending samples from Germany to Ariosa's and Natera's US clinical laboratories for analysis. Recently, they were joined by BGI, which last month started offering its NIFTY test through a partner laboratory in Hamburg, MVZ Laboratory Dr. Fenner and Colleagues, which sends patient samples to BGI's clinical laboratory in China.

But amid uncertainty whether liability insurance of OB/GYNs permits doctors in Germany to order tests that send patient samples overseas for analysis, two other laboratories started offering NIPT locally this year, providing German doctors and their patients with additional options.

The Center for Human Genetics and Laboratory Diagnostics (MVZ), based in Martinsried near Munich, has been offering its Prenatalis test routinely since January, after announcing a partnership with Illumina last summer to transfer that company's Verifi test technology to its laboratory.

According to the center's website, Prenatalis, which uses Illumina's HiSeq sequencing platform, costs about €430 for a version that tests for trisomies 21, 18, and 13 and €545 if sex chromosomal aberrations are included. Turnaround time is eight to 10 business days, which can be reduced to five business days for an additional fee of about €100.

According to CEO Hanns-Georg Klein, the center promotes offering NIPT as part of comprehensive pregnancy care rather than as a standalone test and collaborates closely with prenatal service centers. He pointed out that Prenatalis is currently the only NIPT that has been accredited by Germany's national accreditation body, DAkkS.

The center mostly serves patients from German-speaking countries, but the firm has plans to offer Prenatalis in Eastern Europe and the Middle East and already has collaborations in Romania, Russia, and Dubai, he said.

The latest local laboratory to offer NIPT in Germany is Cenata in Tübingen, a spinoff from genetics diagnostics firm CeGaT. The company licensed Ariosa's test from Roche and was the first laboratory to offer the Harmony test outside of Ariosa's US laboratory, starting testing services in May. Pricing for the Harmony test, which runs on an Affymetrix microarray platform and uses a CE-marked analysis algorithm, ranges from about €400 for trisomies 21, 18, and 13 to €450 for trisomies 21, 18, 13, sex chromosomal abnormalities, and optional sex determination. The test has a turnaround time of four to six business days, but according to Co-CEO Dirk Biskup, it is now down to five business days.

Biskup said Cenata has seen good uptake of the test, requiring it to double its capacity and establish a second pipeline for processing samples, which includes a Tecan liquid handling system and an Affymetrix GeneTitan. "The overall acceptance of NIPT is increasing, even in Germany, where it was seen very critically by some people for ethical reasons," he told GenomeWeb.

Cenata currently receives 60 to 90 samples per day, mostly from Germany, the company's core market, but the company is currently expanding its services into Austria, Switzerland, Poland, Turkey, Dubai and the Gulf states, where it already offers Harmony, as well as to Nordic countries, where it plans to offer the test within the coming months, Biskup said.

While German providers are expanding to other countries, new players are expected to enter the German market over the coming year. UK-based Premaitha Health, for example, which earlier this year launched its Iona test, the first CE-marked in vitro diagnostic NIPT in Europe, plans to either open a laboratory in Germany or to partner with an existing clinical laboratory early next year, according to Andreas Eckelt, a Premaitha consultant.

Premaitha has already sold the Iona test, which runs on Thermo Fisher Scientific's Ion Proton sequencer, to laboratories in the UK, Poland, and Switzerland, and provides testing services out of its own laboratory in Manchester, but the company is keen on entering the German market. "It's the biggest market in diagnostics in Europe, so of course it is important," Eckelt said. "We have significant efforts to get something established as soon as possible."

Another company, Multiplicom of Belgium, announced this month that it received CE-IVD marking for its NIPT, called Clarigo, which assesses the risk of trisomies 21, 18, and 13 and relies on targeted NGS. According to the firm's marketing director for prenatal products, José Tijsen, the German market "is indeed important for Multiplicom" but he provided no further information for the company's plans to enter this market.

Reimbursement remains in limbo

Meanwhile, reimbursement of NIPT by Germany's statutory health insurance remains in limbo. In 2014, the Joint Federal Committee (G-BA), a stakeholder committee that determines which new medical services and diagnostics become reimbursable, said it was considering noninvasive molecular genetic prenatal testing for fetal trisomy 21 detection for an assessment program to learn about its benefits and risks. LifeCodexx had applied to the G-BA in 2013 to have its test considered for the program, called "Erprobungsrichtlinie," which was recently introduced in Germany to streamline the process of general reimbursement decisions.

This January, in response to an article about NIPT in the German weekly Die Zeit, the agency clarified that NIPT has the potential to replace invasive testing, but that it has not decided yet whether it plans to study it further. G-BA said that discussions on admitting NIPT to the assessment program are ongoing. Only if it gives the green light for this can a trial of the test go ahead, it said, and statutory health insurance will cover the cost of the test for trial participants. After the conclusion of the study, G-BA would make a final decision on whether to add the new method to the catalog of services covered, which industry experts estimate can take more than a year.

LifeCodexx's Lutz said that this would still be faster than the regular process, which industry insiders say can take up to 10 years. However, nobody knows how the G-BA will decide, though it is expected to do so soon, and companies are not getting their hopes up too high. "If the decision [to go ahead with a trial] is going to be made tomorrow, we are going to be ready. We are prepared and have lined up everything, but nobody here is waiting for the decision," Lutz said. "We keep ourselves busy; we are not waiting for this thing."

Switzerland is currently the only country in Europe whose mandatory health insurance system is reimbursing NIPT for high-risk pregnancies, a decision made this summer after less than two years of deliberations, and Lutz said the effect on LifeCodexx's business has been modest so far. "It has started to bring the number of tests up, but it's certainly not skyrocketing from where it was before," he said.

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