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Premaitha to Launch First CE IVD Noninvasive Prenatal Test in Europe in Early 2015

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NEW YORK (GenomeWeb) − As a number of companies have started offering next-generation sequencing-based non-invasive prenatal testing services in Europe, Premaitha Health, a UK-based startup, is pursuing a different strategy: offering a CE-marked in vitro diagnostics NIPT product to local clinical laboratories that already offer other prenatal screening tests.

Earlier this month, Premaitha, based in Manchester, raised £7.2 million ($12.3 million) for the development of its Iona test through an Open Offer and started trading on the AIM platform of the London Stock Exchange, following a reverse takeover by investment firm ViaLogy.

Premaitha grew out of a predecessor, Zoragen Biotechnologies, that started out developing different prenatal screening methods. After resetting its strategy, and under new management, Zoragen changed its name to Premaitha last year and moved from Cambridge to the Manchester Science Park. Prior to its latest funding, about £3.5 million had been invested in discovery projects, according to CEO Stephen Little. The company has under 50 employees at the moment but is at a stage of "rapid expansion," he said.

Little, the former CEO of DxS, which was acquired by Qiagen in 2009, predicts that within the next few years, all existing prenatal screening will switch to NIPT, representing a "huge opportunity" for test providers. Unlike the US, where large reference laboratories dominate the market, the European clinical testing industry is heterogeneous and fragmented, he said, with about 600 laboratories offering some type of prenatal screening today. Premaitha plans to sell instruments and test kits to those laboratories, enabling them to offer NIPT in house.

"As far as we are aware, we will be the first CE-marked in vitro diagnostic product into the [NIPT] market," Little said. "There's an awful lot of laboratories in Europe who don't want to see their screening business disappear, would love to offer a new test, [but] don't have the technical expertise or wherewithal to do this," he explained. "What we try to do with our product is to make it simple enough and straightforward enough that any laboratory with skilled medical techs, a normal clinical laboratory, can install the instrumentation and offer the test."

Premaitha's Iona test, which it plans to start selling as a CE-marked IVD starting in early 2015, will initially screen for trisomies 21, 18, and 13, and later add sex chromosomal aneuploidies. Like other NIPTs, it will sequence cell-free DNA from maternal plasma, which contains both maternal and fetal DNA, to determine chromosomal imbalances. The test will use a genome-wide rather than a targeted approach.

It will run on the Ion Proton sequencer, which customers will need to purchase, along with other instrumentation from Thermo Fisher and other third-party providers for DNA extraction, library preparation, and emulsion PCR. Premaitha is discussing potential agreements with those providers, Little said, adding that "we've chosen the best platform for this application as we see it at the moment." Most of the other NIPT test providers currently run their tests on an Illumina sequencing platform.

According to the firm's website, the Iona test will have a turnaround time of two to three days and a throughput of about 200 samples per week, using one Ion Proton system.

Premaitha will provide its customers with CE-marked reagent kits – some reagents will come directly from the instrument vendors – as well as CE-marked "medical grade" analysis software, and protocols.

The company is currently building a demonstration lab in Manchester to showcase the test and workflow. Once a customer has signed on and acquires the necessary instrumentation, a team from Premaitha will set up the test in the customer's lab and provide ongoing technical support. This will include a back-up service by Premaitha's own clinical laboratory, which can temporarily step in and analyze samples for customers facing technical problems.

Verification and validation studies of the test are ongoing, and Premaitha is hoping to get it CE-marked by the end of the year. For those studies, the company has been working with unnamed clinical collaborators in the UK.

To achieve CE marking, the firm's technical files will need to be reviewed by a so-called notified body – an assessment organization accredited by a EU member state – to ensure the product meets certain standards, Little said. It may not be necessary to run the CE IVD test on a CE-marked sequencer, he added – the Ion Proton is currently not CE-marked.

The test will initially be validated for high-risk pregnancies, but Little expects that like other NIPT tests, it could quickly be expanded to general screening.

He declined to say whether Premaitha has licensed intellectual property from Sequenom or other NIPT providers. LifeCodexx, a NIPT service provider in Germany, for example, licensed patents from Sequenom prior to offering its test. "We can be confident that when the test goes out the door, the customers will be able to run it without any concerns" about IP, Little said.

He also declined to provide a list price for the test and equipment but said Premaitha will offer it at a price that will allow laboratories to "make a reasonable margin on their assay."

Premaitha plans to launch the Iona test initially in Europe – including the UK, Germany, France, Spain, and Italy – followed by the Middle East and Asia. It currently has no plans to offer it in the US because of the high regulatory hurdles set by the US Food and Drug Administration for IVDs. "For a lot of diagnostic tests, if you said 'we're not going to sell this in America,' it would be the case of death for the business," Little said. "But with NIPT, the opportunity is so substantial, it's an excellent business to be had in Europe, the Middle East, and Asia, and then we shall see where we get to in America in the next couple of years."

Reimbursement for the test will differ between countries. In the UK, for example, Premaitha expects private laboratories to adopt the test first, and the government's National Health Service to come on board later.

Premaitha's main competitors for the Iona test will be laboratories developing their own NIPT assays, as well as NIPT service providers offering their tests in Europe, such as Sequenom, Ariosa, LifeCodexx, Natera, and Illumina, which recently started to transfer its Verinata test technology to European partner laboratories.

Little said he has seen significant interest for Premaitha's test from European clinical laboratories already, but some labs appear to prefer in-house developed tests over CE-marked IVD products. Hanns-Georg Klein, CEO of the Center for Human Genetics and Laboratory Diagnostics in Germany, for example, which recently partnered with Illumina to bring the Verinata test in house, said CE IVD kits are often several times more expensive than research consumables, and CE IVD instruments are pricier than research versions as well.

Also, the CE IVD label "does not guarantee a better quality of the test," he said, adding that in his experience, it can even be the opposite. The CE IVD mark also does not limit a clinical lab's liability under German law, so the lab still needs to verify the quality of the test.

In addition, running a CE IVD test does not ensure a lab's staff can interpret the test results adequately, he added, whereas accreditation of an in-house test requires this competence. "It makes quality even worse, because people with little knowledge may think that they can start offering a test, just because it has a CE IVD label," he said.

Premaitha, once it has launched the Iona test as a CE IVD product, plans to venture into other diagnostic areas, focusing on circulating DNA biomarkers, for example, for early cancer detection or cancer monitoring. "We're not going to go looking for new biomarkers, but I think we will be a company that once a new biomarker has been identified can then translate that into a product that can be readily and broadly distributed," Little said.

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