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Elucigene Diagnostics to Take US-Specific CF Panel to FDA Next Year as International Sales Spike

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NEW YORK (GenomeWeb) – Elucigene Diagnostics, a Manchester, UK-based molecular test provider, will seek US Food and Drug Administration clearance next year for a cystic fibrosis screening assay specific to the American population.

CEO Mark Street-Docherty said that the multiplexed PCR kit will target mutations associated with cystic fibrosis that are highly prevalent in the US.

The rollout is part of the British firm's strategy of serving various regional markets with products tailored to the genetics of the people who live there. Elucigene currently sells kits for cystic fibrosis screening in the UK, France, Germany, Italy, and Spain, all of which are CE-IVD marked. Two of them — CF-Italia and CF-DE — were launched earlier this year.

Encouraged by its success in international markets — which now generate more than 80 percent of Elucigene's revenues — the firm has turned its focus not only to the US, but to the Middle East and Africa as well.

"Our big build, and our next step company-wise, is to take our first product through the US FDA," Street-Docherty said. "All of our current cystic fibrosis products, which account for about 55 percent of our sales, have taken into account regional variation in genetics," he noted, crediting Elucigene's success to "taking a region-specific approach to serving those markets."

All of Elucigene's CF products target mutations in the cystic fibrosis transmembrane conductance regulator gene, and are sold as PCR kits for use on capillary electrophoresis instruments sold by Thermo Fisher's Applied Biosystems business. The question for the market, however, is which mutations to target.

"Depending on your ethnic background, the predominant mutation you're looking for would be very different," said Street-Docherty. "Traditionally, if you didn't know what the person's ethnicity was, you would take [a next-generation sequencing] approach, which looks at the whole gene, but is prohibitively expensive for most people," he said. Indeed, Elucigene sees its products, which Street-Docherty claims typically cover most of the mutations in each given population, as an affordable alternative to sequencing-based approaches on the market today.

"It's a cheaper way to test people," he said. "And it ensures that the more difficult and expensive analysis is reserved for individuals carrying very rare mutations."

Elucigene has been selling its UK population-focused CF kit in Britain, Canada, and Australia and has done "extremely well" in each of those countries, but it's expansion to the US will be a new stage for the firm as it looks to further raise its international portfolio. It will also be the first assay the company submits to the FDA. Street-Docherty said that Elucigene hopes to have a cleared kit on the clinical market within the next 18 months.

That dialogue with the FDA represents more than just the ability to sell a test to US laboratories. Elucigene has positioned itself as a company that is savvy enough to develop and launch molecular diagnostics for different regions, not only by making products specific to them, but by being well-versed in engaging the local regulatory authorities. Elucigene now claims to be operational in 50 countries, either directly or through partners, and a panel for countries in the Middle East and North Africa, dubbed CF-MENA, should hit the market in 2019.

As Street-Docherty described it, Elucigene spent "a lot of time researching different regional markets" following a management reshuffle in 2013, which saw Street-Doherty take the helm of the company. With most of its money made outside the UK, and a 30 percent year-over-year revenue increase according to a statement made last week, the privately held firm wants to continue that trajectory.

When Elucigene begins selling its CF kits into the US market, the company expects its offering to be a "replacement technology" for conventional tests. "That falls into the fact that we are faster and cheaper than the existing technology on the market," he said. But as it looks further to the Middle East, Africa, and Asia, it's possible that the subject populations may have never been served by a cystic fibrosis test at all.

"In some cases there is no product on the market that suits the needs of those individuals," said Street-Docherty. In such cases, Elucigene's offering would represent an introduction to molecular testing for those laboratories.

That's also the case for some markets in terms of Elucigene's reproductive health business. Elucigene currently offers three reproductive health tests: the QST*R-PL Pregnancy Loss Kit for invasive prenatal aneuploidy screening, which is run on the Applied Biosystems 3130xl Genetic Analyzer; its quantitative fluorescence PCR-basedMale Factor Infertility Kit; and MFI-Yplus, an extension assay testing 11 more markers for characterizing Y-chromosome microdeletions. The latter two are designed for use on Thermo Fisher Scientific's CE Genetic Analyzer instrument.

"We have quite a mature market in the European sector, but we have an undeveloped business that we get through the Middle East and the Far East, and then there is South America, which is a whole step behind where Europe was maybe 10 years back," said Street-Docherty.

While he noted that noninvasive prenatal testing has to some extent reduced demand for Elucigene's reproductive health assays, the company last year partnered with Konstanz, Germany-based LifeCodexx to offer LifeCodexx's NIPT offering, PrenaTest, to patients in the UK and Ireland.

"We are marrying our technology with the new technology that is coming out," said Street-Docherty. "Prenatal testing is in a state of flux across the globe."

Product realization services

Lifecodexx is what Elucigene now considers a PRS-partner, or a company it is cooperating with through its new product realization services, a business model where Elucigene offers access to its product development and manufacturing expertise, as well as its experience launching tests in different international markets to up-and-coming molecular diagnostics partners.

While PRS was officially launched in September 2016, Street-Docherty said that the company had been working with other companies and groups on an ad hoc basis before that, typically fielding queries from three or four potential collaborators per month.

"It just crystallized," said Street-Docherty of PRS. "If you think about what a lot of smaller companies are doing, it's very focused on just bringing their own technology to market and being very reliant on that," he said. "We have moved into a sector where we can look into how we can support people bringing things to market, in a way that would benefit us and them."

As such, Elucigene will not partner with just any company that approaches it. It is looking for mutually beneficial opportunities, looking for products that would appeal to its existing customer base. And the kinds of services it provides differ from project to project, ranging from contract manufacturing, selling the resulting products through its own sales force, or, if they come into the picture earlier in the development process, even royalties on sales, or an equity split.

"It depends on where in the development cycle Elucigene steps in," said Street-Docherty. "Mainly we would look to sell products cobranded or with an Elucigene brand," he said.

Another PRS partner is Tubascan, a spinout of the department of medical microbiology and infection control at VU University Medical Center in Amsterdam, the Netherlands. Tubascan Founder Servaas Morré said the company is working with Elucigene to bring to market a rheumatoid arthritis companion diagnostic called PreselectScan, and a test for triaging female infertility patients called TubaScan. Both have been funded with 3.1 million ($3.7 million) in grants from Eurostars, a European program that funds small- and medium-sized enterprises that perform R&D.

Morré is head of the Laboratory of Immunogenetics at VUMC. He described Elucigene's PRS offering as "unique" in the European molecular diagnostics market. He noted that Tubascan intends to update its TubaTest content in the future to include SNPs that are specific to different ethnic groups, in order to better serve regional markets, just as Elucigene is doing with its CF assays.

"This is the reason why Elucigene is such a good collaborator for us," Morré said. "They know the business, they have the sales expertise, have the knowledge for genetic assay development, and know what is needed to keep up to date with those assays."

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