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NUI-Galway Group Ramps up Commercial MDx Efforts via Spinout Firm, Company Partnerships

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The Molecular Diagnostics Research Group at the National University of Ireland, Galway, has ramped up its commercial activity in recent months in an attempt to market the group's innovations — particularly novel nucleic acid targets for infectious diseases — as well as its assay design and validation prowess.

Terry Smith, a professor of biomedical engineering at NUIG and director of the Molecular Diagnostics Research Group, in November co-founded and currently directs Advanced Molecular Systems, or AMS, an NUIG spinout company that provides molecular diagnostics R&D and consultancy services, and aims to eventually provide molecular diagnostic testing services.

In addition, in October the NUIG group recently saw the successful commercialization of one of its assay technologies, as partner SeroSep, a Limerick, Ireland-based clinical diagnostics firm, launched the EntericBio Realtime Gastro Panel 1, a multiplexed real-time PCR assay that uses nucleic acid targets discovered and validated at NUIG.

And finally, the NUIG group has finished transferring a number of molecular assays for bacteria, fungi, and parasites to Beckman Coulter, which plans to commercialize them as part of the test menu for its DxN molecular diagnostics system, perhaps as soon as the end of this year, Smith said.

Smith discussed these initiatives and other business development activities at the NUIG group and AMS in an interview with PCR Insider last week at Cambridge Healthtech Institute's Molecular Medicine Tri-Conference in San Francisco.

Of NUIG's recent commercial activities, its partnership with Beckman Coulter is most prominent. The entities originally announced they would collaborate for molecular diagnostic development in January 2008.

At the time, Beckman said that the partnership would focus on a variety of infectious disease assays, taking advantage of the NUIG group's primary area of expertise, and that the diagnostics platform would likely be launched in 2010.

That launch date, however, was pushed back several times as Beckman muddled through financial woes and layoffs, and was eventually acquired by Danaher.

Last week, Smith disclosed that the NUIG group has successfully developed and transferred to Beckman 31 singleplex and seven multiplex assays for various bacterial, fungal, and parasite targets; and has evaluated process controls and sample preparation procedures.

Smith also said that Beckman has indicated that it will launch DxN by the end of this year.

"Their instrument is pretty much ready to go … and they've certainly been publicizing [it] at conferences. They've got a series … of assays that are going to be launched one after the other … and the plan is for the first tranche of their assays to be launched by Q4 2013. I'm not certain whether any of [NUIG's] assays will be launched this year, because they've got a mixture of bacterial and viral assays."

Smith noted that the NUIG group has been Beckman's only external assay development partner on the project, with the rest of the assay content being developed at Beckman.

"We were focused on a certain large number of bacteria and some fungi; and they were doing some viruses and bacteria in parallel, and that's where we've worked together," Smith said.

Specific details of the DxN system, including its initial test menu, are still under wraps, although the company has previously said that the platform will be "sample-to-answer." A Beckman spokesperson this week declined to confirm the planned launch date, but noted that the company was "making good progress on the system."

Officials from parent company Danaher said at the firm's investor day in December that the DxN is expected to launch by the end of 2013, likely in Europe, with a planned US regulatory filing in 2014. And at the JP Morgan Healthcare conference in San Francisco in January, Danaher President and CEO Lawrence Culp said that DxN was at least one year away from a launch in the US, although Beckman had demonstrated an early-stage version of the platform in Europe.

Culp also said that development of the platform remains a "major effort" and that Danaher continues to funnel more than $40 million in R&D annually into Beckman's molecular diagnostics business. He also underscored hepatitis C and hospital-acquired infections, including Clostridium difficile and methicillin-resistant Staphylococcus aureus, as key assay targets.

The commercialization of the Beckman assays will undoubtedly be a boon to the NUIG group, but in the meantime the group has made strides in diversifying its commercial activities.

Smith said that the group forged a partnership with SeroSep a few years ago after the company, which had traditionally provided clinical chemistry reagents for gastrointestinal diseases to hospital labs, decided to quickly move into the molecular diagnostics field.

"Without having any expertise in molecular diagnostics or molecular testing, they came to talk to us, and essentially contracted us as their molecular diagnostics partner for assay design and development," Smith said. "We provided the targets and the assay development expertise … and they licensed various technologies, such as detection technologies and fluorescent probes, from other sources."

In October, SeroSep launched the first product from this partnership, the EntericBio Realtime Gastro Panel 1, designed to simultaneously screen for Salmonella, Shigella, Campylobacter, and toxigenic Escherichia coli from patient fecal samples in about three hours' time.

The company also said recently that in November the Royal Free Hospital of London became the first UK site to routinely use the assay, improving its turnaround time for fecal pathogen testing from about two days to three hours.

SeroSep has not disclosed additional details about the assay, such as the detection chemistry and the real-time PCR platforms for which it has been validated. Company officials could not be contacted prior to publication of this article.

Smith said that overall the NUIG group has developed nine singleplex and two multiplex assays for SeroSep, and that researchers from the group will continue to do development work for the company. However, the bulk of this work will be performed through AMS, the recent NUIG spinout.

"We've got a very good relationship with SeroSep, and after we worked with them on the first round of assays … they then wanted a second round of assays developed," Smith said. "More recently, in the last [several] months, they preferred to work with AMS as a partner as opposed to us as a university, because there is a certain cleanliness working with another company — it simplifies issues with intellectual property."

SeroSep is currently AMS' only client, but Smith said that part of the reason for attending the Molecular Medicine Tri-Con was to attempt to identify additional business partners.

Further, he noted that while AMS' first priorities are to serve as a contract research and assay development partner to other companies, as well as a conduit for commercializing inventions from the NUIG Molecular Diagnostics Research Group, the company has additional plans to be a diagnostic test provider.

"The other strand to AMS, which is really going to take us some time to build up … is that we also plan to be … a testing service provider for … genomic-based tests," he said. "Particularly in [Ireland and Europe], we see ourselves providing capability in … next-generation sequencing-based mutation determination linked to cancer therapy."

He said that neither the NUIG group nor AMS conduct a significant amount of sequencing in house, but that they use NGS data for biomarker discovery and validation. Further, both the group and the company plan to branch out into virus assay development.

"Our focus was on identifying targets that were present in bacteria and fungi … and viruses don't have the same type of genome [such that] you can identify the same types of markers. So we had stayed away," he said. "Whereas with AMS, as a service provider to companies, we can design assays for viruses as long as the target sequences are publicly available, or the company we're working with has licenses to use those."

Other recent activities within the NUIG Molecular Diagnostics Research Group include the development and validation of a two-stage multiplex real-time PCR assay to identify all the members of the Mycobacterium tuberculosis complex (PCR Insider, 5/24/2012); and its involvement in an international consortium funded by the EU's Seventh Framework Program to develop a sample-to-answer diagnostic system to rapidly diagnose respiratory tract infections, specifically pneumonia.

As part of that latter effort, called the Rapid Identification of Respiratory Tract Infections project, the group will receive nearly €1 million as part of a total €6 million grant, and will partner with University College London; France's Genewave and Assistance Publique Hopitaux de Paris; and Finland's Mobidiag.

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