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UK Firm Smiths Seeks to Enter MRSA Molecular Dx Market; Eyes Partnerships for LATE PCR Tech

NEW YORK (GenomeWeb News) – Watford, UK-based Smiths Detection, a newly formed unit of Smiths Group, recently announced that it is seeking partners to develop tests for its Bio-Seeq molecular diagnostics instrument, and it hopes to have hospitals in the UK early next year evaluating a multiplex assay for methicillin-resistant Staphylococcus aureus.
Although the firm would be entering the MRSA market a couple of years after molecular diagnostic offerings from Cepheid and Becton Dickinson, Smiths believes its multiplexing capabilities and PCR technology that it has exclusively licensed from Brandeis University will give the company an advantage over the established players.
Smiths Detection was created based on the Smiths Group’s experience in developing portable testing equipment for military applications. The first product for Smiths Detection, the Bio-Seeq platform, is initially being marketed to government veterinarians doing outbreak containment and monitoring work for diseases such as foot and mouth disease and avian influenza.
“With this technology, we realized that the portability provides advantages for other applications, and the first application other than veterinary that we’re looking at is hospital-associated infections,” said John Czajka, director of business development for Smiths Detection.
“We realized that there are certain requirements for testing – pre-admission testing for MRSA, some need for portable clinical diagnostics,” he told GenomeWeb Daily News in a recent interview. “So we’re using the same core technology that we developed for the veterinary market to develop instrumentation for the clinical diagnostics market.”
The MRSA assay is expected to be the first test developed and sold by the firm for human health purposes. In addition to its plans for working with hospitals in the UK, Smiths hopes to find some US hospitals that also would evaluate the assay for MRSA screening.
Czajka said that he believes Smiths’ assay will be easier to use than the Cepheid test, requiring less sample prep work, and “we’re developing a slightly more complex PCR assay for MRSA, which will have more genetic targets in it because of our multiplexing capability, and that should reduce the number of false positives that are seen in MRSA testing.”
He added, “We think the multiplexing ability will give us an advantage when we look toward in other hospital-associated infections, and looking at antibiotic-resistance genes as well to detect organisms.”
The company began working with researchers at Brandeis in 2004 and holds the exclusive rights to the university’s Linear After The Exponential Polymerase Chain Reaction, or LATE, PCR technology. It also has been funding the lab at the university doing assay and technology development related to the technology.
“I started working with the Brandeis group in 2004, and as we worked with them to evaluate the technology, we realized it had significant performance advantages over conventional symmetric PCR and real-time PCR,” said Czajka. He said among those advantages is that the technology can do high-quality endpoint analysis, which eliminates the need for real-time PCR and the associated licenses.
He also said that LATE PCR’s sensitivity is “often as good if not better than real-time PCR.” But, he said the biggest advantage, in the company’s view, is its multiplex capability.
“It’s got an inherent capability to withstand more primer and probe sets within a multiplexing reaction, so just from a pure number of primers and probes within a reaction, we think we can get higher numbers of targets within a reaction using LATE PCR,” said Czajka.
He said that while most real-time PCR multiplex tests run about four to 10 targets per assay, the LATE PCR assays will “be on the order of 20 to 50.” In addition, he said, “we can also do quantitative endpoint detection. So where most endpoint detections are qualitative, if we need to, we can quantitate the initial copy number of targets.”
In addition to the Bio-Seeq instrument, Smiths has developed an automated sample preparation consumable that will enable a “sample in, answer out” workflow. Czajka also noted that the Bio-Seeq and sample prep units will be open platform.
“In addition to Smiths developing and selling assays for various markets, Smiths is interested in sublicensing the LATE PCR technology and selling the reagent plastics so that a company could make their own assays and sell them directly to customers if they choose to, and then the customers would just buy the sample prep units from Smiths to run on the Smiths instrument,” said Czajka.
Smiths also is seeking partners to develop assays that the firm would be interested in marketing directly to consumers. The firm intends to offer assay developers a turnkey package of intellectual property required to market and run LATE PCR assays. “So, a company could come to Smiths and basically sign one license deal and pay one check for the license or royalty and not have to negotiate all these smaller licenses for the associated IP,” he said.

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