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BBI Solutions Courts Diagnostics Firms with New Signal Enhancement Technology

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NEW YORK (360Dx) – BBI Solutions, a UK company that offers biological reagents and immunoassay services to the diagnostics industry, recently rolled out a new technology that it claims can improve signal detection.

The Crumlin, Wales-based firm is positioning the technology, called Morffi, for use in lateral flow immunoassays, particularly in infectious disease diagnostics, such as influenza tests.

Morgan West, an inventor of the Morffi technology and new product development lead at BBI Solutions, said that the reclassification last year by the US Food and Drug Administration of rapid antigen flu tests to Class I devices from Class II devices, has meant that flu tests can result in false negatives in no more than 20 percent of tests, putting pressure on manufacturers to improve their detection rates. The company believes its technology can improve the results of lateral flow immunoassays for flu testing, making BBI Solutions a potential partner for firms that wish to license Morffi.

"In general, there is a lot of interest from companies that have flu tests on the market in trying to drive better sensitivity," West said. "At the moment, we see especially American companies with tests on the market that are slightly worried about these changes and are working hard to improve their tests as a result."

BBI Solutions was established in 1986 to commercialize gold nanoparticle technology developed at Cardiff University. The company sells gold reagents, antibodies, antigens, and enzymes to diagnostics companies while offering them original equipment manufacturing services, as well.

"We run a lot of OEM diagnostic contracts where we develop tests for different diseases for other customers," said West. The firm's partners then sell the tests under their own brands. BBI Solutions maintains a toolbox of technologies it can offer its clients. Its Morffi technology is one of them. "Our main aim is to improve what we have already," said West. "The flu virus is quite topical," he noted.  "If we can offer higher sensitivity, there are less chances for mistakes."

West developed Morffi together with fellow BBI Solutions scientist Ffion Walters — hence the name Morffi — about 18 months ago. The team fashioned the technology as an alternative to conventional gold conjugation methods, which they believed were limiting the ability of binding partners in lateral flow immunoassays to bind to the target analyte.

As West noted, lateral flow immunoassays rely on the interaction between the target analyte and binding partners, such as antibodies. As part of the assay, a second antibody is conjugated to a label, such as a gold nanoparticle, and when both antibodies bind to the target analyte, the positive result is read as a colored line. A blocking agent is also employed to bind to sites unoccupied by the label in order to prevent non-specific binding.

Companies typically use a blocking agent called bovine serum albumin to accomplish this, though it can cross-react with other antibodies, reducing the effectivity of the assay, according to West. BSA blockers are currently marketed by a number of firms, including Thermo Fisher Scientific, Vector Laboratories, SurModics, and others. Morffi, in contrast, is a synthetic blocker that the firm maintains can reduce these issues, he said, enhancing binding between the label and the target analyte to improve assay performance.

The company describes its approach in a white paper on its website.

"By using that smaller blocker we have been able to achieve a lower limit of detection," said West. He noted that Morffi was first introduced to customers in November. BBI Solutions is now offering Morffi within its contract development team and working with potential clients that would like to trial it.

"Some of the bigger diagnostics companies that develop their own tests have come in and we have conducted evaluations in substituting our Morffi conjugate into their test," he said. "We look at our conjugate versus their conjugate and show them that this is what it can do." He said that BBI Solutions in particular has seen interest from larger customers who do their own development in house as opposed to outsourcing it to firms like BBI Solutions.

"They see the potential, they like the technology, and they like that they can take it in house," he said. "It's not an outsourcing of everything they do. "

West said that BBI Solutions has now demonstrated the use of Morffi with diverse targets using monoclonal and polyclonal antibodies in sandwich and competitive assay formats. The company has also implemented Morffi in protein antibody aggregation assays. "Anywhere where you have nanoparticles and you want to block sites to produce a stable conjugate in order to produce a sensitivity boost, this can be applicable," he said.

While companies that offer flu tests are a target market for the firm, West said that Morffi could be implemented in other immunoassay infectious disease tests, as well as other indications, from cardiac panels to drugs of abuse.

"It can be used anywhere where sensitivity enhancement would be an advantage," said West. "Anywhere where there are existing tests that would benefit from picking up those concentrations."