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Lab21 to Develop Aspergillus Assay for Second IVD Company


By Ben Butkus

Lab21 said this week that it has entered into an agreement with an undisclosed in vitro diagnostics company to develop, manufacture, and distribute a diagnostic assay to detect Aspergillus species for the partner's real-time PCR platform.

Under the agreement, Lab21 will contribute its molecular diagnostic development resources and intellectual property in the fungal diagnostics area to develop and manufacture the new Aspergillus test as OEM reagents for the partner platform.

Berwyn Clarke, chief scientific officer of Lab21, told PCR Insider in an e-mail that the "the technology will be used globally on the partner platform."

Clarke declined to comment on the identity of the partnering IVD firm, but the company noted in a statement that it was a "top-10 IVD player."

The company noted that the new agreement is similar to one it made in August with BD Diagnostics. Under that partnership, the companies are working together to develop a molecular test for Aspergillus on the BD Max Open system (PCR Insider, 8/4/2011). That assay is also destined for marketing in both Europe and the US, the companies said at the time.

Lab21, which is based in Cambridge, UK, and has offices in South Carolina, provides diagnostic products and services in the areas of blood bank screening, medical diagnostics, and drug discovery.

The company acquired Manchester, UK-based fungal molecular diagnostic firm Myconostica last May for an undisclosed amount (PCR Insider, 5/23/2011).

Myconostica had previously developed a process for extracting fungal DNA from human samples, as well as the real-time PCR test for Aspergillus. Lab21 currently markets the technologies in Europe as the MycAssay Aspergillus molecular diagnostic kit, which has been CE marked and validated for use on several real-time PCR platforms, including the Cepheid SmartCycler, Life Technologies ABI 7500, Roche LightCycler 2.0, and Stratagene Mx3000 series.

Clarke noted that the approved MycAssay Aspergillus test kits "are our own brand," while those under development with IVD collaborators represent a "next generation of products" that the partners will offer under "their own brand and provide content on their own platform."

He also noted that the development deals with BD and the new partner and the process of validating MycAssay on various real-time PCR platforms are generally similar. "Each platform is different so [it] needs separate development, optimization, validation, and regulatory approval," Clarke said. "Many platform providers are seeking to extend their menus and we provide the IP and experience for Aspergillus, in this case, to enable that."

One potential IVD partner for Lab21 is Abbott. In February, Lab21 hired Fraser Logue, a former Abbott executive, as its group director of quality, regulatory affairs, and operations excellence (PCR Insider, 2/23/2012). However, Abbott has already developed tests for several species of Aspergillus on its Plex-ID system.

Other potential IVD partners that currently market real-time PCR-based diagnostic systems but do not market molecular assays for Aspergillus include Cepheid, Roche, Gen-Probe, and Quest Diagnostics' Focus Diagnostics business.

Lab21 said that its real-time PCR test platform "is becoming increasingly well-adopted within clinical diagnostic laboratories worldwide;" and noted that recent independent studies have validated both Lab21's Aspergillus and Pneumocystis assays.

"We expect the new [Aspergillus] assays to be significant components of the growing menu of our partner’s molecular diagnostic portfolio," Clarke said.

Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.