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Lab21 targets fungal infections
July 2011
by Lloyd Dunlap  |  Email the author


CAMBRIDGE, U.K.—Lab21 Ltd., a personalized medicine and clinical diagnostics company, has made its sixth acquisition in the past two years with the purchase of Myconostica Ltd., a molecular diagnostic company focusing on the diagnosis of clinically significant fungal infections. The financial terms of the deal were not disclosed.
The acquisition of Myconostica expands Lab21's growing proprietary diagnostic portfolio and will provide the company's first set of nucleic acid-based assays. It also provides manufacturing capabilities for Lab21 from which it plans to further develop and produce its range of new biomarker assays.
In addition to developing global sales of Myconostica products, Lab21 will also be launching the Myconostica fungal testing services from its new reference laboratory in South Carolina as well as its laboratory in Cambridge.
Current fungal diagnostic tests based on culturing techniques have significant clinical limitations, and Myconostica says its molecular diagnostic approach provides more rapid, sensitive and specific information, which together will improve clinical outcomes.
"Lab21's growth strategy is based on the classical acquisition model," says Graham Mullis, Lab21's CEO. "Myconostica has been on our list for two years or more, and we are delighted they are now on board. The company's products complement our infectious diseases portfolio and help position the company in a large market where there are significant clinical challenges."
Mullis notes that his company's newest acquisition will soon announce two new products and has a facility in South Carolina—now unmanned—that is available as needed for growth.
Myconostica, also based in the United Kingdom, was spun out from the University of Manchester. It specializes in rapid molecular diagnostic tests for life- threatening fungal infections. Traditional methods for detecting fungal infections are well-documented as being relatively insensitive and slow, Mullis notes. In fact, he states that 50 percent of aspergillosis cases are diagnosed on the mortuary table.
Tests provided by Myconostica aim to allow healthcare professionals to rapidly identify patients infected and enable clinicians to prescribe appropriate drug therapy via a portfolio of real-time PCR molecular diagnostic tests for life-threatening fungal infections. As many as 10 million to 12 million people are at risk for these infections each year in Europe and North America alone, Mullis says. Among the worst, Aspergillosis affects leukemia, transplant and corticosteroid-treated patients, including asthma and COPD. Pneumocystis affects HIV-infected and AIDS patients as well as many others with sub-optimal immune symptoms.
Myconostica has three CE-marked products on the market in Europe, Canada and Southern Africa, which were launched in 2010 and are capable of running on a wide range of testing platforms. These include a product for extracting fungal DNA from human samples and tests for the detection of Aspergillus and Pneumocystis jirovecii. Lab21 will seek U.S. Food and Drug Administration approvals upon review.
Mullis also says that commercial discussions with prospective U.S.-based customers are underway, along with plans to seek support on the distribution side.
The privately held company provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. The products division manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. In addition to its corporate offices in Cambridge and South Carolina, the company has a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley and Bridport, U.K.
Speaking about the transaction, Prof. David Denning of the University Hospital of South Manchester, founder and chief medical officer of Myconostica, says, "We have developed fast and sensitive molecular diagnostics for life-threatening fungal infections such as Aspergillosis and Pneumocystis pneumonia that will transform patient care for these infections. Fungal infections are frequently under-diagnosed using current diagnostic methods and are much more common than realized. The global reach of Lab21's operations will extend the availability of Myconostica's products to many more clinicians. I look forward to working with Lab21 to further develop the evidence base demonstrating the great clinical value of molecular testing for fungi, as is routine for viruses."

Lab21 focuses on diagnostic tests with Microgen Bioproducts acquisition
CAMBRIDGE, U.K.—Lab21 Ltd. last month also announced the acquisition of Microgen Bioproducts Ltd., a U.K.-based company specializing in the development, manufacture and sale of diagnostic tests to identify diseases and organisms that pose a threat to health.
Financial terms of the acquisition were not disclosed. Lab21 said Microgen's expertise in microbiological assay development and commercialization complements its diagnostics portfolio, particularly in the infectious disease market, and provides further expansion of its distribution channel in key territories such as the United States, United Kingdom, Europe and Asia.
"Microgen Bioproducts is a well-established and profitable business which will significantly contribute to our growth plans in our core products division," said Graham Mullis, CEO of Lab21, in a statement. "This acquisition highlights Lab21's commitment to continuing its exciting roll-up strategy and we expect to bring other high-quality acquisitions into the group during 2011."
Code: E071113



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