Lab21 targets fungal infections

CAMBRIDGE, U.K.—Lab21 Ltd., a personalized medicine andclinical diagnostics company, has made its sixth acquisition in the past twoyears with the purchase of Myconostica Ltd., a molecular diagnostic companyfocusing on the diagnosis of clinically significant fungal infections. Thefinancial terms of the deal were not disclosed.

The acquisition of Myconostica expands Lab21's growingproprietary diagnostic portfolio and will provide the company's first set ofnucleic acid-based assays. It also provides manufacturing capabilities forLab21 from which it plans to further develop and produce its range of newbiomarker assays.

In addition to developing global sales of Myconosticaproducts, Lab21 will also be launching the Myconostica fungal testing servicesfrom its new reference laboratory in South Carolina as well as its laboratoryin Cambridge.

Current fungal diagnostic tests based on culturingtechniques have significant clinical limitations, and Myconostica says itsmolecular diagnostic approach provides more rapid, sensitive and specificinformation, which together will improve clinical outcomes.

"Lab21's growth strategy is based on the classicalacquisition model," says Graham Mullis, Lab21's CEO. "Myconostica has been onour list for two years or more, and we are delighted they are now on board. Thecompany's products complement our infectious diseases portfolio and helpposition the company in a large market where there are significant clinicalchallenges."

Mullis notes that his company's newest acquisition will soonannounce two new products and has a facility in South Carolina—nowunmanned—that is available as needed for growth.

Myconostica, also based in the United Kingdom, was spun outfrom the University of Manchester. It specializes in rapid molecular diagnostictests for life-threatening fungal infections. Traditional methods for detectingfungal infections are well-documented as being relatively insensitive and slow,Mullis notes. In fact, he states that 50 percent of aspergillosis cases arediagnosed on the mortuary table.

Tests provided by Myconostica aim to allow healthcareprofessionals to rapidly identify patients infected and enable clinicians toprescribe appropriate drug therapy via a portfolio of real-time PCR moleculardiagnostic tests for life-threatening fungal infections. As many as 10 millionto 12 million people are at risk for these infections each year in Europe andNorth America alone, Mullis says. Among the worst, Aspergillosis affects leukemia, transplant and corticosteroid-treatedpatients, including asthma and COPD. Pneumocystis affects HIV-infected and AIDSpatients as well as many others with sub-optimal immune symptoms.

Myconostica has three CE-marked products on the market inEurope, Canada and Southern Africa, which were launched in 2010 and are capableof running on a wide range of testing platforms. These include a product forextracting fungal DNA from human samples and tests for the detection of Aspergillus and Pneumocystis jirovecii. Lab21 will seek U.S. Food and Drug Administrationapprovals upon review.

Mullis also says that commercial discussions withprospective U.S.-based customers are underway, along with plans to seek supporton the distribution side.

The privately held company provides diagnostic products andservices and supports blood bank screening, medical diagnostics and drugdiscovery. The products division manufactures immunodiagnostic kits andreagents that are distributed internationally and is focused on infectiousdiseases for the blood-banking and clinical markets. In addition to itscorporate offices in Cambridge and South Carolina, the company has a GMPmanufacturing site in Cambridge and other manufacturing facilities inNewmarket, Camberley and Bridport, U.K.

Speaking about the transaction, Prof. David Denning of theUniversity Hospital of South Manchester, founder and chief medical officerof Myconostica, says, "We have developed fast and sensitive moleculardiagnostics for life-threatening fungal infections such as Aspergillosis and Pneumocystis pneumonia that will transform patient care for theseinfections. Fungal infections are frequently under-diagnosed using currentdiagnostic methods and are much more common than realized. The global reach ofLab21's operations will extend the availability of Myconostica's products tomany more clinicians. I look forward to working with Lab21 to further developthe evidence base demonstrating the great clinical value of molecular testingfor fungi, as is routine for viruses."

Lab21 focuses on diagnostic tests with MicrogenBioproducts acquisition

CAMBRIDGE, U.K.—Lab21 Ltd. last month also announced theacquisition of Microgen Bioproducts Ltd., a U.K.-based company specializing inthe development, manufacture and sale of diagnostic tests to identify diseasesand organisms that pose a threat to health.

Financial terms of the acquisition were not disclosed. Lab21said Microgen's expertise in microbiological assay development andcommercialization complements its diagnostics portfolio, particularly in theinfectious disease market, and provides further expansion of its distributionchannel in key territories such as the United States, United Kingdom, Europeand Asia.

"Microgen Bioproducts is a well-established and profitablebusiness which will significantly contribute to our growth plans in our coreproducts division," said Graham Mullis, CEO of Lab21, in a statement. "Thisacquisition highlights Lab21's commitment to continuing its exciting roll-upstrategy and we expect to bring other high-quality acquisitions into the groupduring 2011.