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Lab21 Gains Array-Based Pathogen-Detection Tests through Myconostica Buy


By Justin Petrone

Lab21, a Cambridge, UK-based medical diagnostics firm, this week acquired fungal disease test maker Myconostica for an undisclosed sum.

The acquisition gives Lab21 access to its first set of nucleic acid-based assays, including a growing menu of RT-PCR and microarray-based tests.

Lab21 CEO Graham Mullis told BioArray News this week that the company purchased Myconostica because its business is "complementary" to Lab21's infectious disease focus. Furthermore, the company provides Lab21 with a "strong proprietary position in fungal diagnostics, which is a diagnostic market with significant clinical restrictions."

Financial terms of the acquisition were not disclosed.

Manchester, UK-based Myconostica was founded in 2007 and currently offers a number of tests. Its RT-PCR-based MycAssay Pneumocystis kit is designed to detect Pneumocystis jirovecii in respiratory samples. It is CE marked in the EU and Health Canada has approved it for clinical use.

The company also offers MycAssay Aspergillus, a CE-marked, RT-PCR assay designed to detect Aspergillus in lower respiratory tract and serum samples. Aspergillus, a mold, causes a variety of illness categorized as aspergillosis.

On the array side, Myconostica in 2009 launched MycArray Yeast ID, which is designed to detect 18 species of pathogenic yeasts, including Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, and Cryptococcus neoformans, as well as the fungus Histoplasma capsulatum. The test is for research use only.

John Thornback, Myconostica's chief scientific officer, told BioArray News last September that the company planned to launch a new assay called MycArray Mold ID by the beginning of 2012 that would enable users to identify different species of microscopic fungi (BAN 9/28/2010).

Thornback did not return an e-mail this week seeking an update on the firm's plans.

Myconostica's arrays and readers are manufactured by Jena, Germany-based Clondiag, which is owned by Alere, formerly known as Inverness Medical Innovations. According to the firm, the assay takes four hours to obtain a result, including the PCR-based amplification step.

As of last September, MycArray Yeast ID was being sold to specialist research microbiology labs through distributors in Europe and in Canada. Though it sold the kit in the US, Thornback said at the time that Myconostica was seeking an American distributor. The deal with Lab21, which maintains a subsidiary in the US, could bolster international sales of Myconostica's products.

Indeed, David Denning, founder and chief medical officer of Myconostica, said in a statement that the "global reach of Lab21's operations will extend the availability of Myconostica's products to many more clinicians."

'Major Unmet Need'

Myconostica is the sixth firm Lab21 has acquired in the past two years. Most recently, the six-year-old company bought Microgen Bioproducts, a UK diagnostics company, in January for an undisclosed amount. In December 2009, Lab21 acquired Selah Technologies, a Greenville, SC-based nanotechnology company. Following the acquisition, Lab21 announced the formation of a US subsidiary called Lab 21 Inc. The subsidiary serves as both a North American diagnostics service laboratory and distribution operations center for the company.

This week, Lab21 said that it will soon begin offering Myconostica's tests from its facility in Cambridge as well as the Greenville laboratory.
"The integration of Myconostica will take place during the next few months and we will look to immediately commercialize the assays through our wide distribution channel as well as through our labs," Mullis said. He added that the company plans to begin offering the assays through the two labs by the end of the third quarter.

In a statement, Lab21 said that the Myconostica purchase will also provide the firm with manufacturing capabilities that it will use to "develop and produce its range of new biomarker assays."

The company said it acquired the company to meet a "major unmet market need for diagnosis of life threatening invasive fungal disease." It said that the company's technologies offer advantages over tests based on culturing techniques, which have "significant clinical limitations."

Mullis said in the statement that Myconostica's products complement Lab21's infectious diseases portfolio and "help position the company in a large market where there are significant clinical challenges."

The firm estimates that more than 10 million patients each year are at risk of developing life-threatening fungal infections and said that the global market for "fast and reliable invasive fungal infection diagnosis is substantial."

Have topics you'd like to see covered in BioArray News? Contact the editor at jpetrone [at] genomeweb [.] com.

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