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GEN News Highlights : May 23, 2011

Lab21 Takes Over Myconostica to Expand Portfolio of Diagnostics for Fungal Infections

New business is expected to diversify offerings, provide first nucleic acid-based assays, and add manufacturing capacity.

Lab21 has acquired U.K. firm Myconostica, a University of Manchester spin-out focused on developing molecular diagnostics for life-threatening invasive fungal infections. Lab21 says the acquisition will expand its own infectious disease diagnostics portfolio, provide its first set of nucleic acid-based assays, and add new manufacturing capabilities for the development and production of a range of biomarker assays.

Myconostica already has three CE-marked assays, which were launched in Europe, Canada, and South Africa in 2010, and are approved to run on a range of testing platforms. The MycAssay™ Aspergillus kit is a real-time PCR assay for the detection of Aspergillus DNA in lower respiratory tract samples and serum samples. In April the firm reported research data demonstrating that the test could directly detect azole resistance in aspergillosis patients without the requirement for culturing the fungus on agar.

MycAssay Pneumocystis is a molecular-based assay for detecting the common respiratory fungal pathogen Pneumocystis jirovecii in human clinical respiratory specimens. Also in April, Myconostica reported publication of positive data from a multicenter prospective trial evaluating this PCR-based assay in comparison with non-molecular methods.  

Myconostica’s complementary MycXtra® kit is designed to extract and purify fungal DNA from clinical bronchoalveolar lavage (BAL) and other respiratory samples, and in addition remove PCR inhibitors such as heparin and tobramycin. The firm claims that using MycXtra in combination with its MycAssay tests allows laboratories to generate fungal testing results within three hours.  

The firm has in addition developed a research-use assay, MycArray™ Yeast ID, for identifying and speciating yeasts from extracted DNA samples or directly using colony PCR. The kit is designed to simultaneously detect up to 17 yeast species, can identify mixed infections, and works directly from a colony PCR or extracted DNA, generating results in about four hours.

Also based in the U.K., Lab21 provides molecular diagnostic products and services in personalized medicine to healthcare organizations, clinical laboratories, and pharmaceutical companies. The firm’s clinical laboratory services operation offers specialized personalized medicine diagnostic testing services for applications in pharma development (companion diagnostics) and clinical diagnostics, including cancer mutation testing and infectious disease tests. Its diagnostic products division is focused on infectious disease testing kits for the blood banking and clinical markets. Lab 21’s U.S. subsidiary operates a CLIA laboratory for the provision of diagnostic services including personalized medicine tests for oncology and virology applications. The U.S. facility will in addition offer clinical trials support.

In January Lab21 acquired diagnostics firm Microgen Bioproducts, which develops and manufactures diagnostic products for the clinical, food, industrial veterinary, and environmental testing markets.