Myconostica, a Manchester, UK-based medical diagnostic firm that sells assays for fungal infections, is planning to expand its menu of array-based pathogen-detection kits in two years, according to a company official.
Chief Business Officer John Thornback told BioArray News this week that the company will debut a MycArray Mold ID array by the beginning of 2012 that will enable users to identify different species of microscopic fungi.
The launch will follow the 2009 release of Myconostica's 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 tests are for research use only.
The 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.
"We intend to have a series of real-time PCR tests and a series of microarray tests," Thornback said. In addition to mold, he said "there are other areas of fungal disease that could lend themselves to arrays." Myconostica is also considering adding drug-resistance markers to MycArray Yeast ID, he said.
Founded in 2007 as a spinout of the University of Manchester, Myconostica currently sells a number of RT-PCR-based tests other than MycArray Yeast ID.
"We are a sector diagnostics company, developing diagnostics for invasive fungal infections," said Thornback. "We use whatever technology suits the clinical question we are trying to answer."
The company currently sells two RT-PCR tests for use in clinical labs. Its MycAssay Pneumocystis kit is designed to detect Pneumocystis jirovecii in respiratory samples. The test, used to diagnose Pneumocystis pneumonia, is CE marked in the EU and Health Canada has approved it for clinical use with most RT-PCR thermal cyclers on the market. 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.
While the MycAssays represent Myconostica's presence in the molecular diagnostics market, MycArray Yeast ID is currently sold to specialist research microbiology labs through distributors in Europe and in Canada. Though it sells the kit in the US, Thornback said that Myconostica is currently seeking an American distributor.
"We have pushed Yeast ID out to the reference laboratories, rather than the routine diagnostics labs," said Thornback.
He said that the regulatory route for future MycArrays will depend on the needs of customers, and that the firm is discussing whether it will seek a CE mark for MycArray Yeast ID.
"Some of the arrays will be [for] research and some will be CE marked," said Thornback. "It depends on what customers want," he added. "Do they need a CE-marked product? If they do, then we'll go down that route."
According to Thornback, there is "real demand in routine clinical labs for better fungal diagnostics." While RT-PCR can determine the presence of a pathogen, and arrays can provide users with the species of the fungi that is present, Thornback said that Myconostica is considering developing assays that assess drug resistance to guide treatment.
"That is the decision tree of fighting fungal disease," he said.