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Pathonostics Gets CE Mark for Next-Gen Test for Fungal Skin Infections

NEW YORK – Dutch molecular diagnostics firm Pathonostics announced on Monday that it has obtained the CE mark for a next-generation version of its multiplex PCR-based dermatology test.

Called the DermaGenius 3.0 Complete Multiplex real-time PCR kit, the test can assist in the diagnosis of dermatophytosis, a fungal infection of the skin, which typically results in itchy, red, scaly, circular rashes.

The Pathonostics test can detect up to 95 percent of clinically relevant dermatophytes, the firm said in a statement. The test has a turnaround time of less than three hours and can be used in combination with the Pathonostics Extraction kit, which is designed for the extraction of hair, nail, and skin samples.

Using microscopy for fungal skin infection diagnosis lacks specificity, according to the Maastricht, Netherlands-based company's website, while fungal culturing has a turnaround time of two to four weeks and is prone to contamination.

DermaGenius 3.0 expands on an already available test by adding targets for Scopulariopsis brevicaulis, Candida parapsilosis, and Nannizia gypsea.

The original 14 targets of the 2.0 assay are: Candida albicans, Trichophyton mentagrophytes, T. interdigitale, T. rubrum/soudanense, T. tonsurans, T. violaceum, Microsporum canis, M. audouinii, Epidermophyton floccosum, T. benhamiae, T. verrucosum, a pan-dermatophyte target, and an internal control.

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