Clinical Laboratory Services Introduce Diagnosis of Invasive Fungal Infections

By LabMedica International staff writers
Posted on 08 Mar 2016

Globally, the incidence of invasive fungal infections is more than two million per year, with mortality rates that can exceed 50% and the need for improved diagnostic tools to quickly identify invasive fungal infections is recognized worldwide.

Several factors contribute to the high mortality rate including human disease is caused by a diverse range of fungal pathogens and most current assay technologies only detect a few of the more common species and can miss the vast majority of fungal pathogens and these technologies can take several days to a week to provide results.

Image: Photomicrograph of Cryptococcus neoformans using a light India ink staining preparation. Life-threatening infections caused by the encapsulated fungal pathogen Cryptococcus neoformans have been increasing steadily over the past 10 years because of the onset of AIDS, and the expanded use of immunosuppressive drugs (Photo courtesy of CDC/Dr. Leanor Haley).

Image: Histopathology of Cryptococcus neoformans in the lung of a patient with AIDS; the inner capsule of the organism stains red (Photo courtesy of Andrew Schott).

This problem is exacerbated by the growing numbers of patients at risk, including transplant patients and those undergoing immunosuppressive therapy or immunocompromised due to human immunodeficiency virus (HIV) infection. Immunetics, Inc. (Boston, MA, USA) a leading developer of clinical diagnostic assays, announced the launch of its new MycoDx assay for invasive fungal infections, which will be offered through its clinical reference laboratory service.

MycoDx is a multiplex molecular assay that can identify 21 fungal pathogens in a whole blood sample. Clinical samples can be tested directly with MycoDx, eliminating the prior culturing step required by many other assays. This capability reduces assay turnaround time, providing earlier results to clinicians to enable more effective treatment of life-threatening fungal infections. Such infections are particularly dangerous to immunocompromised patients including transplant recipients and those undergoing cancer therapies.

The assay results for a panel of 21 fungal targets including Candida, Aspergillus, Cryptococcus, Coccidioides, Fusarium and other species. Additional fungal targets are currently under development. Results are directly from whole blood patient samples as no blood cultures are required. Additional sample types are currently under development. There is a rapid assay turnaround time of 8 hours for all 21 targets, while most current methods can take 48 to 72 hours or more.

John Yonkin, CEO of Immunetics, said, “Our development team is currently working to transfer the assay into a user friendly microarray format for worldwide distribution. This will truly be transformational for the diagnosis of fungal disease, offering every hospital and reference laboratory access to unique technology to detect a broad range of fungal targets with same-day results.”

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Immunetics, Inc.