Immunetics Introduces New Clinical Laboratory Services for Diagnosis of Invasive Fungal Infections

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Immunetics Introduces New Clinical Laboratory Services for Diagnosis of Invasive Fungal Infections

BOSTON--(Business Wire)--Immunetics, Inc., 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 in the US. MycoDx™ is a multiplex molecular assay developed by Immunetics 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.

"Invasive fungal infections are a growing concern not only for patient outcomes but also for the economic burden they present. One invasive fungal infection in a transplant patient can increase length of hospital stay by up to 19 days and cause $55,400 in additional costs," said John Yonkin, CEO of Immunetics.

Globally, the incidence of invasive fungal infections is more than 2 million per year, with mortality rates that can exceed 50%. Several factors contribute to the high mortality rate: first, human disease is caused by a diverse range of fungal pathogens; second, most current assay technologies only detect a few of the more common species and can miss the vast majority of fungal pathogens; and lastly, these technologies can take several days to a week to provide results. This problem is exacerbated by the growing numbers of patients at risk, including transplant patients and those undergoing immunosuppressive therapy or immunocompromised due to HIV infection. The need for improved diagnostic tools to quickly identify invasive fungal infections is recognized worldwide.

"The National Institutes of Health supported the research and development of this assay through a $3.6 million SBIR grant to Immunetics, another example of a transformational technology developed by Immunetics with NIH support. We believe that the breadth of fungal pathogens covered by our assay is unprecedented in the field," said Andrew Levin, Immunetics' Founder and Chief Scientific Officer.

The MycoDx Assay available through Immunetics' clinical reference laboratory will provide:

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 directly from whole blood patient samples – no blood cultures required. Additional sample types are currently under development.

Rapid assay turnaround time - 8 hours for all 21 targets (most current methods can take 48-72 hours or more).
Immunetics has an established record for development of unique diagnostic tests and products to solve complex problems in infectious disease, such as the FDA cleared BacTx® rapid test for bacterial contamination in platelets. "Through our expansion in the clinical laboratory reference services area, Immunetics is now making available to the US marketplace a novel molecular test that will accurately identify invasive fungal infections in a timely manner, with more targets in development," said Yonkin. "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."

For more information about clinical laboratory reference services and the MycoDx Invasive Fungal Infection Assay, visit the Immunetics website at www.immunetics.com or contact the company at 1-617-896-9100 or toll-free at 1-800-227-4765.

About Immunetics

Immunetics, Inc. offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. Immunetics is headquartered in Boston. The company's mission is to deliver better, cost-efficient care through more accurate diagnosis. For more information, visit the Immunetics website at www.immunetics.com.

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Immunetics, Inc.
Ed Keohan, 1-800-227-4765
ekeohan@immunetics.com