InDevR Wins BARDA Contract for Cutting-Edge Influenza Diagnostic
News Sep 17, 2014
InDevR has announced that it has signed a contract (HHSO100201400010C) with the Biomedical Advanced Research and Development Authority (BARDA) to complete product development of their unique influenza diagnostic, FluChip-8G, which is capable of rapidly genotyping influenza viruses directly from clinical samples. The total contract award is for up to $14.7 M, contingent upon successful completion of project milestones.
"The FluChip-8G system will provide an unprecedented level of information about viruses detected in human clinical specimens, without the need for virus isolation. This information will allow physicians to make better informed decisions about treatment options for their patients," said Dr. Kathy Rowlen, InDevR's CEO.
Once cleared by the U.S. Food and Drug Administration, FluChip-8G will enhance clinical diagnosis of influenza in hospitals, urgent care facilities, and clinical laboratories by enabling physicians to rapidly distinguish between seasonal strains and potential pandemic non-seasonal strains of the influenza virus, such as H5N1 or H7N9.
According to Dr. Aleta Bonner, Clinical Researcher and Pediatric Emergency Physician, "The potential for the FluChip-8G platform to provide both FDA-cleared results of clinical significance as well as epidemiologically-relevant results is a significant advance over currently available platforms. Influenza surveillance activities and antiviral resistance monitoring have traditionally been viewed as primarily academic and/or public health concerns. The potential for emergence and circulation of new pandemic strains as well as continued threats of bioterrorism attacks increases the need for all medical providers to have some knowledge of influenza surveillance and antiviral resistance trends. The ability of the assay to provide rapid turnaround of the patient's clinical result combined with surveillance and antiviral resistance information through delivery of real-time data makes this an incredibly robust platform. Such a platform would improve clinical decision-making and patient care while providing the ability to rapidly aggregate community level data to track antiviral resistance and other trends on a national or even international level."
The contract for advanced development is supported by BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. Consistent with ASPR's mission, this contract supports the development of a new method for identifying emerging and potentially pandemic influenza viruses.
Rowlen commented, "InDevR is thrilled about the partnership with BARDA. Their support will enable us to complete the final stages of product development and conduct clinical studies for a 510(k) submission to the FDA. If all goes well, we will launch the first commercial version of FluChip-8G in 2016."
In a small study of patients referred to the Johns Hopkins Early Psychosis Intervention Clinic (EPIC), researchers report that about half the people referred to the clinic with a schizophrenia diagnosis didn’t actually have schizophrenia. People who reported hearing voices or having anxiety were the ones more likely to be misdiagnosed.