Originally Published IVD Technology January 2006
INDUSTRY NEWS
Bird flu pandemic fears fuel diagnostic development
The Bush administration’s plan to prepare for a possible avian influenza pandemic includes policies to “develop and deploy rapid diagnostics with greater sensitivity and reproducibility to allow on-site diagnosis of pandemic strains of influenza.” Taking this cue, government agencies and several IVD companies have initiated and are undertaking a number of efforts to address this issue.
The inclusion of diagnostic tools development in the administration’s pandemic influenza strategy stems from the fact that the antigen detection tests being used for bird flu are insufficient and unreliable. According to documents released by the Department of Health and Human Services (HHS), “The influenza diagnostic tests that are currently available have limited sensitivity and specificity and are not able to discriminate between viral subtypes.”
The National Institute of Allergy and Infectious Diseases (NIAID; Bethesda, MD), a part of the National Institutes of Health (NIH), has been designated as one of the lead government agencies involved in efforts to develop diagnostic tests for avian influenza. NIAID’s primary challenge is developing IVDs that can provide accurate results in a timely fashion.
“The current IVDs for avian flu do work rapidly and can generate results within 30 minutes, but they exhibit a high rate of false-positives and false-negatives because they have difficulty distinguishing among the commonly circulating flu strains,” says David Cho, PhD, an influenza program officer at NIAID. “At the same time, while growing samples collected from infected patients in cell cultures is the gold standard, it takes about a week before a detectable amount of virus emerges.”
To address this dilemma, NIAID has been supporting research examining a number of different diagnostic techniques. For example, such research involves microarrays, microfluidic devices, and other immunoassays that use novel optical detection systems. In particular, NIAID has been focusing on employing molecular diagnostic technologies to develop genetic tests for avian influenza.
“Right now, the flu tests that are out there detect an antigen or enzymes, and are looking only at protein levels,” says Cho. “Since technologies have evolved during the last several years where we can look more specifically at the DNA level, we’re trying to develop tests that can look at that level and distinguish among the flu subtypes.”
During the past couple of years, NIAID has awarded grants to several researchers to develop new diagnostics to discriminate between several pathogens including avian influenza. One of those researchers, Steven E. Kornguth, PhD, the director of the Center for Strategic and Innovative Technologies at the University of Texas– Austin, has been working on a diagnostic platform that can detect genomic sequences of bacterial and viral pathogens.
“Our plan has been to make a very universal kind of genomic rapid detection system that could be used for either virus or bacteria,” says Kornguth. “It’s not looking for antibodies, but rather genetic materials, so it should be able to be used for any threat agent, including avian flu.”
Since President Bush announced the pandemic influenza plan, several IVD companies have announced the availability of various diagnostic products that can be used to test for avian flu. CombiMatrix (Mukilteo, WA) launched a comprehensive influenza DNA microarray that can detect and type flu strains, including bird flu. Tm Bioscience Corp. (Toronto) developed an upper respiratory viral panel that detects all of the major human respiratory viruses, including avian flu. Tm Bioscience is in discussions with FDA on preparing a submission for expedited review.
Other IVD companies include Remel Inc. (Lenexa, KS), which confirmed that its Xpect flu A&B test can detect avian flu. Remel submitted analytical study results to FDA that were cleared for incorporation into the analytical sensitivity section of the test’s package insert. Genaco Biomedical Products (Huntsville, AL) announced that its Templex molecular diagnostic test can detect all known avian flu strains.
Additional information can be accessed via the NIAID Web site at www3.niaid.nih.gov.
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