The National Strategy for Pandemic Influenza Implementation Plan (2006) (PDF - 404 MB) called for HHS to develop and deploy diagnostics with greater sensitivity, speed and reproducibility to afford detection of pandemic influenza viruses in near-patient (point-of-care) settings. Rapid, accurate diagnostic tests can facilitate early warning, outbreak control and targeted antiviral drug therapy for infected patients. During seasonal epidemics, rapid and accurate diagnostic tests for influenza viruses allow healthcare providers to initiate earlier antiviral therapy, limit additional diagnostic testing, and potentially reduce antibiotic use. Rapid, accurate tests that enable early recognition of a novel influenza virus can guide clinical/public health interventions and help monitor the spread of influenza within communities. BARDA's Influenza Diagnostics Program's goal are to build preparedness for pandemic influenza with fast, simple and accurate influenza diagnostic tests that also support rapid treatment and control of seasonal influenza in community settings, and to provide more and better information on antiviral drug usage.
BARDA's Influenza Diagnostics Program (in partnership with CDC's Influenza Division) has supported a number of successful projects since 2007. One major accomplishment made possible with BARDA support was the development of the 3M/Focus diagnostic product, Aura®, that rapidly detects influenza A, B, and Respiratory Syncytial Virus. Aura® received FDA-clearance in 2012 and had been adopted into clinical diagnostic practice. BARDA support also led to four (4) new rapid influenza tests that were CLIA-waived from 2011-2013 and can now be used simply and accurately to diagnose viral infection at or near the site of patient care. Emergency Use Authorizationss were issued for two (2) BARDA-funded diagnostic products to detect H1N1 influenza virus during the 2009 H1N1 pandemic. Three (3) of these products subsequently were FDA-cleared, providing increased diagnostic capability in clinical labs. BARDA also increased domestic influenza diagnostic capacity by supporting the development of an investigational product that facilitated recognition of the first pandemic H1N1 2009 case in the U.S., and the upgrading of public health labs with instrumentation needed for high throughput diagnostic testing at the onset of the 2009 pandemic.
BARDA currently supports advanced development of three (3) product candidates to improve influenza diagnostic capability and capacity: an antiviral resistance test by Becton Dickinson, a genotyping microarray by InDevR Inc., and a low-cost, rapid test by Alere, Inc. BARDA also is supporting a Johns Hopkins University study to demonstrate the implementation of rapid diagnostic test systems with best practice advisories (electronic prompts) in emergency departments and the impact of these systems on antiviral drug usage. Preliminary results from the JHU study show that having rapid diagnostics available increased influenza antiviral drug prescriptions by more two-and-a-half (2.5) fold. Further studies may provide additional evidence to promote clinical- and cost-effectiveness, in support of an ultimate goal to improve antiviral drug use and health outcomes.
Future BARDA work will focus on developing capability to recognize potential pandemic influenza viruses in point-of-care settings, speeding influenza diagnosis to prompt early antiviral use and addressing restrictive outpatient reimbursement by healthcare providers. BARDA also plans to support advanced development of new nucleotide sequencing technologies and prodromal or pre-symptomatic biomarkers for influenza. By continuing to widen availability of enhanced influenza diagnostic tools, BARDA will promote effective, timely management and treatment of seasonal and pandemic influenza, and reduce impact on health, communities, and the Nation.