Medical Device Link.

Originally Published IVD Technology June 2004

INDUSTRY NEWS

Even though the government does not fully recognize the important role of diagnostics as a part of biodefense efforts, some biodefense diagnostics have been developed such as the handheld advanced nucleic acid analyzer (HANAA) by Lawrence Livermore National Laboratory (Livermore, CA).

President Bush recently approved a directive that provides a framework for the nation’s biodefense program. While the directive does cover various medical and public health issues, it fails to recognize the critical role of diagnostics as a part of biodefense efforts.

“The directive falls short regarding the need to develop biodefense diagnostics,” says Rick Naples, chairman of the Medical Technology Preparedness Council’s work group on technology development and regulation at AdvaMed (Washington, DC). “Though the directive emphasizes the need for medical response measures such as antibiotics and vaccines, diagnostic tests are not mentioned.” 

Industry groups such as AdvaMed are not surprised by this oversight, since previous biodefense programs have primarily focused on developing vaccines and therapeutics. Even though the importance of diagnostics in biodefense should not be overlooked, the federal government still does not fully recognize the important role that clinical IVDs will play in the event of a bioterrorist attack.

For example, the directive discusses the need to expand and improve biosurveillance and early warning systems, in which diagnostics are used. Diagnostic devices are components in the BioWatch program and in the U.S. Postal Service’s biohazard detection system. However, they are limited to passive environmental detection and are not applied for medical purposes. Although some of these detection technologies could be adapted for such medical diagnostic purposes, the government has made little effort to encourage developing and validating them for clinical IVD use. 

In addition, while the directive explains government activities to coordinate its biodefense efforts among the various agencies, it does not clearly address the involvement of private industry. Nonetheless, the directive does allude to two areas where an expanded role for IVD manufacturers in developing biodefense diagnostics could take place.

First, the directive mentions the planned expansion and integration of biosurveillance programs, such as the Centers for Disease Control and Prevention’s BioSense program. IVDs could play a key role in such syndrome surveillance systems. For example, an IVD test for influenza could rapidly identify areas where the flu has become epidemic, which would allow targeted and efficient distribution of effective pharmaceuticals. 

Second, the directive states that biodefense measures are expected to augment and complement methods developed to protect against emerging infectious diseases. The IVD industry has a proven track record in this area. The core competencies that enabled IVD manufacturers to develop tests for HIV, West Nile Virus, and SARS can be used to develop novel tests for emerging bioterrorism pathogens.

The government has set up programs that support and offer funding for biodefense research. For example, in July 2003, the National Institute for Allergy and Infectious Disease (NIAID;) announced two initiatives to develop new drugs, diagnostics, and vaccines related to biodefense. Through such initiatives, NIAID has been offering grants in order to address research and development priorities in these areas and emphasize product development and cooperative enterprises with private industry. 

However, according to AdvaMed, the majority of biodefense funding continues to go to developing vaccines and therapeutics. In 2004, Project BioShield spent over $1 billion on vaccines and therapeutics and more than $64 million on diagnostics. In 2003, NIAID sponsored a small business biodefense program for developing therapeutics, vaccines, and diagnostics in which only 15% of the grants were awarded to diagnostics. 

“While we certainly hope the government will continue to expand funding for biodefense diagnostics, it is unclear at this point whether funding for current and planned programs will continue at expected levels or be redirected under the current biodefense initiative,” says Naples.

For more information about NIAID’s biodefense grants, please visit the NIAID Web site at www.niaid.nih.gov. 

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