Medical Device Link.

Originally Published IVDT September 2002

INDUSTRY NEWS

Richard Park

A set of government guidelines regarding anthrax testing has already started to stir up controversy within the IVD industry.

In July, the General Services Administration (GSA; Washington, DC) issued a policy advisory with guidelines that outline standard operating procedures for managing potential anthrax contamination in federal mail centers located in the Washington, DC, metropolitan area. An interagency working group comprising several federal agencies—including the Federal Bureau of Investigation (FBI; Washington, DC), the Centers for Disease Control and Prevention (CDC; Atlanta), and the Office of Homeland Security (Washington, DC)—developed the guidelines.

One section of the guidelines covers recommendations regarding anthrax detection equipment and routine sampling. The recommendations concluded that microbiological culture in a CDC-approved laboratory is the gold standard for anthrax testing, while handheld immunoassays and polymerase chain reaction (PCR) methods should not be used for such testing.

Government officials claimed the guidelines were based on a thorough investigation of biodefense products that IVD companies had submitted.

"The FBI and CDC collaboratively did a study that looked at the commercially available handheld assays," says a senior White House administration official who spoke on condition of anonymity. "What they found was that there was an unacceptably high number of false positives and there were sensitivity issues. It really is disturbing when a kit can only detect 100,000,000 spores, which is 1000 times the lethal infectious dose. So it's just an inherent problem and a limitation of the assays themselves."

Some industry watchers believe that the guidelines are flawed and that the government has done a severe injustice to industry.

"The recommendations are a kick in the solar plexus to the IVD manufacturers that worked so hard last fall to help deal with the anthrax attacks," says Howard Coleman, chief executive officer at the Homeland Defense Technology Council (Washington, DC). "The process by which these guidelines were put together and released was irresponsible, unscientific, and exclusionary. The government didn't involve the people who use or make these devices in the decision-making process and have not yet released the data upon which these recommendations were based."

However, others believe that the government is not completely at fault and that industry should learn from the guidelines.

"In some cases, the industry itself abused the market," says Tom Gutshall, chairman of the board at Cepheid (Sunnyvale, CA). "Some companies went out and sold a device for an application for which it wasn’t appropriate. The bottom line is if everybody thought about it, they would realize that we should probably do more work on our protocols, think about sample collection procedures, and so on."

For more information about the guidelines, access GSA’s Web site at http://www.gsa.gov.

Copyright ©2002 IVD Technology