FDA Approves First Blood Test for Anthrax

Immunetics, Inc. have announced the approval FDA of its test for anthrax infection. The approval represents a significant step forward in the public health community’s ability to diagnose anthrax.

The Immunetics test is the first for anthrax approved by the FDA for direct use on patient blood specimens. Unlike many of the procedures previously available only in a small number of government laboratories, the new test can be used by any clinical or public health laboratory without the need for specialized equipment or training.

The test was shown to detect 100% of the anthrax patients tested in clinical trials, with less than a 1% chance of false positive results. The test operates by detection of antibodies to a key component of the anthrax bacillus, which forms part of the toxin responsible for its deadly effects.

Test results were shown to be positive for individuals with either inhalational or cutaneous anthrax, both of which were contracted by patients in the October 2001 attacks. In addition, the test detects anthrax-specific antibodies in a variety of animals which have been used as models for human infection.

The test was developed by Immunetics, Inc., a Boston, Massachusetts based diagnostics and assay technology company, under a contract awarded by the Centers for Disease Control and Prevention (CDC) following the October 2001 anthrax attacks in the United States. The CDC selected Immunetics to develop a standardized test kit which could be made widely available in the event of another suspected bioterrorism attack. Immunetics worked closely with CDC scientists in developing the test, which is based on the company’s proprietary assay technology.

Immunetics offers state-of-the-art assay technology for infectious disease research and diagnosis, and for over 10 years has been a leading innovator of tests for some of the world’s most serious diseases.