FDA Approves First Blood Test for Anthrax
Boston Based Company Test Shown to be Accurate for Anthrax Diagnosis
Immunetics, Inc. announced the approval today by the Food and Drug Administration 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. Test results will be used together with other clinical evidence by physicians and healthcare workers to diagnose anthrax in suspected cases. 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.
“The release of this test represents a significant achievement for Immunetics” said Dr. Andrew Levin, the company’s founder and Chief Executive Officer. “After the October 2001 attacks occurred, CDC sought the help of commercial partners to solve a critical problem. We believed that our technology and track record in rapid development of diagnostic tests would be useful. Given the events, our obligation as a company was to act in the nation’s service in whatever way was needed. We were honored to win the contract and to work collaboratively with CDC on the development of the anthrax test. The fact that we were able to move so quickly in development and validation of the test demonstrates how productive such a collaboration between government and industry can be, and we consider the FDA approval a major success for both sides.”
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. The Company produces and markets a range of infectious disease immunoassay kits and instruments.