Abbott Laboratories, a global, broad-based health care company, announced a worldwide marketing and distribution agreement with Artus GmbH, a German-based biotechnology company, for the first commercial test to detect a form of the coronavirus suspected of causing Severe Acute Respiratory Syndrome (SARS).
Developed by Artus in collaboration with the Bernhard-Nocht-Institute for Tropical Medicine (BNI) in Hamburg, Germany, the test was introduced by Artus in April to countries in Asia and Europe and has been provided to laboratories under the direction of the World Health Organization (WHO) and other major clinical sites conducting studies on the SARS virus. Initial results of different sample types (sputum, swabs, stool and tissue) from these WHO laboratories are promising.
The test is based on a highly sensitive technology known as polymerase chain reaction (PCR), which directly detects the virus in patient samples, and produces results in two hours.
"We now believe SARS is caused by a new form of the coronavirus, a relative of one of the many viruses that cause the common cold," said James Koziarz, Ph.D., vice president, diagnostic products research and development, Abbott Laboratories. "We believe this new test is sensitive enough to detect the virus in the early stages of infection."
Under the agreement, Artus will manufacture the test and, after appropriate regulatory approvals, Abbott will market and distribute it initially for use on the Roche LightCycler thermal cycler system in the U.S., Canada, Germany, the U.K. and Austria, supplementing Artus' existing distribution agreements. Within several weeks, the test will also be available on the Applied Biosystems ABI Prism 7000 Sequence Detection System for worldwide distribution. Abbott will assist Artus in submitting this test to the U.S. Food and Drug Administration as quickly as possible.
"Because of Artus' long-time experience with coronaviruses, we were able to develop the SARS test very quickly," said Michael Tillmann, managing director, Artus. "Through Abbott's strong distribution channels this important test can be made widely available to health care professionals and patients who urgently need it."
Abbott will market and distribute the test through its molecular diagnostics alliance with Celera Diagnostics. That alliance, established in June 2002, is focused on developing and marketing a broad menu of next-generation molecular diagnostic products for unmet diagnostic needs. Celera Diagnostics, headquartered in Alameda, Calif., is a joint venture between two Applera Corporation businesses, Applied Biosystems and Celera Genomics.
SARS is a respiratory illness that has recently been reported in Asia, North America, and Europe. In mid April, the Centers for Disease Control and Prevention (CDC) announced that the genome for the coronavirus believed to be responsible for the global epidemic of SARS had been sequenced. According to the CDC, the illness usually begins with a fever, which is sometimes associated with chills or other symptoms, including headache, cough, general feeling of discomfort and body aches. The primary way that SARS appears to spread is by close person-to-person contact.