EARLIER THIS MONTH, Focus Technologies reference laboratories of Cypress, California announced the development of a “first-generation, real-time PCR test” designed to detect the presence of the coronavirus associated with severe acute respiratory syndrome (SARS).
“Focus developed this test based on the methodology developed by the Bernhard-Nocht Institute of Hamburg, Germany,” stated Mary Kay Mosch, Vice President of Marketing at Focus. “Part of our corporate mission is to be a first provider, which is why we responded rapidly to the recognition of SARS as a new disease syndrome.
“There were challenges in validating our SARS test,” Mosch said. “Besides the usual difficulties in establishing clinically-relevant sensitivity and specificity, we had to insure there was no cross-reactivity with other types of coronavirus. We will continue to refine our RT-PCR assay and introduce additional SARS assays.”
Accessing SARS Specimens
“To further improve the test, we are working with contacts in the U.S., Europe, and Asia to obtain SARS specimens and other materials,” she added. “Additionally, as part of our SARS testing protocol, we also use methods developed by the Centers for Disease Control and Prevention (CDC).”
The SARS test offered by Focus Technologies is designed to complement testing done through public health laboratories. “It was reported that the CDC supplied reagents to more than 100 public health laboratories around the nation,” stated Mosch. “It published a clinical definition for suspected SARS patients. If a patient fits these criteria, which includes travel within the past ten days to a region where SARS is present, then testing for that patient can be done in a public health laboratory.”
Market For SARS Testing
The market for SARS testing in the U.S. remains limited. “So far, specimens referred to us come from physicians who suspect a patient may have SARS, but the clinical presentation didn’t necessarily meet the criteria defined by public health authorities,” explained Mosch. “Because of our 24-hour turnaround on the test, we can provide physicians with more timely information that may assist in the diagnosis of disease.”
Not surprisingly, Mosch states that, to date, all specimens for SARS testing referred to Focus Technologies have been negative. “If Focus does get a positive SARS specimen, the appropriate public health authorities will be immediately contacted.”
Even as Focus Technologies is first to publicize the availability of a SARS test in the United States, several other diagnostic companies are developing SARS assays to run on their instruments. Abbott Laboratories has a marketing agreement with Artus GmbH for its PCR-based SARS test. Following regulatory approvals, Abbott will market this test in the U.S. and other countries.