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EraGen Said to Develop SARS Diagnostic; Solicits Validation

EraGen Biosciences has used its Gene-Code technology to develop a diagnostic for severe acute respiratory syndrome, and has begun shipping the test to the World Health Organization and the British Columbia Center for Disease Control, the company said last week.

EraGen is also developing a genotyping assay to differentiate the SARS strains sequenced to date.

EraGen will initially offer the SARS test to reference labs, the Centers for Disease Control and Prevention, and “other governmental agencies willing to validate the test,” it said.

EraGen’s SARS-specific assay test was developed after the genome of the coronavirus that causes the disease was sequenced by researchers. “Because our tests analyze the basic genetic structure of pathogens, they are … more accurate in the early detection of the disease than tests which examine the body’s immunological response,” said Irene Hrusovsky, CEO of EraGen.

EraGen, which develops and provides products for the diagnostics and pharmaceutical industries, said the technology used in the test is able to detect and differentiate pathogens in less than 60 minutes.

To be sure, the effectiveness of EraGen’s SARS test has not been determined. Health officials trying to control the disease, which is confirmed to be a coronavirus, have been slowed by a lack of a reliable diagnostic test.

SARS has infected at least 5,400 people and killed at least 373, with cases in more than 20 countries.

EraGen is the latest in a growing contingent of companies and government agencies angling to develop and patent diagnostic tests or components. To that extent, the company is hoping that independent labs will verify that its test works within a week, which could make it the first to market. Earlier this week, for example, Focus Technologies said it had developed a first-generation real-time PCR test to detect the presence of the SARS-causing virus, and Affymetrix began selling a GeneChip that will enable scientists to resequence different isolates of the virus.

That test relies on RT-PCR to identify RNA from the virus. The assay is based on work by the World Health Organization and the Bernhard-Nocht Institute in Hamburg, Germany, to identify PCR primers for the virus.

Earlier this month, Roche Diagnostics said it plans to launch a diagnostic test for the coronavirus by the end of July. The test, to be developed by mid-June, will be based on Roche’s real-time PCR technology and will run on the firm’s LightCycler PCR system.

“Getting first to market is obviously great, but what we really want to be is best to market,” Hrusovsky was reported to have told the Capital Times of Madison.

— KL


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