R-Biopharm Group Receives FDA Clearance for RIDASCREEN® Norovirus 3rd Generation EIA Antigen Detection Assay

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FDA permits marketing of first test for most common cause of gastroenteritis outbreaks. The test can aid in identifying and containing norovirus outbreaks.

R-Biopharm Group, Washington, MO, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its antigen detection assay, RIDASCREEN® Norovirus 3rd Generation EIA, as an aid in investigating the possible cause for acute gastroenteritis outbreaks.

Noroviruses are the most common cause of acute gastroenteritis world-wide, with more than an estimated 21 million cases a year in the US alone. They are frequently involved in outbreaks in community settings, such as nursing homes, hospitals, day care centers and prisons, and on cruise ships. Norovirus outbreaks are difficult to control and result in significant socio-economic burden. The RIDASCREEN® Norovirus 3rd Generation EIA assay facilitates the possible diagnosis of norovirus outbreaks in less than 2 hours, thereby enabling faster implementation of outbreak control procedures. R-Biopharm Group, a leading manufacturer of immunoassays for infectious disease now introduces this internationally successful test to the US clinical market. RIDASCREEN® Norovirus 3rd Generation is a qualitative enzyme immunoassay (EIA) intended for the detection of selected genogroup I and genogroup II norovirus strains in human feces. This represents the first FDA clearance for the in vitro diagnosis of norovirus infections. The test has not been cleared by FDA for diagnosing individual patients.

Lon Murphy, Vice President Clinical Sales R-Biopharm Inc., commented, “We are very excited to introduce this test to the US market. RIDASCREEN® Norovirus 3rd Generation EIA offers our laboratory customers a reliable, easy to use alternative to molecular testing. Rather than sending samples to a secondary facility, infections may be identified at or near the location of the outbreak. Studies have shown that early and fast diagnosis followed by appropriate hygiene interventions significantly reduces the socio-economic burden caused by norovirus outbreaks. We look forward to the success of RIDASCREEN® Norovirus 3rd Generation EIA and anticipate introducing several Norovirus testing formats in the future to provide laboratories with additional testing options.”

For additional information regarding RIDASCREEN® Norovirus 3rd Generation EIA or the R-Biopharm Group please contact l(dot)murphy(at)r-biopharm(dot)com or call (877) 789-3033.

R-Biopharm is a German based leading developer and producer of test solutions for clinical diagnostics with ISO 13485 / ISO 9001 certification and FDA registration. R-Biopharm possesses many years of sound experience in clinical diagnostics, particularly in the field of infectious stool diagnostics. New standards have been set, for example, by the development of the RIDASCREEN® Norovirus 3rd Generation EIA for the detection of norovirus, the most common viral cause of gastroenteritis outbreaks worldwide. R-Biopharm Inc., the United States operation, is located in Washington, MO.

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Lon Murphy