Darmstadt, Germany 05-04-2018. R-Biopharm today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its multiplex RIDA®GENE Norovirus GI/GII, a qualitative in vitro multiplex real-time RT-PCR assay for the detection and differentiation of norovirus genogroup I (GI) and II (GII) on the Applied Biosystems 7500 Fast Dx System.
Norovirus is the most common cause of acute gastroenteritis world-wide. Globally norovirus affects about 685 million people every year and 200 million of these cases are among children younger than 5 years old.1 According to the Centers of Disease Control and Prevention norovirus causes 19 – 21 million cases, and contributes 56,000 to 71,000 hospitalizations 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.2 Norovirus outbreaks are difficult to control and result in significant socio-economic burden.
The RIDA®GENE Norovirus GI/GII, a real time RT-PCR Assay is a reliable and accurate method for the detection of norovirus GI and GII in raw or unpreserved stool specimens. The test is easy to perform, provides results in less than 3 hours and is ideal for clinical and public health laboratories in the diagnosis of sporadic and epidemic norovirus GI and GII infections.
Tilmann Bur, Vice President Clinical Diagnostics commented, “ We are very excited to introduce this test to the US market. RIDA®GENE Norovirus GI/GII offers our laboratory customers an accurate and easy to use molecular testing on the Applied Biosystems 7500 Fast Dx System. Nucleic acid extraction is performed on the bioMérieux NucliSENS® easyMAG®. We look forward to the success of RIDA®GENE Norovirus GI/GII and together with the already FDA cleared RIDASCREEN® Norovirus 3rd Generation immunoassay we are proud to provide laboratories several diagnostic solutions. Studies have shown that early and fast diagnosis followed by appropriate hygiene interventions significantly reduces the socio-economic burden caused by norovirus outbreaks. “As Molecular Diagnostics is one key pillar within the cross divisional strategy of R-Biopharm AG, we are proud to bring this internationally successful test to the U.S. clinical market. We anticipate introducing several RIDA®GENE molecular assays in the future to the U.S. market” stated Ralf Dreher, CEO of R-Biopahrm AG.
R-Biopharm AG (Darmstadt, Germany) is a globally active life science company and a leading provider of reliable test systems for clinical diagnostics, companion diagnostics and for analyzing human food and animal feedstuffs.
Since 1988, R-Biopharm has been developing innovative products characterized by top quality, reliability and efficiency. A strong sense of responsibility, long-standing experience and a network of more than 20 affiliated companies and subsidiaries in Europe, the US, Brazil, Latin America, China, India and Australia, as well as more than 120 distribution partners, make R-Biopharm a prime partner for clients from retail, industry and public institutions looking for answers and solutions for current and analytical challenges.
RIDA®GENE Norovirus GI/GII will begin shipping in the United States in June.
For more information contact R-Biopharm AG (info@r-biopharm.de) or visit our website: www.r-biopharm.de
- Centers for Disease Control and Prevention. Norovirus. Norovirus Worldwide. Accessed Mai 04, 2018. https://www.cdc.gov/norovirus/worldwide.html
- 1. Centers for Disease Control and Prevention. Norovirus. U.S. Trends and Outbreaks. Accessed Mai 04, 2018. https://www.cdc.gov/norovirus/trends-outbreaks.html
