Abacus Diagnostica Receives CE Mark for the World's Fastest Molecular Tests for Norovirus GI and GII - and Expands Distribution Network

HELSINKI, Finland, October 10, 2017 /PRNewswire/ --

Abacus Diagnostica Oy announces that it has received the CE mark for the GenomEra® Norovirus. The IVD test is the world's fastest molecular test for the detection and differentiation of norovirus genogroups I and II. The new test runs on the fast, cost-effective and automated GenomEra CDX platform.

The proper diagnostics plays a key role in preventing norovirus infections, as there are no vaccines or preventive medicine available. The low infectious dose, short incubation period and environmental persistence makes noroviruses extremely contagious. Norovirus outbreaks lead easily to ward, school or restaurant closure. Globally, annual societal costs of norovirus infections are estimated to be $60.3 bn1. 

"Until recent years Norovirus diagnostics has been challenging and most of the cases are still diagnosed by clinical symptoms. Molecular tests are the only in vitro diagnostic tests, which can detect virtually all norovirus variants and are sensitive enough to detect all infections despite the severity. GenomEra enables adaptation of quick and reliable norovirus diagnostics also in places with limited resources, and is so easy, that it can be used without any experience of molecular methods" Says Erno Sundberg, CEO of Abacus Diagnostica.

"Our team has once again done great work and as a result we are now proud to launch the first commercial molecular norovirus test directly from stool without RNA extraction. We have now successfully applied our proprietary chemistry for the detection of RNA viruses with one the most challenging tests to make. The product portfolio extension for other RNA viruses such as influenza is now a straightforward process."

New distributors

Abacus Diagnostica has improved the availability of GenomEra products by signing new distribution agreements. The most important one has been signed with UK based Launch Diagnostics, a leading supplier of diagnostic solutions and innovations.

"Launch Diagnostics Ltd is pleased to be partnering with Abacus Diagnostica to supply the GenomEra CDX instrument and Norovirus kits in the UK, Ireland, France and Benelux. Norovirus outbreaks are major concern - by the 8th of September, Public Health England has recorded 215 norovirus outbreaks during 2017, and which 93% of those has led to ward/bay closure. Such outbreaks can be crippling to hospitals so rapid, reliable diagnosis with a test like the GenomEra Norovirus kit can dramatically improve patient care and save hospitals money." Says Launch Diagnostics' Marketing Director & Directrice France et Benelux, Veronique Petit.

About Abacus Diagnostica

Abacus Diagnostica Oy is a Finnish molecular diagnostic company, which has commercialized its proprietary GenomEra® platform. GenomEra CDX system has proven to be one of the fastest, easiest-to-use and the most cost-effective automated solution for molecular diagnostics (MDx) of infectious diseases. GenomEra is suitable also for small to mid-size customers without any prior experience in MDx. Abacus' vision is to provide cost-effective and easy-to-use products to enable MDx also in resource and capability limited settings.

For more information, visit www.abacusdiagnostica.com

1: Bartsch SM, et al. (2016). Global Economic Burden of Norovirus Gastroenteritis PLoS ONE 11(4):e0151219.

Contact:

Abacus Diagnostica Oy

Erno Sundberg

[email protected]

CEO

+358-0207188388

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