Fujirebio Europe Launches the INNO-LiPA® HCV 2.0 Genotyping Assay, an Efficient Aid to Personalized HCV Therapy

Fujirebio Europe today announced the availability* of the INNO-LiPA HCV 2.0 Genotyping assay. The product, previously distributed by Siemens Healthcare Diagnostics Inc. under the name VERSANT HCV Genotype 2.0, is a line probe assay, for in vitro diagnostic use, designed for the qualitative detection and identification of Hepatitis C virus (HCV) genotypes 1 to 6 and subtypes a and b of genotype 1 in human serum or EDTA plasma samples. Additional subtype information is available in a majority of cases.  

“At Fujirebio we have been pioneering molecular testing solutions since the 1990’s with our high quality LiPA platform,” says Christiaan De Wilde, CEO at Fujirebio Europe. “The historical VERSANT HCV Genotype 2.0 Assay (LiPA) served as an efficient aid to personalized HCV therapy, and we are very pleased to maintain the availability of the test, now officially a part of our INNO-LiPA product range. We would like to extend our gratitude to all INNO-LiPA customers for their continued trust.”  

About Hepatitis C virus  

Hepatitis C virus is one of the leading causes of chronic liver disease, cirrhosis, and hepatocellular carcinoma (primary liver cancer), resulting in major global public health concerns. The HCV infection is unevenly distributed worldwide, with variations in prevalence across and within countries.¹  

Globally, an estimated 50 million people have chronic hepatitis C virus infection, with about 1.0 million new infections occurring per year. WHO estimated that in 2022, approximately 242 000 people died from hepatitis C, mostly from cirrhosis and hepatocellular carcinoma. Early detection and treatment can prevent serious liver damage and improve long-term health.²  

About INNO-LiPA HCV 2.0 Genotyping  

INNO-LiPA HCV 2.0 Genotyping products are IVDR-marked. The available* products are:  

• INNO-LiPA HCV 2.0 Genotyping <20T,CE> (Cat# 81547)
• INNO-LiPA HCV 2.0 Amp <20T,CE> (Cat# 81548)
• INNO-LiPA HCV 2.0 Control <3T,CE> (Cat# 81549)
• LiRAS® for LiPA HCV v4 <CE> (Cat# 15228)

The assay is available in a size of 20T. The test can be performed manually or automated (on the TENDIGO™ (Cat# 80412) instrument) and is not intended to be used as a screening test for HCV or as a diagnostic test to confirm the presence of HCV.  

Visit www.fujirebio.com for more information about this product.  

* Please contact Fujirebio for further information about the local availability of the test.  

References:  

1. Guntipalli P, Pakala R, Kumari Gara S, Ahmed F, Bhatnagar A, Endaya Coronel MK, Razzack AA, Solimando AG, Thompson A, Andrews, K, Enebong Nya G, Ahmad S, Ranaldo R, Cozzolongo R, Shahini E. Worldwide prevalence, genotype distribution and management of hepatitis C. Acta Gastroenterol Belg. 2021 Oct-Dec;84(4):637-656. doi: 10.51821/84.4.015. PMID: 34965046.
2. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

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