DiaSorin, Saluggia, Italy, has received FDA approval for the 6 assays that complete the Liaison XL Hepatitis menu offering in the United States. DiaSorin’s full offering of the Hepatitis B (HBV) panel will allow a complete HBV testing solution that is key, not only to identify infected individuals, but also to diagnosing the presence of the virus, avoiding the spread of the infection, and optimizing patient management.
HBV is a vaccine-preventable liver infection. For some people, it is an acute or short-term illness, but for some others it can become a long-term chronic infection, which leads to serious health issues, like cirrhosis or liver cancer. Worldwide, approximately 2 billion people are infected by HBV.
Through the approval of the full HBV panel, DiaSorin is now able to offer a complete testing solution for Hepatitis A (HAV total, HAV IgM), Hepatitis B (Anti-HBs, Anti-HBc, Anti-HBe, HBeAg, HBcIgM, and HBsAg), and Hepatitis C (HCV Ab) in the US market.
“The approval of our full Hepatitis menu in the U.S. is consistent with our strategy to address the hospital labs’ market, reinforcing our positioning as a supplier of both mainstream and specialty infectious diseases tests,” says Chen Even, chief commercial officer of the DiaSorin Group. “We are one of only two vendors in the U.S. to offer a complete hepatitis solution on a single platform, including a fully automated HBe antibody assay for the best patient management and we continue to be a leader in innovation with our HBsAg assay, which detects all genotypes, serotypes, and mutations for the most accurate diagnosis of HBV.”
DiaSorin’s hepatitis testing solution combines over 40 years of experience in hepatitis serology with the full automation of the Group’s CLIA technology. The tests are designed to be performed on the more than 5,000 Liaison XL platforms installed worldwide.
The approval of the Hepatitis B panel falls within the agreement signed with Beckman Coulter back in 2016, when the two groups formed a strategic partnership to bring the Liaison XL Hepatitis and HIV products to the US market. Since then, the companies have worked together toward FDA approval and commercialization in the United States of the full line of Hepatitis (A, B, C) and HIV assays already available to DiaSorin customers outside the United States.
“I’m proud that the U.S. Food and Drug Administration has approved the commercialization of our six HBV tests, recognizing again our ability to provide innovative, high quality and highly technological diagnostic solutions,” says Carlo Rosa, CEO of the DiaSorin Group. “These new tests will be manufactured in our Italian and U.K. facilities and will be added to our existing and already available hepatitis panel in the U.S., strengthening our positioning as diagnostic specialists at service of hospital laboratories.”
For more information, visit DiaSorin.
