ELITechGroup’s blood-borne virus (BBV) panel received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
- The ELITe BBV panel was launched in 2022 and comprises three quantitative IVD assays targeting Human Immunodeficiency virus-1 (HIV-1), Human Hepatitis B Virus (HBV), and Human Hepatitis C Virus (HCV)
Turin, June 13, 2024: ELITechGroup is proud to announce today the successful approval of its BBV Panel for the Japanese market. ELITechGroup offers a fully automated PCR solution to test the BBV panel, which includes quantitative assays for monitoring of Human Immunodeficiency Virus (HIV-1), Human Hepatitis B Virus (HBV), and Human Hepatitis C Virus (HCV). The HBV and HCV assays received approval under Japan’s Pharmaceuticals and Medical Devices Act (PMDA) in March, followed by the HIV-1 assay in June.
Japan’s PMDA is renowned for its rigorous registration process for foreign in vitro diagnostic (IVD) manufacturers, making this approval a reflection of the high-quality standards of ELITechGroup’s IVD products.
The BBV assay panel has been validated in Japan in combination with the ELITe InGenius, sample-to-result instrument.
Since its launch at the end of 2022, ELITechGroup has partnered with reference laboratories to evaluate the performance of its panel against market benchmark assays demonstrating excellent performances.
This announcement underscores a crucial milestone in ELITechGroup’s mission to provide state-of-the-art diagnostic solutions, further solidifying its determination for the global relevance of high-quality molecular diagnostic solutions.
About ELITechGroup
ELITechGroup, part of Bruker Corp.,is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.
ELITech Molecular Diagnostics (MDx) serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including nearly 60 CE-IVD assays and instruments as well as software applications.