Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global provider of life science research and clinical diagnostic products, today announced its continued expansion into the molecular diagnostics testing market with the launch of Amplichek™ I quality control, which was recently issued a 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Amplichek I will be available in August and is the second in a series of infectious disease controls that Bio-Rad has introduced for the molecular diagnostic testing this year. Molecular diagnostics continues to be one of the fastest growing in vitro diagnostics (IVD) markets, estimated to reach $9.3 billion by 2020, according to a 2015 report by research firm MarketsandMarkets.
“We are pleased to expand our offering of controls for the molecular diagnostics testing market,” said John Hertia, Bio-Rad President, Clinical Diagnostics Group. “The introduction of Amplichek I represents Bio-Rad’s continued commitment to improve laboratory analytical performance and ultimately the quality of patient care.”
Amplichek I is an independent, multi-analyte quality control for the assessment of HIV-1, Hepatitis B (HBV) and Hepatitis C (HCV) nucleic acid tests that can help mitigate the limitations of manufacturer controls. Unlike some controls that are optimized for specific systems, Amplichek I can help reduce the risk associated with reporting inaccurate patient results by monitoring the performance of the complete analytical process and detecting lot-to-lot variation of assay reagents.
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