Product Press Release
Bio-Rad Launches Amplichek I Quality Control, the Second in a Series of Controls for the Molecular Diagnostics Testing Market
HERCULES, CA – August 3, 2016 – 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.
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) develops, manufactures, and markets a broad range of innovative products and solutions for the life science research and clinical diagnostic markets. The company is renowned for its commitment to quality and customer service among university and research institutions, hospitals, public health and commercial laboratories, as well as the biotechnology, pharmaceutical, and food safety industries. Founded in 1952, Bio-Rad is based in Hercules, California, and serves more than 100,000 research and healthcare industry customers through its global network of operations. The company employs more than 7,800 people worldwide and had revenues exceeding $2 billion in 2015 . For more information, please visit www.bio rad.com.
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications