Bio-Rad Unveils Amplichek II Quality Control, the First in a Series of Controls for the Molecular Diagnostics Testing Market
(firmenpresse) - HERCULES, CA -- (Marketwired) -- 05/23/16 -- Bio-Rad Laboratories, Inc. (NYSE: BIO) (NYSE: BIO.B), a global provider of life science research and clinical diagnostic products, today announced its entry into the rapidly growing molecular diagnostics testing market with the launch of Amplichek™ II quality control, which was recently issued a de novo clearance from the U.S. Food and Drug Administration (FDA).
The FDA''s de novo clearance is a classification given to devices that are considered novel, with no existing classification or predicate device on the market. Amplichek II began shipping in May and is the first in a series of infectious disease controls that Bio-Rad plans to introduce for the molecular diagnostic testing market. Molecular diagnostics is one of the fastest growing IVD markets, estimated to reach $9.3 billion by 2020 with the infectious disease segment accounting for the largest share of the global market, according to a 2015 report by research firm MarketsandMarkets.
"Our Amplichek II quality control complements our already extensive range of quality controls and reflects our commitment to offer innovative products that help improve laboratory analytical performance," said John Hertia, Bio-Rad President, Clinical Diagnostics Group.
Amplichek II is an independent, multi-analyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Healthcare Associated Infections (HAIs). HAIs can occur during the process of patient care within a healthcare facility. Millions of Healthcare Associated Infections occur each year, leading to significantly high mortality rates. According to the Centers for Disease Control and Prevention, on any given day, about one in 25 hospital patients have at least one Healthcare Associated Infection. Early detection of these pathogens combined with the appropriate infection control procedures can help prevent the spread of HAIs and lead to improved patient care.
Bio-Rad Laboratories, Inc. (NYSE: BIO) (NYSE: BIO.B) 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
This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding plans to introduce products to the molecular diagnostics testing market and our development and launch of new products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management''s Discussion and Analysis of Financial Condition and Results of Operation" in Bio-Rad''s public reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2016. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.
Bio-Rad Laboratories, Inc.
Tina Cuccia
Corporate Communications
510-724-7000
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Datum: 23.05.2016 - 06:30 Uhr
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