Bio-Rad Wins FDA Approval for Its D-100 System for A1c Testing

Bio-Rad Receives FDA Clearance for Its D-100 System for A1c Testing

HERCULES, CA--(Marketwired - December 16, 2015) - Bio-Rad Laboratories, Inc. (BIO) and (NYSE:BIO.B), a global provider of life science research and clinical diagnostic products, today announced that its D-100^™System for A1c testing has obtained clearance from the U.S. Food and Drug Administration to monitor the long-term blood glucose control of individuals with diabetes, as an aid in the diagnosis of diabetes, and to help identify those who may be at risk for developing the disease.

The D-100 is a fully automated instrument utilizing high-performance liquid chromatography (HPLC) technology. It is designed to meet the needs of medium and high volume clinical laboratories, for greater throughput, high quality results, and simplified workflow for A1c testing. The system delivers rapid results without sacrificing the ability to detect hemoglobin variants, which can interfere with the interpretation of test results. Earlier this year, Bio-Rad obtained CE marking and released the D-100 System in Europe, Canada, and several countries in Asia-Pacific.

“Bio-Rad is pleased to continue its tradition of helping to manage the global epidemic of diabetes,” said John Hertia, Bio-Rad President, Clinical Diagnostics Group. “Bio-Rad pioneered HbA1c testing over 30 years ago, and our newest platform leverages our expertise in this area to meet our customers’ evolving needs.”

The International Diabetes Federation estimates over 415 million adults worldwide are living with diabetes and this number is expected to increase to 642 million by 2040. Early detection and treatment of diabetes can decrease the risk of developing long term complications resulting from this disease.

About Bio-Rad

Bio-Rad Laboratories, Inc. (BIO) and (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 7,600 people worldwide and had revenues exceeding $2.1 billion in 2014. For more information, please visit www.bio-rad.com.

• Health Care Industry