Bio-Rad Receives FDA Clearance to Aid in Diagnosing Diabetes with its D-10 Hemoglobin A1c Program


Press Release

HERCULES, Calif. – July 28, 2017 – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global provider of life science research and clinical diagnostic products, today announced that its D-10 Hemoglobin A1c Program has received clearance from the U.S. Food and Drug Administration for use as an aid in diagnosing diabetes and identifying people who may be at risk for developing the disease. The approval enhances the traditional use of the D-10 Hemoglobin Testing System by providing the ability to aid in diagnosis of pre-diabetes and diabetes.

The D-10 Hemoglobin A1c Program provides accurate HbA1c (A1c) results for patient health improvement. The A1c test, considered the gold standard in monitoring the blood glucose (blood sugar) levels of diabetics over time, lets physicians know whether or not their patients are in compliance with their treatment — a combination of diet, exercise, and medication.

"Using the D-10 Hemoglobin A1c Program to aid in diagnosing and identifying those who may be at risk of developing the disease offers critical health information at an earlier stage, helping doctors diagnose people living with diabetes before they have symptoms," said John Hertia, Bio-Rad Executive Vice President and President, Clinical Diagnostics.

Diabetes is a chronic disease associated with high blood glucose. Uncontrolled diabetes can lead to severe complications including heart disease, stroke, and blindness. The International Diabetes Federation estimates that the number of people living with diabetes will increase to 592 million by 2035 and that 1 in 2 people with diabetes are not aware they have the disease

About the D-10 Hemoglobin A1c Program
The D-10 Hemoglobin A1c Program offers a complete patient picture to aid healthcare providers in making the appropriate diagnosis as well as initiating proper treatment. The program delivers precise measurement of A1c with hemoglobin variant detection (HbS, HbC, HbD and HbE), which helps identify those patients with a hemoglobinopathy—a condition that may not otherwise be readily apparent—that could lead to the misinterpretation of a patient's A1c results. Being able to detect a hemoglobin variant is critical to helping doctors determine if an A1c result should be used to diagnose a patient with diabetes.

Bio-Rad and the D-10 are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions.

About Bio-Rad
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 8,350 people worldwide and had revenues exceeding $2 billion in 2016. For more information, please visit

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Press contact:
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications