SOURCE: Bio-Rad Laboratories

Bio-Rad Laboratories

June 09, 2015 16:27 ET

Bio-Rad Announces FDA Clearance for Diagnosing Diabetes With Its VARIANT II TURBO HbA1c Kit - 2.0

HERCULES, CA--(Marketwired - Jun 9, 2015) -   Bio-Rad Laboratories, Inc. (NYSE: BIO) (NYSE: BIO.B), a global provider of life science research and clinical diagnostic products, today announced that its VARIANT™ II TURBO HbA1c Kit - 2.0 has obtained 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. This approval enhances the traditional use of the instrument by also providing the ability to screen and diagnose diabetes.

The VARIANT II TURBO HbA1c Kit - 2.0 provides HbA1c (A1c) results quickly and efficiently. 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 VARIANT II TURBO HbA1c Kit - 2.0 to help diagnose and identify 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.

Diabetes is a chronic disease that is associated with high blood glucose. Uncontrolled diabetes can lead to severe complications such as 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 do not know they have the disease.

"Bio-Rad has provided industry-leading products for diabetes monitoring for more than 30 years and we are pleased to continue this tradition with FDA clearance of our VARIANT II TURBO HbA1c Kit - 2.0," said John Hertia, Bio-Rad Executive Vice President, President, Clinical Diagnostics Group. "Early detection of pre-diabetic or diabetic status can help those at risk delay or even prevent the progression of this disease."

The VARIANT II TURBO HbA1c Kit - 2.0 delivers precise measurement of A1c with hemoglobin variant detection. Hemoglobin variant detection 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.

About Bio-Rad

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 7,600 people worldwide and had revenues exceeding $2.1 billion in 2014. For more information, please visit

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