Roche introduces the first globally-available HbA1c test for diagnosing diabetes

Rotkreuz/Switzerland, 26 August, 2013

The FDA has approved the Tina-quant HbA1cDx Gen. 2 assay as an aid in diagnosing diabetes

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the worldwide commercial availability of the Tina-quant HbA1cDx Gen.2 laboratory test, which aids healthcare professionals in diagnosing and monitoring diabetes in addition to identifying at-risk patients. Thanks to this new test, which will be commercially available in the third quarter of 2013 as part of the COBAS INTEGRA 800 clinical chemistry analyzer, physicians can now conduct instant testing without needing patients to be in a fasted state.

Roche’s Tina-quant HbA1cDx Gen.2 test meets specific performance criteria that make identifying and managing individuals with diabetes mellitus easier.

“Measuring HbA1c enables healthcare professionals to identify undiagnosed cases of diabetes and will help them find the best treatment before late complications become a problem. In addition, they benefit from easily indexing a patient’s hemoglobin glycation in real time, without time-consuming and staff-intensive post-analytical steps. This improves clinical workflows, saves time and even costs, representing a step-forward in the management of diabetes mellitus,” stated Randy Pritchard, Senior Vice President Core Reagents of Roche Professional Diagnostics.

Due to the high specificity of the reagent, this test is not affected by interferences from common hemoglobin variants such as HbS, HbE, HbC, and HbD. For this reason, the Tina-quant HbA1cDx Gen.2 test delivers accurate results that help healthcare professionals manage patients reliably. The reporting in IFCC units (mmol/mol) and derived NGSP units (% HbA1c) eliminates any confusion for the healthcare professional. Furthermore, this test is used as a reference method in NGSP Network Laboratories, an association that favors the standardization of HbA1c testing.

About HbA1c testing

Hemoglobin A1c (HbA1c), also called glycated hemoglobin, is a blood test which indicates the onset of diabetes or identifies individuals at risk. Originally, this test enabled healthcare professionals to better monitor glycemic control in patients with diabetes and to adapt medication if necessary.

Results from the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS) pointed out that HbA1c testing works as a fundamental diagnostic tool for managing patients with diabetes, as intensive glycemic control significantly reduces the risk of long-term complications. For the first time, these trials enabled diabetologists to establish specific treatment goals based on HbA1c testing results.

For decades, the identification of individuals with diabetes has been done either by measuring values of fasting plasma blood glucose (FPG) or by evaluating a two-hour blood glucose concentration test with an oral glucose tolerance test (OGTT). In 2009, the American Diabetes Association recommended using HbA1c to diagnose diabetes, with levels of ≥ 6.5% for diagnosis and levels 5.7% to 6.4% as an indication of increased risk. Compared with FPG and OGTT, HbA1c measurement is less affected by day to day variation of blood glucose levels because it always reflects an average blood glucose level of the last 90 to 120 days.

About diabetes mellitus

Diabetes mellitus is a chronic metabolic disease that is associated with severe complications and risks for patients, in addition to imposing significant costs on healthcare systems. Diabetes is characterized by high blood glucose levels and the inability of the body to produce insulin or use insulin properly. Complications from diabetes, such as coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness, are resulting in increasing disability, reduced life expectancy and enormous health costs for virtually every society. Based on the latest data from the International Diabetes Federation (IDF), more than 370 million people worldwide are affected, including an estimated 180 million who are undiagnosed.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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