Newswise — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new dedicated, high-throughput HbA1c testing solution, the cobas c 513 analyzer, and HbA1c Gen. 3 assay has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
“As diabetes continues to approach epidemic proportions in the U.S. with an estimated 1.4 million American adults being diagnosed annually, the demand on healthcare providers and healthcare systems to keep up with this challenging health issue continues to increase,” said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. “With the FDA approval of the new cobas c 513 analyzer and proven HbA1c Gen. 3 assay, Roche is now positioned to help healthcare organizations address the increasing need for HbA1c testing with a dedicated solution that enables them to consistently deliver confident, efficient and high-quality results.”
About the cobas c 513 analyzer
The cobas c 513 analyzer further increases laboratory efficiency by doubling the throughput to 400 patient results per hour with the same footprint as the COBAS INTEGRA® 800 CTS, which it replaces. Additionally, the cobas c 513 analyzer features direct results reporting, thereby minimizing the risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. The analyzer also provides a high on-board test capacity of up to 18,000 tests and features closed tube sampling for greater lab efficiencies and maximum operator safety.
About the HbA1c assay—a new standard in testing performance and efficiency
The cobas c 513 analyzer runs the established Roche Tina-quant® HbA1c Gen.3 assay, which is also used across the Roche laboratory HbA1c portfolio, to ensure confidence, efficiency and high-quality results. It complies with current guidelines and recommendations for HbA1c testing and measures A1c as defined by IFCC/NGSP reference methods. With no interference by most known HbA1c variants, the Roche Tina-quant HbA1c Gen. 3 assay delivers accurate monitoring of HbA1c levels and results that clinicians and patients can have confidence in.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare–a strategy that aims to fit the right treatment to each patient in the best way possible.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. 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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