Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new, dedicated high-throughput HbA1c testing solution, the cobas c 513 analyser, is now available for countries accepting the CE mark[i].
“The increasing number of people with diabetes is challenging healthcare providers and is putting a significant strain on healthcare systems,” said Roland Diggelmann, COO, Roche Diagnostics. “With the cobas c 513, Roche is meeting the dedicated and growing testing needs of our customers.”
With the new cobas c 513 analyser, Roche is replacing its existing dedicated HbA1c analyser, the COBAS INTEGRA 800 CTS, which has been a successful and well-established solution. The cobas c 513 analyser further increases laboratory efficiency by doubling the already market-leading throughput of the INTEGRA 800 CTS from 200 to 400 patient results per hour. The cobas c 513 achieves this performance with the same footprint.
The cobas c 513 features direct results reporting, thereby minimising the risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. This saves valuable time and laboratory resources while ensuring high quality of results.
Furthermore, the cobas c 513 analyser provides a higher on-board test capacity. Enabling laboratories to load the analyser with more tests at a time saves laboratory space, releases lab resources and ensures a smooth workflow. The new analyser also offers closed tube sampling, which reduces hands-on time, prevents sample contamination and ensures operator safety for laboratory personnel. Further details about the regional launch will be provided at a later date.
The prevalence of diabetes has increased significantly in recent years, with estimates of as many as 566 million people with diabetes worldwide, of which 32% may still be undiagnosed. The total number of people with diabetes is anticipated to increase by a further 53% until 2035, putting a significant strain on healthcare providers. Over half of all cases of diabetes are preventable.
About the cobas c 513 analyser and the HbA1c test
HbA1c is a longer-term measure of blood sugar levels, which is used to determine if a person is diabetic or at risk of developing diabetes. The cobas c 513 analyser runs the established Tina-Quant HbA1c A1cDx Gen.3 test, which is also used across the Roche laboratory HbA1c portfolio, to ensure high quality of results. It complies with current guidelines and recommendations for HbA1c testing and measures A1c as defined by IFCC. With no interference by most known HbA1c variants, Roche’s Tina-quant HbA1c assay delivers accurate monitoring of HbA1c levels and results that clinicians and patients can have confidence in[ii]. Moreover, Roche’s Tina-Quant HbA1c was the first test cleared for diagnosis of diabetes by the FDA.
The cobas c 513 analyser is based on the proven and trusted cobas technology developed in cooperation with Hitachi High-Technologies (HHT).
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, immunology, infectious diseases, ophthalmology 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 diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. 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 chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 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.[i] Local product availability may vary independently from CE mark approval. [ii] HbA1c Assay Interferences. NGSP. September 2014. http://www.ngsp.org/interf.asp. Accessed January 14, 2015