Diabetes Testing on High-Throughput Analyzer Files for FDA Approval

The cobas c513 analyzer has been submitted to the US Food and Drug Administration (FDA) for approval as a dedicated, high-throughput HbA1c testing solution to help laboratories meet increasing testing needs for people with diabetes.

The cobas c513 analyzer from Roche (Basil, Switzerland) is based on the proven, trusted cobas technology developed in cooperation with Hitachi High-Technologies (HHT). The HbA1c test is a longer term measurement of blood sugar levels used to determine if a person has or is at risk of developing diabetes. Set to run on the established Tina-Quant HbA1c A1cDx Gen.3 test, which is also used across the Roche laboratory HbA1c portfolio, the cobas c513 will ensure high-quality results and comply with current guidelines and recommendations for HbA1c testing and measures A1c as defined by the IFCC.

cobas c513 features direct results reporting, thereby minimizing risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. This feature will help save valuable time and laboratory resources, while ensuring high-quality results. Furthermore, cobas c513 will provide a higher on-board test capacity, enabling laboratories to load the analyzer with more tests at a time, save lab space, minimize resources, and ensure a smooth workflow. It offers closed tube sampling, which will reduce hands-on time, prevent sample contamination, and ensure operator safety for laboratory personnel.

The prevalence of diabetes has increased, 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 53% until 2035. Over half of all cases are preventable.

"As the prevalence and incidence of diabetes continues to grow, it's estimated that by the end of this decade 15% of American adults—or roughly 39 million people will be affected. This staggering number is not only a major cause for concern for healthcare providers, but for healthcare organizations as well," said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation, "With the submission of the cobas c513 analyzer to the FDA for 510(k) clearance, Roche is dedicated to helping address the need to quickly identify, diagnose, and monitor people with diabetes."

Upon receiving FDA clearance, Roche plans to replace its existing analyzer, the COBAS INTEGRA 800 CTS, which has been a successful and well-established solution. The cobas c513 analyzer will further increase efficiency by doubling the already market-leading throughput of the COBAS INTEGRA 800 CTS from 200 to 400 patient results per hour. cobas c513 will achieve this performance with the same space footprint.

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