Bayer’s point-of-care testing system delivers quick and accurate results.

Leverkusen/Barcelona, February 8, 2012 – A new study(1) presented at the 5th International Conference on Advanced Technologies and Treatments for Diabetes in Barcelona found that A1CNow+®, Bayer’s point-of-care testing system for glycated hemoglobin (HbA1c) demonstrated precision and comparable accuracy to a standard laboratory system, the HPLC analyzer G8 from Tosoh. Results for both analyzers were seen as comparable despite minor and insignificant statistical differences.

Bayer’s A1CNow+ glycated hemoglobin analyzer is a small system requiring a single drop of blood (5 microL). The system is based on Bayer’s enabling technology that incorporates microelectronics, optics and dry-reagent chemistry strips within a reusable, self-contained, integrated monitor and a single-use test cartridge. A1CNow+ is easy-to-use and allows for finger stick or venous blood draw testing and immediate, in-office HbA1c results as compared to more time-consuming lab analysis methods.

The study’s investigators Dr. Jose Luis Bedini and Dr. Josep Maria Jou of the Core Laboratory at the Hospital Clinic in Barcelona, Spain concluded that Bayer’s A1CNow+ glycated hemoglobin analyzer “could be a useful solution for quick and accurate results of HbA1c at doctor’s offices, emergency labs and other locations”.

About the study

57 patient samples were evaluated. All samples were processed in duplicate to determine precision. Three different sample batches were employed. The samples were obtained from lithium heparin anticoagulated blood. The results were compared with those obtained using the Tosoh G8 analyzer. The statistical methods used linear regression (LR), correlation coefficient (r), Bland-Altmann differences test, and Passing-Bablock (P-B) regression.

The results of the study between duplicates showed: N = 57, r = 0.918, mean difference = –0.09. Linear Regression (LR) = slope 0.865 and Intercept (I) 0.70, Passing-Bablock (P-B) = slope 1.000 and I –0.10. The value provided by the Tosoh G8 was taken as reference value. N = 57, r = 0.922, mean difference = –0.249, LR = slope 0.996 and I –0.23, P-B = slope 1.000 and Intercept –0.30. The precision of the duplicates was relevant as evidenced by a small difference (-0.09) and a regression slope = 1.000. Results for both analyzers were comparable despite minor and insignificant statistical differences of –0.2.

About HbA1c

HbA1c, also known as glycated hemoglobin, is formed when glucose in the blood binds irreversibly to hemoglobin to form a stable glycated hemoglobin HbA1c complex. Since the normal life span of red blood cells averages about 120 days, the HbA1c level will change as new red blood cells are made. HbA1c values are directly proportional to the average concentration of glucose in the blood over the past two to three months. HbA1c values are not subject to the daily fluctuations that are seen with blood sugar monitoring.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55.700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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(1) Bedini JL, Jou JM, Evaluation of the point of care A1CNow+ analyzer for HbA1c; poster presented at the 5th International Conference on Advanced Technologies and Treatments for Diabetes, Barcelona, February 8-11, 2012