A Medical Device Daily

LifeScan (Milpitas, California), maker of the leading OneTouch Brand of blood glucose meters for people with diabetes, and ResMed (Poway, California), a manufacturer of devices for the diagnosis and treatment of sleep apnea, reported an exclusive co-marketing agreement designed to improve the lives of people with Type 2 diabetes and sleep-disordered breathing (SDB). The joint work of the two companies will focus on educational and cross-promotional efforts intended to benefit the patients and healthcare professionals served by both companies. The goal is to build awareness among healthcare professionals of the overlap of these two conditions, trigger new approaches to patient care, and ultimately improve the rate of treating patients suffering from both SDB and diabetes.

The agreement between the two companies comes on the heels of a recent announcement by the International Diabetes Federation (IDF) in which the organization issued a consensus statemen on Type 2 diabetes and obstructive sleep apnea (OSA), the most common form of SDB. Issued by an IDF working group, the new statement included an urgent call-to-action regarding the need to adopt new clinical practices with respect to monitoring, screening and treating patients who present with either condition.

"Through this agreement, it's our hope to make significant inroads into educating more physicians about the coexistence, identification and care of these two diseases, and getting more patients diagnosed, treated and on the road to a healthier future," said Tom West, president-North America, LifeScan.

While more research is needed to fully understand the correlation between diabetes and OSA, it is clear that the two conditions are often linked. "Research shows that it is likely in people with Type 2 diabetes that more than 50% suffer from some form of sleep disorder including sleep apnea," said Paul Zimmet, MD, PhD, co-chair of the IDF working group that issued the consensus statement, and director of the International Diabetes Institute in Melbourne, Australia.

"At the same time," he said, "it is increasingly evident that a significant number of people diagnosed with sleep apnea may have diabetes and they have a significantly greater risk of developing diabetes compared with those that don't suffer from the sleep disorder."

In addition, both conditions are under-diagnosed and, if left untreated and uncontrolled, can lead to serious complications.

Diabetes affects nearly 21 million Americans, with only a little more than two thirds of those having been diagnosed, leaving nearly 6 million unaware that they suffer from the disease and have uncontrolled blood glucose levels. Additionally, 90% to 95% of the diagnosed population has Type 2 diabetes. Without proper management, diabetes can lead to heart disease, stroke, blindness, kidney disease and amputation.

In the US, it is estimated that sleep apnea affects up to 24% of men and 9% of women. Among those believed to have sleep apnea, it also is estimated that at least 90% remain undiagnosed. Left untreated, sleep apnea like diabetes can lead to heart disease, but it can also lead to high blood pressure, fatigue, daytime sleepiness, memory problems, depression, headaches and sexual dysfunction.

LifeScan is a Johnson & Johnson (New Brunswick, New Jersey) company and a maker of blood glucose monitoring products.

In another agreement, Aureon Laboratories (Yonkers, New York) reported a collaborative research effort with Dr. Ignacio Wistuba, associate professor of pathology at the University of Texas M. D. Anderson Cancer Center (Houston). The goal of the study will be to quantitate and evaluate biomarkers that are associated with progression of disease and overall survival.

The project will apply Aureon's systems pathology platform for the analysis of tissues from about 350 non-small cell lung cancer (NSCLC) patients.

Aureon's systems pathology platform applies morphometric imaging to formalin-fixed, paraffin-embedded (FFPE) tissue specimens, enabling quantitation and integration of histological attributes and multiplexed protein biomarkers on a cell-by-cell basis. Additionally, Aureon has developed a multivariate algorithm that integrates histological, molecular and clinical features to establish a comprehensive biometric signature associated with patient outcome. This approach allows for an analysis of histological and molecular information extracted from intact tissue specimens resulting in the identification of phenotypes associated with disease course.

Vijay Aggarwal, PhD, president/CEO of Aureon Laboratories, said, "We are very excited about collaborating with M.D. Anderson. We have previously demonstrated the utility of Aureon's systems pathology platform for the stratification of NSCLC patients treated with Iressa and we look forward to further developing our work in this area. Aureon's ability to integrate and quantify histological features and cell-type specific molecular biomarkers in intact paraffin-embedded tissue allows a better understanding of the biological context in terms of assessing therapeutic response."

Aureon technology also is being used to develop Prostate Px +, a prognostic, biopsy-based test which can assist men who are newly diagnosed with prostate cancer and need more accurate information to guide medical management of the disease. Prostate Px+ was released in May 2008.

Aureon Laboratories' mission is to enable personalized patient care through predictive pathology.