Such a small, non-invasive glucose monitor would capture and transmit data to the Cloud, making it feasible for clinical laboratories to collect those tests results, and keep a record of each patient’s glucose results
Probably no single area of medical laboratory testing has the greatest potential to help the largest number of patients with a chronic disease—and make a lot of money for the in vitro (IVD) manufacturer who is first to market with the right diagnostic product—than glucose testing and continuous glucose monitoring (CGM). Pathologists and clinical laboratory managers know why this is true.
Reports from the Centers for Disease Control and Prevention (CDC) and the American Diabetes Association, state that more than 29 million Americans (about 9% of the U.S. population) have diabetes. Nearly 28% of these (about eight million) are undiagnosed. The reports also stipulate that fasting glucose or A1C levels have shown that more than 80 million people over the age of 20 were prediabetic in 2012. Based on trends since then, we can safely assume that the number of prediabetics in America has grown. And what is true in the United States is general true in most developed nations throughout the world. (more…)
Retail clinics ready to expand into chronic disease management and that can be a threat or an opportunity for clinical laboratories
Dark Daily has often predicted that rapid clinics in retail stores would actively look for opportunities to add specific medical laboratory tests to their on-site service menus. Now the largest retail clinic in the U.S. is set to deploy hemoglobin A1c (HbA1c) testing analyzers in its 600 retail clinic sites throughout the United States.
This deal was announced in November between MinuteClinic, a division of CVS Caremark Corporation (NYSE:CVS), and Axis-Shield plc (LSE:ASD, OSE:ASD), of Dundee, Scotland. The agreement calls for MinuteClinic to use Axis-Shield’s Afinion analyzer in all 600 of its clinic locations across the nation. The system’s HbA1c assay is CLIA-waived. The fully automated analyzer will allow MinuteClinic’s providers to collect a patient specimen and get the results of the hemoglobin A1c tests in as little as three minutes.
Of course, the business strategy here is to add the clinical services necessary so that providers can serve patients with diabetes in these retail clinic settings. This represents a sizeable market. According to the 2011 National Diabetes Fact Sheet, there are 25.8 million adults and children with diabetes, and only 18.8 million have been diagnosed. Of greater interest for clinical laboratory managers and pathologists, 79 million Americans are considered pre-diabetic and, in 2010, 1.9 million new cases of diabetes were diagnosed among individuals who are 20 years and older.