The Urgent Need for Non-Invasive, Point-of-Care Screening Methods
Diabetes is a serious, chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar, or glucose), or when the body cannot effectively use the insulin it produces. Diabetes is an important public health problem, one of four priority noncommunicable diseases (NCDs) targeted for action by world leaders. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.
According to the World Health Organization (WHO), an estimated 422 million adults were living with diabetes in 2014, compared to 108 million in 1980. The global prevalence (age-standardized) of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population. This reflects an increase in associated risk factors such as being overweight or obese. Over the past decade, diabetes prevalence has risen faster in low- and middle-income countries than in high-income countries.
Diabetes caused 1.5 million deaths in 2012. High blood glucose caused an additional 2.2 million deaths, by increasing the risks of cardiovascular and other diseases. Forty-three percent of these 3.7 million deaths occur before the age of 70 years. The percentage of deaths attributable to high blood glucose or diabetes that occurs prior to age 70 is higher in low- and middle-income countries than in high-income countries. Diabetes of all types can lead to complications in many parts of the body including heart attack, stroke, kidney failure, leg amputation, vision loss and nerve damage.
Multiple studies have shown that much of diabetes can be prevented or delayed if detected early. Current screening methods are inadequate in that late diagnosis is significantly driven by the need for a blood draw, the requirement to fast, or a trip to the lab. This situation is even more pronounced in developing countries, where the WHO report less than 50% have access to technologies and procedures useful for early detection, diagnosis and management of diabetes and its complications such as oral glucose tolerance test, glycated haemoglobin (HbA1c) test, and others.
In the U.S., the American Diabetes Association says that diabetes affects nearly 30 million individuals – or roughly 10% of the population – with about 27% of those cases going undiagnosed. There are also approximately 80 million Americans additionally estimated to be pre-diabetic, with 90% being completely unaware of their condition. Diabetes is the seventh leading cause of death in the U.S. responsible for about 70,000 deaths in 2010 alone, and diabetes and its related complications accounted for $245 billion USD in total medical costs and lost work and wages in the U.S. in 2012.
The Canadian Diabetes Association says that more than 9 million Canadians live with diabetes or pre-diabetes, that approximately 80% of people with diabetes will die as a result of heart disease or stroke, and that it is a contributing factor in the deaths of approximately 41,500 Canadians each year. Canadian adults with diabetes are twice as likely to die prematurely, compared to people without diabetes, and the life expectancy for people with type 2 diabetes may be shortened by 5 to 10 years. The financial burden of diabetes and its complications is also enormous. People with diabetes incur medical costs that are two to three times higher than those without diabetes. A person with diabetes can face direct costs for medication and supplies ranging from $1,000 to $15,000 a year in extreme cases. By 2020, it’s estimated that diabetes will cost the Canadian healthcare system $16.9 billion annually.
Current guidelines generally recommend patients aged 40 or older should be tested approximately every three years, while those with any risk factors including being overweight, physically inactive, or having high blood pressure should be tested earlier and more frequently.
The World Health Organization states that cardiovascular diseases (CVDs) are responsible for more than 30% of all deaths worldwide, and the number is expected to grow to 23.6 million deaths annually by 2030. Of these, coronary artery disease (CAD) is responsible for more than 7 million heart attacks globally each year. There are more than 540 million blood cholesterol tests performed annually to help prevent one of the largest causes of death in the world.
According to the American Heart Association heart disease remains the nation’s leading cause of death in the U.S., a ranking it has held since 1921 (stroke still ranks fourth). An estimated 85.6 million people in the U.S. are living with cardiovascular diseases, including heart attack, stroke, high blood pressure and chest pain. Among U.S. adults, 32.6 percent—about 80 million—have high blood pressure.
Despite an overall 30.8 percent drop in cardiovascular disease death rates from 2001 to 2011, the high blood pressure death rate increased 13.2 percent over that same time. The cost of heart disease in the U.S. alone is estimated to exceed $108 billion annually.
The Heart and Stroke Foundation of Canada states that more than 70,000 heart attacks occur annually (one event every seven minutes) resulting in over 16,000 deaths. There are 45,000 cardiac arrests each year (where the heart actually stops) or one every 12 minutes. Nearly 85% of cardiac arrests happen in homes or public places, and it is estimated that 25% of patients with sudden death or nonfatal myocardial infarction experience no prior symptoms.
Many of the first coronary events experienced, if not fatal, are disabling and/or require lengthy and costly medical care. At the same time, the evidence that most cardiovascular disease is actually preventable continues to strengthen. Most patients who develop CAD have at least one major CAD risk factor such as unfavourable blood cholesterol levels; elevated blood pressure; cigarette smoking; diabetes; or adverse dietary habits. Consequently, identifying these patients with subclinical cardiovascular disease who could benefit from more intensive primary prevention measures to prevent a first event is crucial
Current guidelines generally recommend that risk factor assessment in adults should begin as early as age 20 and that all adults who are 40 or over should know their absolute risk of developing CAD.
Luminor believes that the key to bringing these numbers down is earlier screening for diabetes and coronary artery disease through the introduction of non-invasive, user-friendly and rapid screening technologies. The goal of the Luminor screening technologies is to provide patients at risk with an early distance warning and to serve as a tipping point for individuals to take real-time action and follow-up with their healthcare providers for immediate, effective and ongoing management of their conditions, whatever the stage. Non-invasive screening allows for faster, earlier testing and greater patient turnaround, as well as a pain free alternative that doesn’t require needles, fasting, bloodwork, or waiting. Widespread access to these new and innovative technologies – which are also highly mobile, affordable, and cost-effective – could significantly increase early screenings worldwide, leading to positive impacts for patients, physicians, and the healthcare economy overall.
The Company’s commercialization strategy is global in vision and includes working with distribution partners. In the long term, the Company also intends to build its case for government/private insurance reimbursement in multiple markets.