Race to Develop Noninvasive Blood Tests Heats Up
May 4, 2000
T he development of a noninvasive blood-analyte testing device, ideally for use at the point of care or even in the home by consumers, has become a hot corporate race with potentially billions of dollars in revenues at stake. No better evidence of how lucrative this market can become—and how close companies are to this reality—is the announcement in March by CME Telemetrix Inc. (Waterloo, ON, Canada) and Motorola (Chicago). The companies announced a nonbinding letter of intent to form a strategic alliance to develop such a monitor. Under the terms of the agreement, Motorola has acquired a worldwide, exclusive license for CME's noninvasive medical devices for measuring glucose and other diabetes-related analytes. CME will retain the right to license the product in Japan only. Motorola will acquire a 6% equity stake in CME, pay to CME an ongoing royalty of 10% on sales of CME's glucose monitoring device, and provide CME with access to any Motorola technology useful in development of the glucose monitoring technology.
"We feel we have selected the perfect corporate partner to assist in the commercialization and miniaturization of CME's proprietary noninvasive glucose monitor," says Duncan J. MacIntyre, president and CEO of CME Telemetrix. "With a global partner like Motorola, CME has access to strong international marketing and world-class manufacturing, critical for the commercial launch of our noninvasive glucose monitor."
CME plans to have a corporate partner in Japan to license its proprietary glucose monitoring technology. It expects to conclude an agreement with a Japanese partner by the end of 2000, says MacIntyre.
The basis of CME's technology is the use of near infrared (NIR) light for noninvasive blood analysis, particularly for home monitoring. CME measurement technology is based on attenuation of visible and near infrared light transmitted through tissue such as that at the end of a finger. Although the initial focus of the company has been on developing a nonivasive blood glucose monitor, other applications of this technology are possible, the company says. They include the noninvasive measurement of analytes, automated blood screening in clinical laboratories, food-quality analysis, environmental safety screening of waste matter, and quality analysis in the pharmaceutical, petroleum, and agricultural industries. CME's technology is also based on advances in optics, electronics, measurement methods, instrument calibration techniques, algorithm technologies, it says.
CME is not the only company going after this lucrative market. Diabetes is estimated to affect more than 100 million people worldwide and is increasing by approximately 15% per year. Perhaps as many as 32 million people in the United States have diabetes; for every person with a known diagnosis there is someone with undiagnosed diabetes, according to the American Diabetes Association.
Moreover, the disease a leading cause of coronary artery disease, blindness, kidney disease, and limb amputations. The cost of treating the complications of diabetes is estimated to be in the region of $200 billion per year worldwide. The costs to society in terms of a patient's shortened life expectancy, as will the individuals' quality of life, are also great.
For years clinicians have sought less and less invasive means of monitoring glucose levels in their patients. Such monitoring is the key to effective management of the disease. A major breakthrough came in the 1960s when relatively inexpensive home monitors came on the scene allowing patients to monitor their blood sugar at home, which boosted management and better patient outcomes considerably. Study after study has shown that regular monitoring of blood glucose levels was the key to disease management.
However, monitoring diabetes is a painful procedure, requiring patients to lance tips of their fingers several times per day to obtain samples of blood to measure their blood glucose level, place drops of blood on test strips and run them through analyzers. Home monitoring also costs patients roughly $1000 per year for supplies and equipment. Several manufacturers are developing noninvasive monitors designed to reduce the cost and pain as well as increase clinical compliance. In addition to CME and Motorola, they include MiniMed Inc. (Sylmar, CA) and Cygnus Inc..
MiniMed's continuous glucose monitoring system was recently approved by FDA for physician use. It uses sensors embedded in the patient's skin in the abdominal region, which monitor and record the glucose levels every five minutes for up to three days. The data is then downloaded periodically in the physician's office.The device is thus designed to supplement patients' own monitoring. However, it will not replace finger prick blood tests, but it is considered to be an important first step toward the development of a wearable, continuous glucose monitor for diabetics.
Another noninvasive product, called GlucoWatch, received positive reports that were presented last summer at the American Diabetes Association Scientific Sessions in San Diego. Manufactured by Cygnus Inc., the device applies a small electric current to the skin, using an AAA battery, and sensors to perform the measurements. A recent study in the Journal of the American Medical Association compared the accuracy of the GlucoWatch with that of serial blood-glucose measurements and found a close agreement between the new device and conventional technologies. In addition, the study demonstrated that the automatic and noninvasive measurements obtained with the GlucoWatch provided more information about glucose levels than the current standard of care.
So important is less invasive means of doing glucose measurements to childhood diabetics that the Juvenile Diabetes Foundation (JDF) issued an extremely supportive statement in December 1999. It said: "Noninvasive and/or minimally invasive blood glucose measurement has the potential to provide valuable information that could result in significant improvements in the treatment of insulin-dependent diabetes and have a positive impact on the quality of life of people with this disease. JDF believes that there is a pressing need for devices capable of measuring blood glucose levels noninvasively or minimally invasively and we have strongly supported research in this area.
"We welcome the efforts by industry to develop these technologies and believe that, if judged by the FDA to be safe and effective, such devices could lead to improvements in the management of diabetes," the statement concluded.—Susan Wallace
