There is an old saying that seems appropriate when describing Tethys Bioscience's (Emeryville, California) PreDX Diabetes Risk Test: Forewarned is forearmed. The company presented clinical results of the test and reported expanding the tests availability during the American Diabetes Association's (Alexandria, Virginia) annual meeting in San Francisco this past week.

The PreDX Diabetes Risk Test serves as a predictive tool that is said by the company to deliver an accurate assessment of an individual's risk of developing Type 2 diabetes within the next five years. The test is performed exclusively by the Tethys Bioscience Clinical Laboratory on routinely collected blood samples.

The new blood test is designed to help physicians identify patients at highest risk of developing Type 2 diabetes so that they can promote lifestyle changes or initiate treatment plans to prevent or slow progression to Type 2 diabetes. Numerous studies have demonstrated that such interventions can reduce the incidence of new onset diabetes by 30% to 60%.

Using data generated from thousands of patients who were monitored for up to 17 years, Tethys identified specific proteins and other biomarkers that are most predictive of a person's progression to Type 2 diabetes.

"It's a simple blood test, based on analyzing proteins and an integration of multiple risk-defining biomarkers," Mike Richey, chief business officer of Tethys, told Medical Device Daily. "We then put those through an algorithm we designed. From there a risk score is generated from a scale of one to 10. A person scoring an eight would likely have a 40% chance of developing diabetes in five years."

According to statistics diabetes, a preventable and manageable disease, consumes one in five dollars spent toward healthcare in 2007. The total annual economic cost of diabetes in the US in 2007 was estimated to be $174 billion, an increase of over 30% in the past five years.

The U.S. and countries throughout the world face a near-epidemic of diabetes. More than 60 million individuals are at risk for Type 2 diabetes in the US alone, with more than 14.6 million diagnosed and 6.2 million remaining undiagnosed.

"It is already known that we are facing a diabetes epidemic that will only grow worse in the next 10 to 20 years," said Sean Sullivan, director of pharmaceutical outcomes research and policy at the University of Washington (Seattle). "The ability to identify patients at high risk years ahead of disease diagnosis may allow us to halt diabetes progression, saving lives and helping to maintain or improve the quality of life for our patients, while also reducing the overall expenses associated with the disease."

Part of the problem lies with predictability test that aren't convenient for the patient or the physician. Richey said that most diabetes tests on the market are too arduous for the patient to take and doctors seldom use the test until symptoms begin to show.

Take, for example, the Oral Glucose Tolerance Test. In it the patient should have been fasting for the previous 8-14 hours (water is allowed). Usually the OGTT is scheduled to begin in the morning, as glucose tolerance exhibits a diurnal rhythm with a significant decrease in the afternoon. A zero time (baseline) blood sample is drawn.

The patient is then given a glucose solution to drink. The standard dose since the late 1970s has been 1.75 grams of glucose per kilogram of body weight, to a maximum dose of 75 grams. It should be drunk within five minutes. Blood is drawn at intervals for measurement of glucose (blood sugar), and sometimes insulin levels.

The intervals and number of samples vary according to the purpose of the test. For simple diabetes screening, the most important sample is the 2-hour sample and the 0- and 2-hour samples may be the only ones collected. "[PreDX] just has the physician taking the patient's blood and sending it to our lab. In four to five days the patient has the result," he said.

So far a little more than 100 patients have taken the test in the clinical setting, but in the research setting, that number has been in the thousands. Plans call for the test to be widespread by next year.

"We expect a modest ramp in 2008 and in 2009 ... expect to see a robust adoption of this test," Richey said.

Tethys Bioscience is a personalized predictive medicine company developing novel tests which address the growing global healthcare challenge of chronic diseases such as diabetes. It was founded in 2005.