A research team at the University of Arizona is hard on Tethys' heels

Emeryville firm devises diabetes risk test
[Source: Bernadette Tansey, Chronicle Staff Writer] - An Emeryville biomedical company is about to market a test that it hopes will reduce the terrible health toll of the U.S. diabetes epidemic and, at the same time, slash the nation's costs for medical care.

The diagnostic test to be launched next month by Tethys Bioscience is designed to pick up early signs that a patient will develop the most common type of diabetes - while there's still time to prevent that from happening.

Lifestyle changes such as exercise and a healthier diet have proven to delay the onset of Type 2 or "adult-onset" diabetes, a systemic malfunctioning of energy metabolism that increases the risk of heart attacks, kidney damage, vision loss and other debilitating ailments.

Tethys chief executive Mickey Urdea founded the company in 2002 to develop tests to predict such illnesses so doctors can help their patients ward them off. In addition to diabetes, Tethys has also focused on danger signs for cardiovascular disease and hip fractures. He calls the approach "personalized predictive medicine."

"We think it's the start of a revolution in medical care," Urdea said. "We're spending so much money in this country on diseases, and we don't have to if we can prevent them."

Tethys studied blood samples banked in Finland and Denmark from hundreds of people whose health history was then tracked for years by epidemiologists looking at the onset of diabetes. Among the subjects who developed the disease, Tethys looked for proteins in the blood that were different from those in people who remained free of diabetes. The company found a group of 7 to 15 proteins that, taken together, indicated an increased risk.

Tethys plans to present the data backing its new test on June 6, at the annual meeting of the American Diabetes Association in San Francisco. The association estimates that the total U.S. cost of medical care for diabetes in 2007 was $116 billion. That includes not only treatments such as insulin, but also kidney dialysis, amputations and other measures to deal with the consequences of diabetes. About 20.8 million people in the United States have diabetes, by the association's count. But it also estimates that 54 million more have a condition called prediabetes and may not be aware of it. Damage to the heart and other organs already may be occurring in those people, the ADA says.

Dr. Michael German, clinical director of the UCSF Diabetes Center, said doctors currently have no tool to precisely determine which of their patients are on the road to diabetes. Physicians can estimate the danger by looking at strong risk factors such as obesity, blood glucose levels and a family history of diabetes, he said. Doctors tell all such patients to improve their health habits, but the success rate of such advice is not great, German said. A clear test result warning patients that their individual risk is high could have a significant impact on diabetes prevention, he said.

"Having this information might be a significant motivation for people," German said. In addition to diet and exercise, which are by far the most effective measures, doctors also can prescribe medications to help keep diabetes at bay. German has done consulting work for Tethys.
Urdea said Tethys is likely to be the first company to market a new predictive test for Type 2 diabetes. "We expect competition as time goes on," he said. He estimates that people whose blood shows they're on the high end of Tethys' risk score could be as much as 60 percent more likely to develop Type 2 diabetes within five years.

Tethys plans to seek Food and Drug Administration approval, which might encourage health plans to pay for the test. The company has not yet named a price. But Tethys estimates that each test administered could save health care payers more than $10,000, assuming that patients who find out they are at high risk improve their health habits and avoid the need for expensive diabetes treatments.

That assumption should be tested to see if patients actually would change their ways, said Christian Vaisse, a UCSF associate professor of medicine who studies the genetics of diabetes. The health care system might spend its money more wisely, and benefit more people, by making sure that everyone gets a cheap blood sugar test every year to see if they already have diabetes, he said. Of the 20.8 million people in the United States who have diabetes, about 6.2 million don't know it, the American Diabetes Association estimates. Vaisse said many don't find out until the damage becomes apparent in their eyes, kidneys, nerves or heart.

Vaisse said prediabetes can be detected by an inexpensive oral glucose tolerance test. After the patient swallows a sugar cube, clinicians measure how fast the sugar levels in the blood subside. "It's clear it's not 100 percent predictive, but it is very sensitive," he said.

Urdea said Tethys is continuing to study its test and its potential to improve health care. The company will gauge whether the test, developed through studying patterns among white, middle-aged Europeans, will have the same predictive value in the diverse U.S. population or in children.

A research team at the University of Arizona is hard on Tethys' heels. Professor Serrine Lau at the university's College of Pharmacy said she and her colleagues are about six months away from finishing work on their own test for Type 2 diabetes risk. Their test detects a modification in blood proteins when the level of glucose in the blood starts to get too high, she said. Chains of sugar molecules are grafted onto the proteins as the body tries to absorb the excess glucose.

Lau said, however, that the Tethys team is also taking the right approach toward finding a predictive test for diabetes. Having several different tests could be a boon to medical treatment and research, she said. Comparisons among the results of different tests can help validate the data and lead to new insights, Lau said.

"They could be very complementary," she said.