Tethys predicts your potential diabetic future

Suppose a simple blood test were to tell you that you’ve got a better than 50 percent chance of developing “type 2” diabetes — a form of the disease long associated with age and obesity — within the next five years. Would you make the recommended lifestyle changes, by eating right and exercising more? Would you even consider starting lifelong medication that might postone or prevent the disease entirely?

These are the sorts of choices that Tethys Bioscience, an Emeryville, Calif., biotech, would like to force on you before much longer. Tethys is preparing to launch a new diagnostic test — dubbed Diabetes PreDx (“dx” is a common medical abbreviation for “diagnostic” or “diagnosis,” although here it’s pronounced in a way that sounds like “predicts”) — that it says can accurately identify people who are most at risk of developing diabetes. The company plans to launch the test in a preliminary version later this month, with a full rollout planned for June.

The Tethys approach is conceptually simple, if still somewhat breathtaking on a practical level. Diabetes PreDx measures a patient’s blood sample for roughly 100 proteins that the company has linked to the progression of diabetes, then produces a numerical score that quantifies an individual’s diabetic risk. People with scores at the low end of the spectrum will actually have a substantially lower risk of diabetes — as much as five times lower — than conventional measures might suggest, while those at the other end may face an equally elevated risk.

This is obviously a pretty big deal if the test works the way Tethys says it does. The company says it refined and validated its test over the past five years — it was founded in 2002 — using tens of thousands of historical blood samples and matching them against whether the donors actually developed diabetes. Tethys says it’s already presented supporting data at various scientific meetings over the past year, although it doesn’t appear to have actually published any of it yet.

Tethys isn’t saying exactly which proteins it’s identified for the test, although the company’s CEO, Mickey Urdea, acknowledged that some are indicators of glucose metabolism, while others are related to liver function, inflammation and blood coagulation.

“This is why using a single marker, or a combination of two markers, has always been insufficient” to make accurate diabetes-risk predictions, Tethys chief scientific officer Mike Richey says. “There are multiple pathways by which people reach [a diabetic state of] glucose dysregulation.”

What, exactly, could a high-scoring individual do to alter his or her fate? Obviously, the first step would be to start paying closer attention to diet — specifically to the consumption of sugary or refined-carbohydrate foods that tend to trigger repeated surges of insulin production in the body — and to exercise more. In addition, Tethys officials suggest that some of the safer diabetes medications now in use, particularly the generic drug metformin and newer drugs such known as DPP-IV inhibitors such as Merck’s Januvia, might be able to prevent irreversible damage well before it occurs.

Diabetes PreDx is the result of years of stealthy work by a group of former employees at Chiron’s diagnostic unit, who came together at Tethys to find a way to make useful blood tests that could help patients and their doctors postpone or prevent the onset of serious chronic diseases. The company is also at work on a predictive test for osteoporosis, and has another diagnostic candidate in the pipeline. Tethys hasn’t said what it will charge for Diabetes PreDx, but says its models show that identifying and, presumably, postponing the onset of diabetes in a single individual can save the healthcare system $1,100. So don’t expect the test to be particularly cheap.

Tethys also just raised an undisclosed sum in a third round of funding, bringing its total financing so far to $54 million. Investors in the round included Intel Capital, Kleiner Perkins Caufield & Byers and Mohr Davidow Ventures.