started selling its test by studying blood samples from people who were followed for years, and teased out differences in protein markers in the blood of those who got diabetes versus those who didn’t. [Correction 9 am Eastern: An earlier version said the Tethys test had won FDA approval. It hasn’t. The test is sold through a CLIA-certified lab]. That’s one form of data, but Tethys is looking to prove the value of its test with a much deeper body of evidence, Richey says. The company is looking at whether its test can actually change patients’ behaviors around food and exercise, whether it can convince physicians to incorporate more preventive medicine into their practices, and whether this predictive test will actually end up saving the healthcare system a lot of money by containing the consequences of diabetes.
If Tethys is successful, it will enlist more partners to its cause. The Big Pharma companies want to sell more of their diabetes treatments, of course, and would like a test to help them target their marketing to patients who need drug therapy. Big commercial labs might be interested in contracts to perform “high-volume, high-value” tests like PreDx, Richey says. Over time, Tethys sees itself branching out from its base in diabetes to other predictive blood tests, like for heart attacks or osteoporosis.
One potential snag that leapt out me was the cost of the diabetes test, which is probably too high for people to get repeated tests to track their progress over time. It also draws more than a pinprick of blood, so it’s not all that practical for repeated analysis. There have been instances in which patients have gotten follow-up tests to see whether their diet and exercise has lowered their risk of diabetes, although from what I gathered from Richey, most patients are get one test and then measure their progress in other ways, like how much weight they lose, blood pressure decreases, etc.
Still, as mentioned before, there are a lot of people out there to test for diabetes and not very many have had their blood analyzed by Tethys yet. The company sees itself very much in the early days, establishing a new market, starting with early adopters. There’s no major competitor, but the company has to make a clear, compelling argument before physicians and payers will get on the bandwagon. It is following some of the lessons described by Geoffrey Moore of Mohr Davidow Ventures, author of books about disruptive innovation like “Crossing the Chasm,” about making the transition with a new technology from early adopters to more mainstream acceptance.
“We’re on the left side of the chasm, and we plan on getting to the right side,” Richey says. “We’re going to do it with high quality clinical trials.”
