Tethys Bioscience and the U.S. Air Force are collaborating to study the impact of the PreDx test in helping prevent Type 2 diabetes among the service's retirees and dependents. The simple-to-use, multimarker blood test is designed to determine an individual's risk of diabetes conversion within five years. The study will assess the correlation between receiving comprehensive and individualized information about disease risk and the motivation to adopt a healthier lifestyle. The test is performed using a routine fasting blood sample and quantifies a panel of biomarkers, resulting in the PreDx Diabetes Risk Score, according to the company's website.
The two-arm, randomized trial will enroll 600 pre-diabetic subjects at six Air Force bases in the U.S. All subjects will participate in a 12-week Group Lifestyle Balance Program. All subjects will be administered the PreDx DRS test at the beginning and end of the study period. Half of the study population will be given the results of their PreDx DRS test before they start the Group Lifestyle Balance Program and will know their specific risk profile; the other half will not see their results, according to a release.
"Our collaboration with the U.S. Air Force provides an optimal setting in which to prospectively demonstrate the value of PreDx DRS in enabling physicians and patients to determine what behavioral and dietary changes can be most effective in preempting disease in high risk individuals," Tethys Chairman and CEO Mickey Urdea explains in a statement. "With the CDC estimating as many as 79 million prediabetic people in the U.S., our medical system urgently needs better tools to stratify and identify the small percentage of those at most imminent risk who will benefit from intervention. PreDx DRS is that tool, and we look forward to the results of this important study."
According to Urdea, the whole area of risk identification for the prevention of diseases is about to explode, and Tethys happens to be at the right place at the right time. This particular collaboration came about after company representatives began talking with Air Force personnel at a conference, Urdea tells FierceMedicalDevices. The two parties saw the opportunity to collaborate, especially in light of the weight gain many former Air Force personnel experience right after leaving the service--as much as 30 lbs. in less than a year, Urdea points out.
Tethys has garnered the interest of a number of big-name backers, Urdea notes. Last summer, Tethys announced it had raised $33 million, including $23 million of venture financing and a $10 million working capital loan. Participants in the financing included new investors Greenspring Associates and Paul Capital Investments, as well as current investors. The working capital loan was provided by Oxford Finance Corporation and Silicon Valley Bank.
The company is selling its product in the U.S., and is not yet looking to expand to other markets. However, the company will look into the possibility of such an expansion at a later date, Urdea tells FMD. The company recently announced that sales of the PreDx DRS test have exceeded 35,000 units since it was commercially introduced in 2009.
- read the Tethys release
- and check out Xconomy's profile of the company from earlier this month