MURRIETA, Calif. CLX Investment announced that Safis Solutions is preparing to begin clinical trials for Zonda’s test for Chlamydia, in an effort to achieve clearance from the Food and Drug Administration for the product. CLX has controlling ownership of Zonda.
Safis has been sought as a sub-contractor of American Health Partners who had been engaged by CLX to assist with the launching of medical diagnostic testing products for CLX’s subsidiaries. As part of preparation for the trials, Safis has sent out bid requests to several contract research organizations to conduct the studies for Zonda.
Safis has begun work on the testing protocol and will submit it to the FDA before testing begins. Safis has developed estimates on the number of expected clinical sites and the anticipated timeframe necessary to gather data. Once the clinical data is completed, the data will be analyzed and Safis Solutions will prepare and submit documents for FDA clearance, which will allow for its sale in the United States.
In 2006, 1,030,911 chlamydial infections were reported to Centers for Disease Control from 50 states and the District of Columbia. This is the first time in history that reported cases of Chlamydia in the U.S. have exceeded 1 million. Zonda's rapid point-of-care test will be the first of its kind for the STD.