CLX to initiate validation study for Zonda’s Chlamydia test

Safis Solutions is currently interviewing virology laboratories as candidates to conduct the study, which is expected to begin shortly. The purpose of the study is to perfect the testing protocol in preparation for the clinical trials as part of the process to achieve FDA clearance for the product.

In addition to their use in preparation for the clinical trials, results from the validation study may be helpful in other applications, such as in overseas markets where additional clinical data can support the sales of the products currently in the market. CLX may also pursue a strategic alliance relationship with an established company in the US medical diagnostic testing market to provide resources and assistance through the clinical trials and FDA clearance application process, and the validation study may help to secure such a relationship.

Vera Leonard, CEO of Zonda and CLX, said: “The market potential of Zonda’s rapid point of care test for chlamydia, assuming it receives FDA clearance and CLIA waiver, is so significant that we want to make certain that all of our procedures are conducted correctly.”