CLX Medical, Inc. Updates Process of Validation Study for Zonda’s Rapid Point of Care Test for Chlamydia
CLX Medical, Inc. (OTCBB: CLXN), which is focused on the launch and distribution of unique medical diagnostic testing products, today announced that the first stages of a pre-clinical trials validation study on Zonda Incorporated’s rapid point of care test for chlamydia have been initiated and that the testing itself is expected to commence once the required chlamydia cells have been grown and laboratory staff has been properly trained in the study procedures.
CLX currently holds a majority interest in Zonda, whose tests utilize proprietary technology that detects enzymes that are specific to the target microorganisms and are ideal for the clinical laboratory, point of care, and the over-the-counter (OTC) markets. Zonda’s chlamydia product has been distributed in Europe for approximately three years.
The validation study is designed to perfect the testing protocol in preparation for the clinical trials as part of the process to achieve FDA clearance for the product. With FDA clearance, CLX will seek to achieve widespread distribution for the HandiLab-C within the U.S., as well as broader distribution into worldwide markets.
IIT Research Institute (IITRI) (http://www.iitri.org) has been engaged to serve as the laboratory that will conduct a validation study. IIT Research Institute has provided non-clinical research and development services to the U.S. government and to sponsors in the pharmaceutical, biotechnology, chemical, agrichemical, and personal products industries for more than 40 years.
IITRI operates more than 125,000 square feet of state-of-the-art laboratory and support space in its Chicago facility.
“It is extremely important that a sound proof-of-concept and pre-clinical validation has been conducted prior to initiation of the clinical study, and we are pleased that the training and other preparations are currently underway,” stated Vera Leonard, chief executive officer of Zonda and CLX. “The testing itself will occur in a relatively short period, but the work leading up to it is critically important, both for the study and for the clinical trials expected to be initiated afterwards.”
“We look forward to receiving feedback from the validation study, which we expect to be completed by mid-June,” Ms. Leonard added.
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About CLX Medical, Inc.
CLX Medical, Inc. (www.clxinvestments.com) holds a 51% equity interest in Zonda, Inc., which has developed rapid point of care tests for medical and non-medical markets, and CLX recently announced a letter of intent to acquire another rapid diagnostic device for the medical market. CLX has also invested, and holds a common stock position, in ActionView International, Inc. (www.actionviewinternational.com), a publicly traded global manufacturer and marketer of “smart” scrolling advertising billboards.
All statements included in this release, including statements regarding potential future plans and objectives of CLX Medical, Inc. are forward-looking statements. Such statements are necessarily subject to risks and uncertainties, some of which are significant in scope and nature beyond CLX Medical’s control. There can be no assurance that such statements will prove accurate. Actual results and future events could differ materially from those anticipated in such statements depending on many factors. Historical results are not necessarily indicative of future performance.
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SOURCE: CLX Medical, Inc.