Corgenix Announces Filing of 510(k) Premarket Notification for FDA Clearance of TxBCardio Assay
Corgenix Announces Filing of 510(k) Premarket Notification for FDA Clearance of TxBCardio™ Assay
Filing is first under Corgenix Medical - Randox Laboratories co-development agreement
DENVER, Dec. 16, 2013--(BUSINESS WIRE)--Corgenix Medical Corporation (OTC BB: CONX.OB) announced today that in collaboration with Randox Laboratories, the first premarket notification has been filed with the U.S. Food and Drug Administration pursuant to Section 510(k) of the U.S. Federal Food, Drug and Cosmetic Act for the TxBCardio™ immunoturbidimetric (IT) assay.
“Along with our strategic partner and master distributor, the ELITech Group, we intend to expand the application of this new assay onto additional platforms over the next 18-24 months.”
The Company stated that the TxBCardio brand was established to better emphasize the importance of the thromboxane biomarker while expanding into new products and technologies.
The filing is based on TxBCardio’s substantial equivalence to the Corgenix AspirinWorks ELISA assay, a simple urine test that is FDA cleared to measure levels of 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals. Co-development of the TxBCardio IT assay enables the 11dhTxB2 AspirinWorks assay to be run on clinical chemistry platforms for higher-volume laboratories and in hospitals.
“This 510(k) application marks a substantial step forward in our collaborative development efforts for thromboxane testing,” said Douglass Simpson, Corgenix President and CEO. “Along with our strategic partner and master distributor, the ELITech Group, we intend to expand the application of this new assay onto additional platforms over the next 18-24 months.”
The assay would be manufactured at Randox Laboratories in the United Kingdom. Both Corgenix Medical and Randox Laboratories would be selling the new test worldwide under the TxBCardio brand name.
The safety and efficacy of the TxBCardio assay has not yet been evaluated by the FDA.
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience in product submissions to the FDA and other worldwide regulatory authorities. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com.
Statements in this press release that are not strictly historical facts are “forward-looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.
Corgenix Medical Corp.
William Critchfield, 303-453-8903
Senior VP Operations and Finance and CFO
Armada Medical Marketing
Dan Snyders, 303-623-1190 x230
Vice President and Public Relations Supervisor
Posted: December 2013