Corgenix Medical Corporation announced in collaboration with Randox Laboratories that Randox has been granted CE Mark notification for its TxBCardio Assay.
The TxBCardio test measures urinary levels of the thromboxane metabolite 11dhTxB2 to determine aspirin effect in apparently healthy individuals. CE mark designation enables commercial marketing and distribution of the product in Europe.
The TxBCardio automated immunoturbidimetric (IT) assay format enables testing for urinary 11dhTxB2, the thromboxane metabolite measured by the AspirinWorks Test (ELISA assay), to be run on clinical chemistry platforms for higher-volume laboratories and in hospitals. The AspirinWorks Test is a simple urine test that measures levels of 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals.
The AspirinWorks Test was FDA-cleared in the U.S. in 2007; the TxBCardio brand was established to better emphasize the importance of the thromboxane biomarker while expanding into new products and technologies. The AspirinWorks ELISA assay continues to be sold worldwide.
"Achieving CE Mark is a significant milestone in our collaborative development efforts with Randox for thromboxane testing," said Douglass Simpson, Corgenix President and CEO. "We’re also moving forward with our strategic partner and master distributor, the ELITech Group, to expand global coverage of this new assay and broaden application onto additional platforms."
The TxBCardio assay will be manufactured at Randox Laboratories in the United Kingdom. Both Corgenix Medical and Randox Laboratories will 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 and therefore is not cleared for clinical diagnostic use in the United States.