- Corgenix Receives Regulatory Approval for Sale of AspirinWorks® in China
Product News: Corgenix Receives Regulatory Approval for Sale of AspirinWorks® in ChinaCorgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, has announced that the Company’s AspirinWorks® ELISA product has received notification of regulatory approval from the State Food and Drug Administration (SFDA) of the Peoples Republic of China. The approval enables Corgenix to begin commercialization of the AspirinWorks diagnostic test kit in China, one of the world’s largest and fastest growing medical markets.
“Securing SFDA approval in China for diagnostic products is an extensive process, and in some ways more rigorous than securing clearance in the U.S.,” said Douglass Simpson, President and CEO of Corgenix. “As part of Corgenix’ corporate strategy to expand our global presence with our proprietary products and technologies, establishing this presence in China is a major accomplishment, providing us ready access to a very large and growing market.”
In conjunction with its international distribution partner, The ELITech Group, Corgenix will begin selling the AspirinWorks product through Beijing Ningjiang Technology And Trade Co., Ltd., a prominent Beijing-based medical device distribution company. Corgenix Medical and Beijing Ningjiang are considering ways to further expand the relationship to include other diagnostic products and opportunities, and will be collaborating in clinical studies in major medical institutions in China.
“We expect that this agreement will boost our revenues by an additional three to five percent this fiscal year,” continued Simpson. “That would be an outstanding accomplishment for first-year product sales goals, and we foresee potentially much greater levels over the next few years. There is tremendous growth potential in China, and Corgenix is prepared to serve the upcoming explosive demand for this testing, seizing any chance to become a key player in this promising market.”
AspirinWorks is the only U.S. FDA-cleared test that measures the urinary biomarker 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals post ingestion. 11dhTxB2 is a metabolite of thromboxane A2 (TxA2), the target of aspirin therapy. The test targets a potential global market exceeding 200 million individuals.
Unlike functional platelet tests, which require freshly drawn blood that must be evaluated within at least four hours, the AspirinWorks Test is performed on a random urine sample that can be obtained in any doctor’s office or clinic.