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New CHARISMA trial findings recently published in the American HeartAssociation's peer-reviewed medical journal Circulation confirm that elevatedurinary levels of the biomarker 11-dehydro thromboxane B2 (11dhTxB2) indicatean increased risk of heart attack, stroke and cardiac death.
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The AspirinWorks Test by Corgenix is the only FDA-cleared test thatmeasures urinary 11dhTxB2 to accurately determine the effect of aspirin inapparently healthy individuals. 11dhTxB2 is a metabolite of thromboxane A2,the target of aspirin therapy.
"The American Heart Association conference is an ideal forum in which todiscuss the findings on the relationship between elevated 11dhTxB2 levels andcardiovascular risk from the powerful and respected CHARISMA trial," saidGordon Ens, clinical director of Corgenix Medical Corporation. "Thiswell-designed, prospective outcome study demonstrates the potential value ofthe AspirinWorks Test for optimizing an individual's aspirin therapy."
CHARISMA is a multinational, multicenter, randomized, parallel group,double-blind trial involving 15,603 patients with either clinicallyestablished cardiovascular disease or multiple risk factors. The CHARISMAsub-study involved a total of 3,261 aspirin-treated patients from 224 sites in12 countries.
The AspirinWorks Test was launched in the U.S. in June 2007 following FDA510(k) clearance, and it is now available nationwide through major medicallaboratories as well as direct to consumers through HealthCheckUSA(http://www.HealthCheckUSA.com). The test targets a potential U.S. market ofover 60 million individuals and a potential global market exceeding 200million individuals who take aspirin for prevention.
Unlike functional platelet tests, which require freshly drawn blood thatmust be evaluated within at least four hours, the AspirinWorks Test onlyrequires a urine sample that can be obtained in any doctor's office or patientservice center, making the test convenient for both physician and patient.
Physicians and laboratories interested in ordering the test can call1-800-729-5661 x180, or e-mail: [email protected]. More information isalso available at http://www.aspirinworks.com.
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specializeddiagnostic kits for immunology disorders, vascular diseases and bone and jointdisorders, including the world's only non-blood-based test for aspirin effect.Corgenix diagnostic products are commercialized for use in clinicallaboratories throughout the world. The company currently sells over 50diagnostic products through a global distribution network and has significantexperience advancing products through the FDA process. More information isavailable at http://www.corgenix.com.
Statements in this press release that are not strictly historical factsare "forward looking" statements (identified by the words "believe","estimate", "project", "expect" or similar expressions) within the meaning ofthe Private Securities Litigation Reform Act of 1995. These statementsinherently involve risks and uncertainties that could cause actual results todiffer materially from the forward-looking statements. Factors that wouldcause or contribute to such differences include, but are not limited to,continued acceptance of the Company's products and services in themarketplace, competitive factors, changes in the regulatory environment, andother risks detailed in the Company's periodic report filings with theSecurities and Exchange Commission. The statements in this press release aremade as of today, based upon information currently known to management, andthe Company does not undertake any obligation to publicly update or revise anyforward-looking statements.
SOURCE Corgenix Medical Corporation
