New Study Highlights Importance Of Testing For Aspirin Effect With FDA-Cleared AspirinWorks® Test

By failing to address the most common causes of aspirin ineffectiveness, a small clinical study recently published online in the journal Circulation highlights the importance of clinically validated, FDA-cleared testing for aspirin effect with the AspirinWorks ® Test to help prevent heart attack and stroke.

In the Grosser, et al. study, University of Pennsylvania researchers looking at 400 healthy volunteers and the impact of enteric coated versus uncoated aspirin, narrowly focused on a rare, genetic resistance to the effect of taking aspirin and ignored the far more common causes limiting the effectiveness of aspirin.

Millions of Americans take a daily aspirin to reduce or prevent cardiovascular events. Aspirin works on blood platelets to decrease levels of thromboxane, the chemical in the body that makes platelets sticky. Lower thromboxane levels and decreased platelet stickiness means less chance of developing a blood clot and therefore, less chance of a heart attack or stroke. The AspirinWorks Test from Corgenix Medical Corp (OTC BB: CONX), which was not included in the study, is not intended to measure or diagnose what the study refers to as “genetic aspirin resistance,” and is in fact the only U.S. FDA-cleared test that measures the urinary biomarker 11-dehydro thromboxane B2 (11dTxB2) to determine aspirin effect.

“The study’s severe limitations, including the fact that it had absolutely nothing to do with our company’s AspirinWorks Test for aspirin effect, actually highlights the importance of screening patients who are taking aspirin,” said Corgenix President and CEO Douglass Simpson. “Doctors test patients because despite taking aspirin, their levels of the inflammatory chemical thromboxane could still be dangerously high, not just because they might have some rare genetic disorder.”

Despite the confusing reports about the Grosser et al trial, Simpson said the bottom line is that people taking a daily aspirin with continued high levels of thromboxane are at a clinically proven increased risk of heart attack or stroke compared to patients without elevated levels.

“While we strongly believe ignoring non-genetic causes of aspirin ineffectiveness is misleading, this study gives us the opportunity to further educate the medical community and the public they serve about the critical importance of testing for aspirin effect and understanding how it impacts risk,” continued Simpson.

Simpson emphasized that while so-called “genetic aspirin resistance” as defined in the study is rare, failure of patients to respond to the intended beneficial effect of aspirin is absolutely not rare. There are many roads that lead to aspirin effect or the lack thereof, putting patients at increased risk of heart attack and stroke. Reasons for the inability of aspirin to do its job include:
  • Diseases and other inflammatory processes that produce chemicals (thromboxane) that can reduce aspirin’s beneficial effect
  • Other medications that interfere with the intended anti-clotting effect of aspirin
  • Unusually high levels of stress
  • Genetically poor responders to aspirin therapy

The AspirinWorks Test identifies those individuals who have elevated thromboxane levels despite taking a daily aspirin dose, with studies showing up to 25 percent of individuals not seeing the expected beneficial effects of aspirin. Corgenix stated that their test has been clinically validated through extensive research and numerous well-designed and well-powered clinical trials. The AspirinWorks/11dhTxB2 Test is FDA-cleared and used by thousands of physicians to test and guide treatment for hundreds of thousands of patients each year worldwide.

“Our test tells physicians whether or not the aspirin their patients are taking is providing the adequate level of protection they expect,” said Simpson. “It remains the only product clinically validated to do so.”

About the AspirinWorks Test

Launched in the U.S. in June 2007 following FDA 510(k) clearance, the AspirinWorks Test is available nationwide through major medical laboratories. 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 patient service center, making the test convenient for both physician and patient. More information is also available at www.aspirinworks.com .

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders, including the world’s only non-blood-based test for aspirin effect. 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. Such statements, which are inherently uncertain, are based on management’s current expectations and are subject to various factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such 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 reports filed with the Securities and Exchange Commission, and in the Company’s subsequent 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 or intend to publicly update or revise any forward-looking statements.

Copyright Business Wire 2010

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