PALO ALTO, Calif., May 9, 2013 /PRNewswire/ -- CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced its onsite clinical laboratory has received accreditation from the College of American Pathologists (CAP), which is awarded to facilities that meet the highest standards of excellence in quality laboratory practices. This recognition adds to the certification of the clinical laboratory previously received from the Centers for Medicare and Medicaid Services' (CMS) Clinical Laboratory Improvements Amendment (CLIA) and to the licensure issued by the New York State Department of Health. CardioDx offers Corus® CAD, the only clinically validated gene expression blood test for evaluating patients with signs and symptoms suggestive of obstructive coronary artery disease (CAD), nationally through its accredited laboratory in Palo Alto, CA.
The CAP Laboratory Accreditation Program is an internationally recognized program and the only one of its kind to utilize teams of practicing laboratory professionals as inspectors. During the accreditation process, inspectors examine the clinical laboratory's records and quality control procedures, as well as the laboratory's equipment, facilities, safety program and overall laboratory management to ensure it meets CAP's stringent requirements. The goal of the CAP program is to improve patient safety by advancing the quality of pathology and laboratory services through education and rigorous standards, which meet or exceed regulatory requirements. CMS has granted the CAP Laboratory Accreditation Program deeming authority. The program is also recognized by the Joint Commission, and can be used to meet many state certification requirements.
"CardioDx is proud to join an outstanding group of more than 7,300 laboratories worldwide that have received CAP accreditation," said David Levison, President and CEO of CardioDx. "This important milestone reflects our commitment to providing the highest quality standards for our clinicians and their patients."
About Obstructive Coronary Artery Disease
Coronary artery disease is a very common heart condition in the United States. One in five deaths among Americans is caused by CAD.1 CAD can cause a narrowing or blockage of the coronary arteries (vessels to the heart that supply the heart with blood, oxygen, and nutrients), reducing blood flow to the heart muscle. This narrowing or blockage in the coronary arteries is often referred to as obstructive CAD, characterized by the presence of atherosclerosis or plaque.
About Corus CAD
With a simple blood draw, Corus CAD can safely, accurately and conveniently help primary care clinicians and cardiologists assess whether or not a stable non-diabetic patient's symptoms are due to obstructive coronary artery disease, enabling many patients to avoid unnecessary invasive procedures and exposure to imaging-related radiation risks or imaging agent intolerance. The test has been clinically validated in multiple independent patient cohorts, including two prospective, multicenter U.S. studies, PREDICT and COMPASS. Additionally, a retrospective, multicenter chart review study and the prospective IMPACT trial at Vanderbilt University demonstrated that Corus CAD use yields statistically significant and clinically relevant changes in patient management decisions in both primary care and cardiology settings. The test has been used commercially by clinicians in more than 38,000 patients and is a covered benefit for more than 40 million Medicare enrollees in the U.S. Corus CAD is the only test for CAD that is sex specific and accounts for key biological differences between men and women.
Corus CAD has also been recognized by The Wall Street Journal's Technology Innovation Awards, honored as a Gold Edison Award recipient, and named one of TIME's Top Ten Medical Breakthroughs. CardioDx was recently honored as one of FierceMedicalDevices' "Fierce 15" most promising privately held medical device and diagnostic companies.
The Corus CAD test is intended for use in non-diabetic stable patients who present with typical or atypical symptoms suggestive of CAD, with no known history of CAD, no prior myocardial infarction (MI) or revascularization procedure, and who are not currently taking steroids, immunosuppressive agents or chemotherapeutic agents.
CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, is committed to developing clinically validated tests that empower clinicians to better tailor care to each individual patient. Strategically focused on coronary artery disease, cardiac arrhythmia and heart failure, CardioDx is poised to expand patient access and improve healthcare quality and efficiency through the commercialization of genomic technologies. For more information, please visit www.cardiodx.com.
This press release may contain forward-looking statements, including statements regarding the business strategy of CardioDx, the safety and efficacy, adoption rate and size of the market for Corus CAD, and beliefs regarding the need for and value of gene expression diagnostics. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These statements reflect the views of CardioDx as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
About the College of American Pathologists
As the leading organization for board-certified pathologists, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. With more than 18,000 physician members, the CAP has led as the gold standard in laboratory accreditation for 50 years with more than 7,300 CAP-accredited laboratories in 50 countries. Find more information about the CAP at www.cap.org.
1 Lloyd-Jones D, Adams R, Carnethon M, et al. Heart Disease and Stroke Statistics--2009 Update: A Report From the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009;119:480–486.
SOURCE CardioDx, Inc.