I don't recall a discussion on this NRI don't recall a discussion about this NR from Abbott on October 20th. Perhaps I missed it. Were there any comments, then? now? Is this a lab machine instrument rather than a POC instrument. How would RAMP complement, supplement if Abbott was a partner? Appologies if I've missed the discussion.
ABBOTT ANNOUNCES THE WORLDWIDE LAUNCH OF AXSYM® TROPONIN-I ADV TEST THAT AIDS IN HEART ATTACK DETECTION
—TEST OFFERS ENHANCED PERFORMANCE AND STANDARDIZED RESULTS TO BETTER MEET EVOLVING STANDARDS OF PATIENT CARE—
Abbott Park, Illinois, October 20, 2004 – Abbott announced today the worldwide launch of AxSYM® Troponin-I ADV, which provides initial results within 15 minutes and offers improved detection of cardiac troponin—a protein that is released from dying heart muscle cells deprived of blood flow during a heart attack. By offering diagnostics tests that assist in determining a patient's overall cardiac health, Abbott's AxSYM® automated immunoassay instrument system provides one of the most comprehensive cardiac menus for the acute care hospital laboratory. Abbott plans to introduce and distribute the AxSYM Troponin-I ADV assay worldwide, replacing the current AxSYM Troponin test.
"Abbott really took a systematic approach to the design of AxSYM Troponin-I ADV," said Alan Wu, Ph.D., chief of clinical chemistry, San Francisco General Hospital and Professor of Laboratory Medicine, University of California at San Francisco, San Francisco, California. "The AxSYM Troponin-I ADV assay offers enhanced performance and greater stability. This assay is standardized to the new National Institute of Standards and Technology (NIST) Standard Reference Material developed in cooperation with an American Association of Clinical Chemistry (AACC) subcommittee. The test, when used in combination with other diagnostic modalities, provides physicians with the information they need to make critical and timely treatment decisions."
Assay standardization is one way to provide physicians with more comparable test results making it easier to interpret results across medical institutions using different test methods.
"Part of an acute cardiac diagnostic menu, doctors consider troponin assays to be one of the most important tests to use when diagnosing heart attacks," said William Brown, Ph.D., vice president, Diagnostic Assays and Systems Development, Abbott. "When developing the AxSYM Troponin-I ADV test, it was important to provide not only an accurate and sensitive test but also one that offered standardized results to better meet today's evolving standards of care. Abbott is one of the first manufacturers to offer this standardization with both ARCHITECT® and AxSYM troponin assays."
In early September, Abbott received 510(k) clearance for the AxSYM Troponin-I ADV test from the U.S. Food and Drug Administration (FDA).
The AxSYM immunoassay system can process up to 80 to 120 tests per hour allowing high to medium-volume clinical laboratories to process a variety of immunodiagnostic tests simultaneously. Other tests on AxSYM's cardiac menu include: AxSYM® BNP, AxSYM® CK-MB and AxSYM® Myoglobin. A metabolic assay, AxSYM® Homocysteine, is often ordered in conjunction with other tests to assess cardiovascular risk.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.