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Precise Low-Dose Drug Monitoring Essential for Long-Term Kidney Transplant Success

Study Highlights Performance of Abbott's ARCHITECT Tacrolimus Assay, Only Automated Transplant Monitoring Test that Meets International Standards for

Low-Level Monitoring

WASHINGTON, July 30 /PRNewswire-FirstCall/ -- The ability of blood tests to precisely measure very low doses of anti-rejection drugs in kidney transplant patients may make a significant difference in assuring long-term viability and survival, according to research presented today at the American Association for Clinical Chemistry (AACC) annual meeting.

The current thinking in transplant medicine favors reducing doses of tacrolimus and other immune-suppressive drugs as much as possible after kidney-transplant procedures. "Even though we are succeeding in preventing organ rejection, we haven't made much progress to improve long-term survival," said Sudarshan Hebbar, M.D., senior medical director, Abbott Diagnostics. "Unfortunately, most kidney transplant patients will go back on dialysis in eight to ten years, in part because the anti-rejection drugs can be toxic to the kidneys."

Dr. Hebbar added that kidney-transplant patients have high incidence of heart attacks and other cardiovascular disorders from long-term effects of renal disease. Therefore, minimizing drug toxicity over time is considered one way to help improve long-term graft survival and preserve quality of life for transplant patients.

To minimize long-term toxicity of transplant medications, physicians frequently aim to taper down doses of immunosuppressive drugs to as low a level as possible without risking rejection. "Successful low-dose regimens of tacrolimus and other anti-rejection medications require highly precise, ultra-sensitive drug-monitoring assays," said Daniel Levine, Ph.D., director of the clinical laboratory, Iris and B. Gerald Cantor Clinical Research Laboratory at The Rogosin Institute in New York City.

Dr. Levine emphasized the importance of using an accurate and precise test to monitor patients on low-dose treatment regimens. "At low doses, even the slightest variation in blood-level readings could be devastating to transplant patients. The consequence for the laboratory is twofold: it must have accurate, precise testing for immunosuppressive drugs, and tacrolimus tests that are accurate to 4 ng/mL are no longer adequate," he explained.

Dr. Levine reported results of his studies evaluating the performance of the Abbott ARCHITECT assay for tacrolimus, the most widely used immunosuppressant drug. He said the usual dosing range for the medication is between 2 and 15 ng/mL, with lower doses preferred. "The challenge for the laboratory, therefore, is to assure with the utmost confidence to the physician that a tacrolimus blood level of 3 ng/mL is exactly right and not 5," Levine said.

In the trials, the Abbott ARCHITECT tacrolimus assay was accurate and precise at low levels and showed consistent results. "The functional sensitivity in our hands was 0.9 ng/mL, exceeding the package insert claim of 2 ng/mL. We are fully confident the ARCHITECT tacrolimus assay meets our requirement for low-level tacrolimus monitoring," Levine said.

"The ARCHITECT tacrolimus assay is the only automated transplant monitoring test that meets international standards for low-level monitoring," according to Dr. Hebbar.

The ARCHITECT tacrolimus assay is used for the quantitative determination of tacrolimus in human whole blood, as an aid in managing liver and kidney transplant patients receiving tacrolimus therapy.

About the ARCHITECT Family

With its extensive menu of diagnostic tests, user-friendly software and advanced sample management capabilities, the ARCHITECT family and the currently marketed flagship analyzer, ARCHITECT(R) ci8200(R), meet the needs of today's diagnostics laboratory by enhancing workflow and productivity. ARCHITECT instruments are designed with laboratory-focused features such as the capability to prioritize emergency tests, the ability to use common reagents among platforms and sample monitoring. These features not only minimize training, but also reduce inventory costs and sample contamination potential, leading to better results for laboratories, physicians and, ultimately, patients.

About Abbott's Diagnostics Businesses

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 65,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs. Abbott's history is filled with examples of first-of-a-kind diagnostic products and significant technological and research advancements.

About Abbott

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 68,000 people and markets its products in more than 130 countries.

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