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BloodCenter of Wisconsin launches breakthrough FDA cleared leukemia test

Milwaukee – July 27, 2018

Milwaukee – July 27, 2018 – BloodCenter of Wisconsin’s Diagnostic Laboratories, part of Versiti, is the first to offer the Abbott RealTime IDH1 assay that identifies specific gene mutations in patients with acute myeloid leukemia (AML). BloodCenter’s new offering, which follows Abbott’s recent clearance from the U.S. Food and Drug Administration, has proven accuracy and sensitivity that helps to deliver more effective treatments for AML patients.

BloodCenter’s offering of the IDH1 Abbott RealTime PCR test is highly sensitive to detecting IDH1 genetic mutations found in patients’ blood and bone marrow samples. The assay has a detection rate of 98% (196/200) or greater at mutation levels of 1% and higher for all IDH1 mutations combined. Both this test and the IDH2 Abbott RealTime PCR test offer rapid test results in five to seven days. By offering both companion diagnostic tests, BloodCenter can help identify AML patients that could benefit from new treatments and the effective use of the targeted drugs TIBSOVO® (ivosidenib) and IDHIFA® (enasidenib).

According to the National Cancer Institute, more than 20,000 people will be diagnosed with AML this year and more than 10,000 patients will die due to the disease. Nearly 20 percent of AML patients have either IDH1 or IDH2 mutations that BloodCenter’s offerings will identify.

“This new test is an exciting addition to BloodCenter’s molecular oncology diagnostics portfolio. Through our collaboration with Abbott, we can continue to help provide better treatment options and outcomes for AML patients,” said Dr. Matthew Anderson, M.D., Ph.D., VP and medical director of the Diagnostic Laboratories at BloodCenter of Wisconsin. “Together, the IDH1 and IDH2 tests will help physicians to provide more customized treatment for AML patients and is another example of how BloodCenter is advancing precision medicine in our areas of expertise.”

About BloodCenter of Wisconsin 

BloodCenter of Wisconsin, part of Versiti, is a not-for-profit organization headquartered in Milwaukee, Wis., that specializes in blood services, esoteric diagnostic testing, organ, tissue and stem cell donation, medical services and leading-edge research. We advance patient care by delivering life-saving solutions grounded in unparalleled medical and scientific expertise. The collective efforts of Versiti affiliates result in improved patient outcomes, expanded access to care, and cost efficiencies for healthcare systems nationwide. For more information, visit versiti.org.


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