Acupath Soon to Offer "Flaer" Reagent for Diagnosing PNH

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New Diagnostic Process Identifies Rare Blood Disease More Accurately and Allows for Quicker Treatment

Acupath Laboratories Inc. has announced it will soon offer flow cytometry testing using the FLAER reagent for paroxysmal nocturnal hemoglobinuria (PNH), an acquired genetic blood disorder. The disease is defined by hemolysis, in which the body's own immune system destroys its red blood cells. Once approved from the New York State Department of Health to offer the test, expected early summer of 2009, Acupath will become one of the few labs in the tri-state area to use the new FLAER reagent for the diagnosis of PNH, along with the traditional CD55 and CD59 antibody staining.

The fluorescent version of the protein aerolysin, FLAER selectively binds to specific protein anchors on the surface of the red and white blood cells. In testing at the National Institutes of Health, FLAER has been shown to more accurately and more specifically identify PNH clones. The absence of FLAER binding on two different cell types (e.g. on red blood cells and on granulocytes) define the presence of a PNH positive clone. Most importantly, by using FLAER, smaller clone sizes can be recognized leading to earlier diagnosis.

"While PNH is an extremely rare disorder," says Zsuzsanna Vegh-Goyarts, Ph.D., co-director of flow cytometry and tumor markers for Acupath Laboratories, a leader in hematological pathology, "we do get requests from physicians for this test. We felt it was important for our hematology department to make PNH testing and the new FLAER reagent available to our current clients as well as new ones, especially since very few private labs locally offer this test."

Dr. Vegh-Goyarts explained that PNH affects 8,000-10,000 people in North America and Europe, typically striking men and women in their early 30s. "It develops without warning and, because it is so rare, PNH often goes unrecognized, with delays in diagnosis ranging from one to more than 10 years. PNH patients tend to survive 10-15 years from the time they are diagnosed," she says.

PNH is a progressive disease that causes thrombosis (clotting) in various body systems; end organ damage to the brain, lungs, liver, kidneys and gastrointestinal systems; severe anemia, disabling fatigue, recurrent pain, and shortness of breath, kidney disease and episodes of dark-colored urine, among other symptoms.

Prior to the implementation of the FLAER reagent in 2000, physicians relied mostly on flow cytometry test using only CD55 and CD59 antibodies. "The FLAER molecule is the most reliable reagent to diagnose PNH and has as an added advantage. If combined with other antibodies, FLAER can help to identify other blood diseases including aplastic anemia, because of the increased specificity and sensitivity." Dr. Vegh-Goyarts says.

One reason that doctors are using newer, more accurate tests for PNH recently is the launch of a new drug therapy, Soliris, which was approved by the FDA in 2007 and is extremely effective at treating symptoms of PNH. The drug, from Alexion Pharmaceuticals, works by blocking the reaction that causes hemoplysis. Additional treatments may include bone marrow transplant, transfusions and steroids.

About Dr. Zsuzsanna Vegh-Goyarts: With ample experience in the field of tumor biology and immunology, Dr. Zsuzsanna Vegh-Goyarts, Ph.D. serves as the co-director of the flow cytometry and tumor markers department at Acupath Laboratories. Prior to Acupath, she was an assistant professor in immunology research at the State University of New York (SUNY) at Stony Brook and served as a consulting assistant director of flow cytometry at Enzo Clinical Laboratories, Inc. She spent her postdoctoral years in prestigious research institutes, including the Immunology Department of Albert Einstein College of Medicine, New York, and the Tumor Biology Department of the Karolinska Institute in Stockholm, Sweden. Dr. Vegh-Goyarts' research has appeared in an extensive list of peer reviewed publications in various scientific journals. She holds a Certificate of Qualification in Oncology-Sera and Soluble Tumor Markers, Diagnostic Immunology and all four areas of Cellular Immunology from the New York State Department of Health (NYSDOH). Dr. Vegh-Goyarts received her Ph.D. in Medical Science and Immunology in Budapest, Hungary.

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MELISSA CHEFEC
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