Abbott Receives FDA Approval for First Fully Automated Blood Test for 'Kissing Bug' Disease

ABBOTT PARK, Ill., May 19 /PRNewswire-FirstCall/ -- Abbott received Biologic License Application (BLA) approval from the United States Food and Drug Administration (FDA) for the ABBOTT PRISM Chagas test. The test is a fully automated blood screening assay that can detect antibodies to Trypansoma cruzi (T. cruzi), a parasite found only in the Americas and most commonly acquired through contact with the blood-sucking triatomine or "kissing bug." According to the Centers for Disease Control and Prevention, an estimated eight to 11 million people are infected worldwide with Chagas disease and an additional 108.6 million people are considered to be at risk. If left undiagnosed and untreated, Chagas disease can result in death.

In 2007, national screening of the blood supply for the disease was instituted. The FDA reports that in the last three years more than 1,000 donors with Chagas disease were identified.

This latest approval for the ABBOTT PRISM analyzer marks the completion of Abbott's full menu of blood screening tests, which includes assays for hepatitis, HIV and other retroviruses. Most recently, the ABBOTT PRISM HIV O Plus test was added to the analyzer's menu of available assays. ABBOTT PRISM systems can screen 160 blood donations per hour, making it possible to test more than 1,200 donations in an eight-hour laboratory shift. Speed and efficiency are important to labs, given that the Department of Health and Human Services reports that more than 16 million units of blood are collected in the United States each year. Used by more than 30 countries, the ABBOTT PRISM system is used to screen the majority of the blood supply in the United States and around the world.

"The approval of the ABBOTT PRISM Chagas test marks the availability of an important automated tool to ensure the continued safety of our blood supply, and it also offers our customers the ability to conduct all their serology testing on one system to increase the productivity and efficiency of their labs," said John Coulter, divisional vice president, U.S. commercial operations, Abbott Diagnostics.

Important Product Usage and Safety Information

The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi), the causative agent of Chagas disease, in human serum and plasma specimens. The ABBOTT PRISM Chagas assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components and other living donors, for the presence of antibodies to T. cruzi. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non–heart-beating) donors. It is not intended for use on cord blood specimens or for the laboratory diagnosis of Chagas infection. This assay has not been validated for use with plasmapheresis specimens, amniotic fluid, cerebrospinal fluid, pleural fluid or pooled specimens. This product contains human sourced and/or potentially infectious components.

About Chagas Disease

Chagas disease is caused by the parasite T. cruzi, which is transmitted to animals and people by insects through contact with the feces of an infected triatomine bug. Infection also occurs congenitally, through transfusions of contaminated blood products, or through an organ transplant from an infected donor. If left untreated, Chagas disease develops from an acute to a chronic illness, which could result in constipation, digestive problems, abdomen pain, and abnormal heart rhythms or heart failure, which may result in death. As many as 11 million people are infected by the disease, which is endemic throughout much of Mexico, Central America, and South America.

About Neglected Diseases

Chagas disease belongs to a group of 13 tropical diseases (NTDs), considered neglected as they disproportionately affect the world's poor and marginalized populations, and tend to fall low on the list of public health priorities. According to the World Health Organization (WHO), more than one billion people or one-sixth of the world's population suffer from one or more neglected tropical diseases. Important progress towards the elimination and eradication of neglected tropical diseases is being made as a result of the development of public-private partnerships, drug donations from pharmaceutical companies, increased country and international agency commitment, and effective intervention strategies. Abbott is committed to the development and modification of new drugs and diagnostic tools to address unmet needs in the area of neglected disease prevention, diagnosis, treatment and management.

About Abbott Diagnostics

Abbott Diagnostics is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements, including the development of the very first diagnostic test to detect HIV.

About Abbott

Abbott (NYSE: ABT) 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 approximately 83,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

SOURCE Abbott