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Diagnostics FDA

 News Release - December 13, 2006

Ortho-Clinical Diagnostics Receives FDA Approval for First Blood-Screening Test for Chagas' Disease

New Data Report Increase in U.S. Blood Donors Testing Positive for Exposure to Chagas' Disease

RARITAN, N.J., Dec. 13 (HSMN NewsFeed) -- Ortho-Clinical Diagnostics, a Johnson & Johnson company, announced today that the U.S. Food and Drug Administration (FDA) has licensed its new test designed to screen blood donations for exposure to Chagas' disease -- a tropical, parasitic disease that originates in South America. Called the ORTHO® T.cruzi ELISA Test System, it is the first blood-screening test for Chagas' disease approved by the FDA for use in the United States.

"Data reported over the past decade indicate a strong upward trend in the proportion of U.S. blood donors testing positive for exposure to the parasite that can cause Chagas' disease," said Michael Waller, M.D., vice president, clinical and medical affairs, Ortho-Clinical Diagnostics. A study conducted in the same geographic area of the U.S. documents ratios of Chagas- seropositive blood donors ranging from one positive in 9,900 in 1996, to one in 7,200 in 1997, to one in 5,400 in 1998.(1) A new study, just completed in November of this year, documents the ratio of Chagas-seropositive blood donors at approximately one in 2,000.(2)

Also called American trypanosomiasis, Chagas' disease is an infection caused by the blood parasite Trypanosoma cruzi, or T.cruzi. The disease is endemic to most countries in Central and South America, as well as Mexico. Transmission occurs through insect bites, blood transfusions, organ transplants and via infected pregnant women to children in utero. Chagas' disease can damage heart tissue and can cause death. The Centers for Disease Control and Prevention (CDC) estimates that 16 to 18 million people worldwide are infected with Chagas' disease; of those, 50,000 will die each year. Chagas' disease can be treated successfully if detected soon after the infection occurs, but there is no cure once the disease has entered the chronic stage.

"This new test will help prevent transmission of Chagas' disease through blood transfusions," said Richard H. Carmona, M.D., M.P.H., FACS, 17th Surgeon General of the United States. "This case demonstrates our public health system at its best. The FDA, noticing an increase in the incidence of Chagas' disease, called upon the diagnostics industry to develop a reliable blood- screening test for use in blood banks nationwide. Working together, a remarkable solution is being implemented to safeguard the health and safety of the American people."

Today in the United States, more than 15 million units of blood are donated each year. Approximately 38,000 pints of blood are used every day in various medical procedures. Blood donations are currently screened for hepatitis, HIV and HTLV (Human T-lymphotropic virus). In December 2005, the FDA approved a blood-screening test for West Nile virus; in 2003, it approved a general diagnostic test for West Nile.

"Ensuring the safety of the blood supply is a major public health priority, and one that our company is proud to play a role in," said Cliff Holland, worldwide president, Ortho-Clinical Diagnostics. "As this test is implemented in blood banks nationwide, we can reduce the risk of transmission of Chagas' disease through blood transfusions."

In clinical trials, the ORTHO® T.cruzi ELISA Test System demonstrated 100 percent sensitivity to all geographic strains tested of Chagas' disease, and demonstrated an observed specificity of 99.99 percent. The test qualitatively detects T.cruzi antibody in human serum and plasma. The test, fully automated on the Ortho Summit(TM) System, will be used to screen blood donations for the presence of antibodies that develop in response to exposure to the parasite that can cause Chagas' disease. Ortho-Clinical Diagnostics will immediately launch the ORTHO® T.cruzi ELISA Test System and has sufficient production capacity to meet the needs of blood banks nationwide.

To date, there have been 12 confirmed cases of Chagas' disease transmission in the U.S. and Canada.(3) No estimates exist for the total number of people infected with the disease now living in the U.S. In July, in a Centers for Disease Control report about two recently confirmed transmissions of Chagas' disease via organ transplants, researchers said: "The prevalence of infection with T.cruzi in the U.S. varies by region and might now be higher than previously thought, especially in geographic regions such as Los Angeles County, where a substantial proportion of blood and organ donors have emigrated from Chagas-endemic countries."

Blood screening is an effective approach to preventing the transmission of Chagas' disease via blood transfusions. As noted in the August 24th edition of The New England Journal of Medicine, screening blood donations for Chagas' disease has contributed to a significant decline in transmissions of this deadly disease in countries contending with this public health problem.(4)

In 2007, Ortho-Clinical Diagnostics will seek FDA approval to expand use of its test for Chagas' disease in tissue and cell transplants (cadaveric testing) and for general diagnostic purposes.

Physicians and patients with questions about Chagas' disease are encouraged to visit the CDC's Web site at

About The Ortho Summit(TM) System

The Ortho Summit(TM) System fully automates the processing of blood donation screening assays. The automated features of the instruments and compliance-driven software ensure stringent test standards are met and all critical functions are monitored, controlled and documented to achieve the highest quality standards and safety of the blood supply.

About Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world's blood supply. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions and services that promote effective diagnoses and enhance patient care. For more information, visit

(1) Leiby, et al, Transfusion, 2002; 42: 549-555

(2) Dr. Susan L. Stramer, Executive Scientific Officer, American Red Cross; presentation at 2006 American Association of Blood Banks (AABB) "Ongoing Clinical Evaluations of a Chagas' ELISA in US Blood Donors; Trypanosoma cruzi Antibody Prevalence in Three Regions of the American Red Cross" 23 October 2006

(3) To date in the United States and Canada, there have been seven cases via transfusions (Source: Leiby et al, Trypanosoma cruzi in Los Angeles and Miami blood donors: impact of evolving donor demographics on seroprevalence and implications for transfusion transmission. Transfusion. 2002 May; 42(5):549-55.) and five cases via organ transplants (Chagas Disease After Organ Transplantation --- Los Angeles, California, 2006 , MMWR July 28, 2006 / 55(29);798-800, and additionally, Chagas Disease After Organ Transplantation --- United States, 2001, MMWR, March 15, 2002 / 51(10);210-2)

(4) Chagas' Disease - Can We Stop the Deaths? by James H. Maguire, M.D., M.P.H., The New England Journal of Medicine, Vol. 255, No. 8, August 24, 2006

Source: Ortho-Clinical Diagnostics

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