Abbott announced today that it has received approval from the United States Federal Food and Drug Administration for a new Chagas in vitro diagnostics test called ABBOTT enzyme strip assay (ESA).

Chagas, commonly found --but not limited to-- South and Central America, is a life-long disease transmitted with contact with the feces of an infected triatomine bug (also known as the “kissing bug”). Some uncommon ways it can spread is from pregnant mothers to unborn children and from contaminated blood and organ transfusions. The illness, primarily caused by the protozoan parasite Trypanosoma cruzi, occurs in two phases.

The first acute phase symptoms (if symptoms even occur at all) include: fever, eye swelling, or irritation/swelling at the site of the insect bite. After the acute phase, the disease goes into a dormant stage, where its symptoms do not show for years at a time. If left untreated, the chronic phase occurs. There are more severe symptoms associated with the chronic stage that can consist of: constipation, digestion difficulties, abdomenal pain, esophageal swelling, and heart failure.

According to the U.S. Centers for Disease Control and Prevention, more than 11 million people are affected around the globe, predominantly in poor rural populations. The number of people living in the United States infected with T. cruzi and at risk for developing Chagas disease is estimated to be 300,000 or more.

In 2007, the FDA created a mandate for blood donors to be screened, and since then, almost 1,500 infected people have been identified in four years. Currently, there are two donor screening tests licensed to detect antibodies for T. cruzi.

The first test ORTHO T. cruzi ELISA Test System was approved in 2006. The second test approved in 2010 was Abbott’s own Prism Chagas. ABBOTT ESA will be the first licensed supplemental test.

The in vitro supplemental blood test from Abbott, ABBOTT ESA, detects the antibodies in human serum and plasma samples made when Trypanosona cruzi is present in the body. The supplemental test uses a licenced screening test on human serum or plasma specimens found repeatedly reactive.

"Chagas disease can cause significant and debilitating symptoms for those infected," said John Coulter, Divisional Vice President, Diagnostics, Abbott. "The new ABBOTT ESA Chagas test provides organizations that screen blood with an approved testing method to help keep the blood supply safe and enable them to confidently counsel infected donors."

Another recent innovation in the treatment of Chagas occurred on November 07, 2011, when scientists from Murdoch University and Monash University developed a cure for the disease in mice. The research involved heavily altering the chemical composition of an agricultural fungicide to create a new drug that was non-toxic to mice who had their immune systems lowered; regardless of the drug’s efficacy.

The next step in treatment development involves carrying out clinical trials on humans; many researchers have hopes that these trials will begin within a year.

"There is clearly a desperate need for new, effective, non-toxic drugs to treat and cure these diseases,'' Thompson Murdoch, University Professor and Parasitologist, said.