FDA Clears A Hazelwood Manufactured Test For Toxoplasmosis Infections In People

The U.S. Food and Drug Administration (FDA)  approved the first test to help pinpoint the date of infection for toxoplasmosis in people, specifically pregnant women, and it's created here in the .

The VIDAS TOXO IgG Avidity  is the name of the assay. An assay is defined as procedure in molecular biology for testing or measuring the death rate of a drug or biochemical in an organism. It is manufactured by bioMérieux Inc. The FDA cleared the Hazelwood based company's production of the product on May 18.

“Toxoplasmosis can have serious and lasting health consequences for infants that acquire the infection in the womb,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health, in a press release. “This test gives doctors an additional tool to determine if women with confirmed cases of toxoplasmosis acquired the infection before or during pregnancy.”

Toxoplasmosis is caused by the Toxoplasma gondii parasite. It is often associated with cats, but many other species can serve as hosts.

Veterinarians are thought to be professionals at greater risk of exposure, according to the Centers For Disease Control and Prevention (CDC), but the FDA cleared this first test is intended to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis, developed the infection within the past four months.

Common symptoms of toxoplasmosis include swollen lymph nodes and flu-like symptoms. The infection can cause serious health problems in people with compromised immune systems, according to the FDA.

Toxoplasmosis is considered to be a leading cause of death attributed to foodborne illness in the United States, according to the CDC. The parasite can be transmitted to people who eat raw, undercooked or contaminated meat or come in contact with infected cat feces or litter, according to FDA.

The CDC states that more than 60 million men, women, and children in the U.S. carry the Toxoplasma parasite, but very few have symptoms because the immune system usually keeps the parasite from causing illness. Because toxoplasmosis is associated with impoverished people it is considered a Neglected Infection of Poverty, which the CDC defines as parasitic, bacterial and viral infections that disproportionately affect impoverished people in the United States.