By Mary Welch

When Vaughn Kirchhoff served in the Peace Corps in Brazil in the late 1960's and learned about Chagas' disease, little did he know that he had found his destiny.

"I kept an open mind [about a specialty] during medical school, but I remembered Chagas' and it fascinated me," he said. Eventually, he trained in infectious diseases and Chagas' at the National Institutes of Health.

Today, Kirchhoff is president of Goldfinch Diagnostics Inc., of Coralville, Iowa, a spinoff from the University of Iowa Technology Innovation Center on the Oakdale Research Campus. While overseeing the company, Kirchhoff maintains faculty and physician duties at the college and hospital.

Goldfinch is a biomedical research company using recombinant DNA to develop better diagnostic assays for infectious diseases. Its main focus is an improved test for Trypanosoma cruzi, a protozoan parasite that lives in the bloodstream. The parasite causes Chagas' disease, which is contracted from insects and wild animals.

More than 17 million people worldwide are infected, and about 45,000 die every year. Once infected, a person forever has the disease, which affects the heart in particular. Chagas' disease is particularly common in Central and South America and Mexico.

"The problem is that there are three tests that screen for Chagas' disease and they produce a lot of false-positive results," Kirchhoff said. "Think of the logistical problems of notifying these people they have the disease and telling them to go to their doctor and then finding out they are fine."

In Brazil, the largest blood bank screens 600 units a day. About 3 percent come up positive and the blood is thrown away at the San Paulo facility, Kirchhoff said. Of that 3 percent, about two-thirds are uninfected blood. "Two percent of all donations are thrown out," Kirchhoff said. "That's expensive and wasteful."

Screening Can Lead To 'Discrimination Problem'

In the U.S., blood banks do not screen for Chagas' disease, although the FDA recently created a survey asking questions about where a person lives or if a person grew up in poverty. Kirchhoff said the survey is another way of investigating.

"Because the disease is prevalent in Central and South America, [the FDA is] trying to find out if a person lived there," he said. "There is a discrimination problem with that, just as there was with Haitians and AIDS."

The possibility of Chagas' disease going undetected at blood banks is growing due to the increased numbers of Hispanics living in this country. About 9 million legal immigrants from Central and South America were admitted to this country from 1971 to 1994, Kirchhoff said. "That's not counting the millions of others who are illegal," he said.

In 1985, Kirchhoff screened the blood of 205 persons from Salvador and Nicaragua who lived in Washington, D.C. Of those, 10 were clearly infected.

About 13 million units of blood are donated annually in the U.S. Kirchhoff said if the test were done with any one of the devices currently on the market, a positive reading would be found in about 25 of out every 10,000 units. In other words, about 32,500 would test positive, but only about 1,300 would be infected with the virus.

Goldfinch Diagnostics is looking for specific antibodies for parasite antigens. "Infected people almost always have detectable levels of antibodies," Kirchhoff said.

Kirchhoff obtained $100,000 from the National Institutes of Health's Small Business Innovation Research (SBIR) grant program.

"We've been working on the immunoassay screening and we're very far along," he said. "We've certainly showed the feasibility of it and we're about to apply for a Phase II grant of $750,000. We've completed the specifics of the Phase I and I think we'll roar into Phase II."

Phase II studies will include testing as 10,000 people in the U.S. and Latin America. After that, Kirchhoff plans to apply for clearance with the FDA for clinical use but not for use in blood banks.

"It is very, very expensive to get the FDA to clear it for blood banks and it's a very complicated process," he said. "We're taking it one step at a time."

Usually, the Technology Innovation Center takes 75 percent of any profits as a result of its incubator program, with the scientist taking the rest. In this case, the university opted not to participate and Kirchhoff and his technical staff are splitting the profits 60-40.

"The board of regents looked at our invention and didn't want to invest the money into getting the patent," he said. "While there is a guaranteed market in Latin America, they didn't want to get involved in it. I think they made a reasonable decision."

Even though U.S. blood banks currently don't test for Chagas' disease, there is interest in Kirchhoff's work. He has been contacted by several potential manufacturing companies and has visited about half a dozen.

"I think with the data we'll get back from Phase II, it'll stimulate even more interest," he said. *

No Comments