Norman Company Makes Cryptococcosis Test for Developing Countries
Wilkerson, April, THE JOURNAL RECORD
When Dr. Sean Bauman travels to developing countries that his company serves, it's far more than a courtesy visit.
He walks through the villages to see people suffering from AIDS, yet dying from a fungal infection that could be easily diagnosed and treated in America. He sees doctors' offices full of well- intentioned and caring clinicians who are strapped by a lack of electricity, refrigeration and an effective way to diagnose patients.
But he doesn't just notice the desperate need; he sees a way to meet it.
For 31 years, the Norman-based company IMMY (Immuno Mycologics Inc.) has produced fungal diagnostic products. On Tuesday, Bauman submitted for Food and Drug Administration approval a new product that stands to catapult the company to a new level and further his goal of helping people in developing countries. The product is a diagnostic test for cryptococcosis, an opportunistic fungal disease that is ravaging places like Sub-Saharan Africa and South Asia.
"It's the biggest thing to come out of IMMY, hands-down," said Bauman, president and CEO of the company his father started in 1979. "Our goal is simple: to change patient outcomes. If a person otherwise would have died because of this disease, we want to change that. If a person was hospitalized due to this disease and had a positive outcome, we want to remove the hospitalization portion. We're trying to push the diagnostic test as far down the health care chain as we can."
Cryptococcosis, like other fungal diseases, attacks people with compromised immune systems, and it hits particularly hard the developing countries where people are already hurting from HIV and AIDS, Bauman said. The mortality rate from cryptococcosis is 60 to 80 percent in some countries, and 650,000 people die from the disease annually in Sub-Saharan Africa alone, he said. However, the problem lies not in a lack of medication, but in a way to diagnose the disease.
Over the past decade, the pharmaceutical company Pfizer has donated $840 million in antifungal drugs to treat the disease. But the missing element is a sure way of diagnosing patients, Bauman said.
"The patients are truly sick, and you've got the therapy, but the missing piece is in the middle," he said.
That diagnostic test has been missing because of the challenges in creating it for places without the things Americans take for granted. In many developing countries, clinics and labs don't have consistent electricity, clean water, equipment or refrigeration, so they can't safely store or read today's diagnostic tests. IMMY's new product combines a simple diagnostic product with packaging and instructions that transcend language or setting.
The test is a dipstick, similar in technology to a pregnancy test. One drop of blood is enough to conduct the test, and one or two lines reveal a positive or negative result. The packaging and instructions are equally important, Bauman said.
"Current diagnostic tests require refrigeration, but that's not reliable there," he said. "You've also got high humidity there, which can affect tests, so we've got a lot of impervious packaging to make the test more reliable."
The World Health Organization sets forth criteria that such diagnostic tests must meet, Bauman said. The tests must be sensitive and specific, but they also must be affordable, he said. A similar fungal diagnostic test in America would cost between $5 and $25, an amount far out of reach for health care professionals in developing countries, he said. …