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
But he doesn't just notice the desperate need; he sees a way to
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
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
"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. …