New test for Lyme disease not being used?

Published: Friday, February 15, 2008,theledger.com

Local Lab's Discovery Waits for Buyers


LAKE ALFRED | A struggling laboratory here is learning it may require more than building a better mousetrap to get the world beating a path to its door.

After developing an improved diagnostic test for Lyme disease, Central Florida Research Inc. in Lake Alfred is still waiting for a crowd at its doorstep.

"These last seven months, nobody in this business has gotten paid," said Tom Long, 55, the lab's executive director. "The revenue has been just enough to cover our expenses."

The staff has shrunk from eight people to three in the past year, Long said. He hopes the new diagnostic tool, called a "Lyme Antigen Test," will make Central Florida Research profitable.

The lab staff developed the antigen test under the direction of its medical director, Clifford Threlkeld, a pathologist and also lab director for the Heart of Florida Regional Medical Center in Davenport. Central Florida Research has applied for a patent, which it hopes to get in 2009.

"I do think it will be successful," Threlkeld said. "It's not the be-all-to-end-all, but it definitely adds to what's out there."

Lyme is a bacterial disease most commonly spread through the bite of a deer tick. In its early stages, the disease causes flu-like symptoms, including fever, fatigue and muscle or joint pain.

Left untreated, the bacteria can cause chronic problems in the heart and nervous system, including cardiac inflammation and paralysis. It can be fatal.

Because Lyme disease shares symptoms with other illnesses, it's very difficult to diagnose.

Even when doctors suspect a patient might have Lyme, the most widely used diagnostic tool, a blood test called a "Western blot," is accurate less than half the time, said Nick Harris, the owner of IGeneX Labs in Palo Alto, Calif., the leading U.S. lab for Western blot screening.

That high rate of "false negatives" - people who test negative despite having the disease - also causes problems for Lyme sufferers, said Lori Hoerl of the Florida Lyme Advocacy Group in Jacksonville, who has the disease.

If a doctor later diagnoses Lyme disease, insurance companies will use a negative Western blot to deny paying for treatment, she said.

The Central Florida Research test represents an improvement because it detects the actual presence of the Lyme bacteria, said Pat Phillips, its lab director. The Western blot detects only antibodies, or substances the body produces in reaction to the bacteria.

The Lyme Antigen Test has proven to be about 90 percent accurate, Long said.

The lab finished development of the test a year ago, he said, but it took seven months to get state and federal licensing to perform it. Since then, Central Florida Research has been trying to spread the word among front-line doctors who treat the disease.

Besides word of mouth, the lab team has an information booth it has taken to medical conferences and seminars, such as a Jan. 19 event in St. Peterburg, he said.

Central Florida Research does about 10 to 20 tests a day, but it has the capacity to do 100 tests, Long said. It charges $250 per test, slightly higher than a typical lab fee.

The lab's Web site, www.centralfloridaresearch.com, also has helped market the test, he added. It's gotten referrals worldwide, including Chile, England, France and Germany.

From a personal standpoint, the results have been satisfying. A Winter Haven woman in her 30s had led an active, vibrant life until last year, when chronic fatigue forced her to drop out of graduate school, Long said. Previous tests were negative, but the antigen test showed she did have the Lyme bacteria.

"She's gotten her life back. She's back in graduate school," he said.

A 60-year-old woman from Chile also had been battling pain and fatigue for years but tested negative for Lyme, Long said. She's undergoing successful treatment after the antigen test proved positive.

Despite the state and federal certifications and the clinical results, Long, Hoerl and Threlkeld agreed Central Florida Research needs to gain the trust of the medical community before the test becomes widely accepted.

Long said he believes the small Lake Alfred lab can develop the same high regard enjoyed by Harris' IGeneX Labs.

"He's developed a reputation," Long added. "There's room in the marketplace for another company."

[ Kevin Bouffard can be reached at kevin.bouffard@theledger.com or at 863-802-7591. ]