General Biometrics Inc. announced Thursday that it hasreceived FDA approval to sell its two tests to detect Lymedisease and related disorders.
The San Diego company has been marketing the kits in Europeand for research use in the United States, so the tests areavailable immediately to clinical laboratories at a cost of $1 to$3.
Fred Adler, company general manager, said the U.S. market forthe tests is $10 million to $12 million, and $10 million inEurope.
The test uses a protein from the outer membrane of Borreliaburgdorferi bacteria. The protein was characterized by theNational Institutes of Health's Rocky Mountain Laboratories,which specialize in tick-borne diseases. General Biometrics haslicensed the technology from the NIH.
Like their relative that causes syphilis, borrelia organisms caninstigate a variety of chronic arthritic and neurologicsymptoms, often delayed in onset. Diagnosis of borreliadiseases has been hampered by the lack of specificity ofexisting methods. The company's two tests are more specific,and can distinguish Lyme disease from illness caused byrelated organisms, Adler said. -- Roberta Friedman, Ph.D.
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