Gen-Probe, a year-old San Diego biotechnology firm, said Monday that it is ready to market a DNA diagnostic test that detects the 22 species of bacteria that cause legionnaire's disease, a rare type of pneumonia.
The test is the first DNA probe--a manufactured strand of nucleic acid--cleared by the U.S. Food and Drug Administration for clinical diagnostic use, said Chairman Thomas Adams, adding: "There are a lot of people in this business, but we think we're now the leader."
Although other tests for legionnaire's disease are available, Gen-Probe's is the only one able to identify all 22 bacterial species, Adams said. An estimated 25,000 to 50,000 cases of legionnaire's disease are diagnosed annually in the United States, Adams said. Proper treatment is not possible without an accurate diagnosis. When left untreated, the disease is fatal in 10% to 15% of its victims.
Gen-Probe's test, which uses the patient's saliva with the DNA testing material, takes two to four days. A refined version expected to be introduced later this year will cut that to just two hours, the company said.
Gen-Probe is entering a market worth several million dollars, Adams said. The company is developing two more products that will diagnose lower respiratory tract infections that are common causes of pneumonia, Adams said. Those products will eventually be sold to doctors and hospitals, Adams said.
The company is "in the process of setting up a direct marketing and sales operation," Adams said. The legionnaire's disease test will be used by hospitals and commercial clinics.