PANEL SAYS MORE DATA NEEDED FOR BIOCONTROL'SDIASENSOR
By Jim Shrine
Biocontrol Technology Inc. wanted to conduct additional tests of itsnoninvasive glucose sensor before taking it to an FDA panel, butwasn't able to before being rebuffed Monday by members of theClinical Chemistry and Clinical Toxicology Devices panel.
The panel failed to recommend clearance of the Diasensor 1000, adevice that uses infrared light and a sensor to measure glucose levels.Panel members said the test was not effective enough to meritclearance.
Panelists were shown data from a study of 23 diabetics who eachused the Diasensor for a month. The device worked better than 50percent of the time on only eight of the 23 patients.
Susan Taylor, director of public relations for Biocontrol, said resultsavailable at the meeting came from two-year-old data on a researchmodel.
"During that time we've been able to make it work better," Taylorsaid. "We had requested to do additional field tests with the currentproduction model before going to panel. The results that came backwould have been even better."
Taylor said the Indiana, Pa.-based company planned to conduct astudy of the improved Diasensor by putting the device in the homesof 20 diabetics. The company still wants to do that study but will holdoff until hearing back from the FDA regarding the panel'srecommendation, she said.
Biocontrol CEO Fred Cooper, in a prepared statement, said thecompany remains committed to bringing the glucose sensor to marketand is confident clearance will be gained. "While this follow-up datais obtained, Biocontrol will increase efforts to internationally marketthe Diasensor 1000," he said.
Taylor said Biocontrol recently opened an office in London andthrough it has begun taking orders for product shipments in 1996.
Regulatory procedures for devices such as the Diasensor are morelenient in Europe, but it wasn't clear what Biocontrol's strategy wasoverseas in light of the negative FDA panel recommendation.
Biocontrol's stock (NASDAQ:BICO) lost 41 percent of its value, or$1.69, Monday to close at 2.44. It gained 25 cents back Tuesday intrading of 5.7 million shares. n
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