In a unanimous vote, the FDA Advisory Panel forMicrobiological Devices has recommended approval of the testsystem for analyzing human papilloma virus (HPV) developedby Oncor Inc. The recommendation, which was reached lastweek, is conditional on specified changes in labeling.
"With an incidence of greater than 1 million cases diagnosedper year, HPV is the most common of the viral sexuallytransmitted diseases, and is associated with an increased riskof cervical cancer," said George Evanega, president and chiefoperating officer of Oncor (NASDAQ:ONCR).
Oncor's HPV analysis kit uses a Southern blot nucleic acidhybridization assay for detecting and distinguishing betweenHPV types 6, 11, 16, 18, 31, 33 and 35 in exfoliating cells of theuterine cervix.
The test developed by Oncor of Gaithersburg, Md., is designedto complement existing methods for detecting cervical disease.
(c) 1997 American Health Consultants. All rights reserved.