Digene Diagnostics Inc. of Silver Spring, Md., has received Foodand Drug Administration approval to market its ViraTypeHuman Papillomavirus (HPV) DNA Typing Kit, a post-pap smeardiagnostic, the company said Friday.
Approximately 40 million pap smears are performed annuallyin the United States to identify women with pre-cancerouslesions. Between 2 percent and 5 percent of these tests yieldpositive or equivocal results. It is this group that will becandidates for Digene's test, said Attila Lorincz, vice presidentof research at Digene.
Lorincz said ViraType makes it possible for the first time toassess the differential risk of developing cervical cancer basedon HPV DNA type. Women who have HPV type 16 or 18 are asmuch as 15 times more likely to develop dysplasia, a pre-malignant condition of the cervix, than HPV-negative women.In addition, women with HPV type 16, 18, 31, 33 or 35 have agreater risk of contracting cancer than those with other HPVtypes.
Worldwide, nearly 500,000 women develop cancer of thecervix each year. Approximately 50 percent of women withcervical cancer die within 2.5 years of diagnosis. In the UnitedStates, 13,500 new cases are diagnosed annually and 6,000women die of the disease.
ViraType Test Kits, priced at $449, provide tests for 25 women.Based on these figures, the potential U.S. market for the kits isbetween $14 million and $36 million.
ViraType will go on the market in mid-1991. The kit has beensold for research purposes since 1988, said Lorincz.
Oncor Inc., of Gaithersburg, Md., is Digene's closest competitorfor HPV kits. Oncor is developing an HPV typing kit using theSouthern Blot test. Oncor sells the kit for research purposes andapplied last fall for FDA marketing approval. Oncor's kits sellfor $750 for a 60-patient kit and $350 for a 20-patient kit. --Karen Bernstein
(c) 1997 American Health Consultants. All rights reserved.