Digene Diagnostics Inc. announced Thursday that it hasreceived a $600,000 contract from the National Cancer Instituteto run diagnostic assays for human papilloma virus (HPV) onpap smears from more than 21,000 women.

The effort is part of NCI's attempt to determine the relativerisks of cervical cancer in women infected with HPV.

"The study is to test the correlation between the level of thevirus and the disease," Evan Jones, president and chiefexecutive officer of Digene told BioWorld. "Strong data alreadyexists to indicate that there is one.

"NCI is interested in improved methods for cervical cancertesting," he said. "The agency feels that viral testing is the waveof the future, and this study is to confirm that so it can beadopted into clinical practice."

The Silver Spring, Md., company's Hybrid Capture test, whichuses DNA probe technology, "allows rapid, simple probeassays," Jones said. The chemiluminescent assay uses anantibody to recognize the structure of nucleic acid hybridsformed in the reaction. Detection is by "classical immunoassaymethods," Jones said. "It takes about three hours to run andgives quantitative results."

The assay's quantitative abilities offer an advantage for HPVtesting because "the level of virus in a cervical specimenindicates whether a woman has a cervical lesion," Jones said.

Privately held Digene manufactures the only FDA-approvedtest for HPV, which detects DNA probe hybridizations viaradioactive dot blots. The Hybrid Capture product is intendedas a replacement, Jones said. -- Jennifer Van Brunt

(c) 1997 American Health Consultants. All rights reserved.

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