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In Brief: Digene

This article was originally published in The Gray Sheet

Executive Summary

Digene: Submits premarket approval application supplement to FDA for its Hybrid Capture II human papillomavirus DNA test. The test is a next generation to the firm's Hybrid Capture test, permitting "simultaneous testing of multiple samples from a single 96-well microtiter plate." When used in conjunction with Pap smear testing, the Hybrid Capture II test can detect 95-100% of high grade lesions and "virtually all instances of cervical cancer," Digene claims. The Beltsville, Maryland firm plans to develop the test's format to allow simultaneous testing of HPV, chlamydia and gonorrhea from a single patient specimen, and it expects to submit 510(k)s to FDA for tests for those diseases in 1998...
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