Digene works with FDA on HPV (Human Papilloma Virus) test, expects "yes" by 2003:
This article was originally published in Clinica
Apparently unfazed by the restrictive provisions attached to the US approval of its HPV DNA Pap test as a primary screen for cervical cancer, the Gaithersburg, Maryland company says it will supply more data, as requested by the FDA. It expects an unconditional approval for the product before the end of next year. Last month, the FDA's microbiology devices panel voted 6-2 in favour of approving the company's Hybrid Capture 2 High-Risk HPV DNA test, but with enough conditions to remove all the gloss from the decision.