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Digene amends PMA (premarket approval application) for cervical cancer test:

This article was originally published in Clinica

Executive Summary

Digene has filed an amended premarket application supplement (PMAS) to extend the use of its Capture 2 HPV DNA test as a primary screening tool for cervical cancer and its precursors in conjunction with the Pap test for women aged 30 and over. The FDA, in March this year, deemed the PMAS not approvable for this indication and requested additional data and analyses from Digene. Evan Jones, Digene's chairman and CEO, said that the amendment addresses the FDA concerns.

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