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Oncor receives FDA "approvable" letter for HPV analysis system; Digene goes public.

This article was originally published in The Gray Sheet

Executive Summary

ONCOR HPV ANALYSIS SYSTEM PMA IS APPROVABLE subject to "standard final labeling and routine FDA inspection requirements," the Gaithersburg, Maryland-based firm says. Oncor reported May 20 that it has received a letter from FDA indicating that the agency has completed its review of the premarket approval application and will approve the test once the conditions are met.
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