TriPath Imaging, Inc.
Cancer-focused company submits PMA for HPV test of cervical samples to U.S. FDA
Published in Telemedicine Business Week, September 22nd, 2004
The new data are to include an out-of-vial option for testing for the presence of high risk HPV DNA with the Digene hc2 High-Risk HPV DNA Test, using the same specimen collected to prepare SurePath slides for cytological analysis.
In a supplemental filing to its premarket approval (PMA) for the SurePath liquid-based Pap test, TriPath Imaging submitted data from a prospective, paired sample clinical study designed to validate the testing of cervical specimens collected...
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