Breast
FDA Approves VIAS(TM) to Aid Clinical Assessment of Breast Cancer
By TriPath Imaging Inc. (Nasdaq: TPTH) and Ventana Medical Systems Inc.
Aug 18, 2005, 11:27

TriPath Imaging Inc. (Nasdaq: TPTH) and Ventana Medical Systems Inc. (Nasdaq: VMSI), announced today that TriPath Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for the Ventana Image Analysis System (VIAS(TM)) when used with tissues stained for HER-2/neu. In May 2005, the companies announced 510(k) clearance for VIAS when used with the Ventana Estrogen (ER) and Progesterone (PR) Receptor assays.

"FDA clearance for the analysis of HER-2/neu clearly increases the utility of VIAS as an aid to the clinical assessment of breast cancer," said Paul R. Sohmer, M.D., chairman, president and CEO of TriPath Imaging. "We expect to continue to further expand the application menu supported by VIAS with additional 510(k) applications."

"We are pleased that TriPath Imaging has obtained this clearance," stated Christopher Gleeson, president and chief executive officer of Ventana Medical Systems. "This expands our VIAS menu and, together with the previous clearance for ER/PR, enables us to provide further value to pathologists."

HER-2/neu protein analysis aids in the management of breast cancer patients and is used by physicians to aid in prognosis and prediction of therapy outcomes for breast cancer.

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