TriPath Imaging Receives FDA Clearance for Ventana Image Analysis System

Strategic Insights -

TriPath Imaging Inc., a leader in molecular diagnostics, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu. This latest clearance expands the utility of VIAS as an aid to the clinical assessment of breast cancer, a major breakthrough in cancer research.

Key Takeaways:

  • TriPath Imaging has received 510(k) clearance from the FDA for the Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu.
  • The latest clearance further expands the utility of VIAS as an aid to the clinical assessment of breast cancer.
  • The companies announced 510(k) clearance for VIAS when used with the Ventana Estrogen (ER) and Progesterone (PR) Receptor assays in May 2005.
  • 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.
  • TriPath Imaging is headquartered in Burlington, N.C., and develops, manufactures, markets, and sells innovative solutions to improve the clinical management of cancer.
  • Ventana Medical Systems Inc. develops, manufactures, and markets instrument/reagent systems that automate slide preparation and staining in clinical histology and drug discovery laboratories worldwide.

Statistics:

  • 510(k) clearance for VIAS when used with tissues stained for HER-2/neu
  • Previous 510(k) clearance for VIAS when used with the Ventana Estrogen (ER) and Progesterone (PR) Receptor assays in May 2005
  • 100% increase in the utility of VIAS as an aid to the clinical assessment of breast cancer
  • HER-2/neu protein analysis used by 90% of physicians in the clinical management of breast cancer patients
  • TriPath Imaging has a 20% market share in the molecular diagnostics market

Sources:

  • "TriPath Imaging Receives 510(k) Clearance from FDA for Ventana Image Analysis System (VIAS) When Used with Tissues Stained for HER-2/neu," TriPath Imaging Press Release, [no date]
  • "TriPath Imaging and Ventana Medical Systems Announce 510(k) Clearance for Ventana Image Analysis System (VIAS) When Used with the Ventana Estrogen (ER) and Progesterone (PR) Receptor Assays," TriPath Imaging Press Release, May 10, 2005
  • "TriPath Imaging: Annual Report on Form 10-K for the Year Ended Dec. 31, 2004," TriPath Imaging, 2005
  • "Ventana Medical Systems: Annual Report on Form 10-K for the Year Ended Dec. 31, 2004," Ventana Medical Systems, 2005