Oncor Receives FDA Approval to Export Genetic Test Systems Abroad

Strategic Insights -

Oncor, Inc. has announced that it has received permission from the U.S. Food and Drug Administration (FDA) to export its investigational in vitro diagnostic genetic test systems for HER-2/neu and Chronic Myelogenous Leukemia (CML) Mbcrlabl to the United Kingdom, Australia, and The Netherlands. This development comes after the completion of multi-center clinical investigations for the two test kits, which are currently undergoing review for pre-market approval at the FDA. The HER-2/neu Genetic Test System aims to aid physicians in predicting the likelihood of disease recurrence in women with breast cancer, while the CML Mbcrlabl test is being reviewed for use in diagnosing CML, one of the most common forms of adult leukemia.

Key Takeaways:

  • Oncor has received FDA permission to export its investigational genetic test systems for HER-2/neu and CML Mbcrlabl to the UK, Australia, and The Netherlands.
  • The two test kits completed multi-center clinical investigations and are currently undergoing review for pre-market approval at the FDA.
  • The HER-2/neu Genetic Test System is intended to aid physicians in predicting the likelihood of disease recurrence in women with breast cancer.
  • Over 180,000 women in the U.S. and 485,000 worldwide are diagnosed with breast cancer each year.
  • The CML Mbcrlabl test is being reviewed for use in diagnosing CML, one of the most common forms of adult leukemia.
  • Oncor develops, manufactures, and markets genetic test systems and related products for use in the detection and management of cancer and other human diseases.
  • Stephen Turner and Barbara Keech of Oncor are available for contact at 301-963-3500, while Diane Perry and Deanne Eagle can be reached at the Financial Relations Board's New York office, and Kathy Brunson is available in the Chicago office.

Statistics:

  • 180,000 women in the U.S. are diagnosed with breast cancer each year.
  • 485,000 women worldwide are diagnosed with breast cancer annually.
  • The number of breast cancer cases in the U.S. and globally is a significant public health concern.

Sources:

  • PRNewswire, June 27, 1995
  • Oncor, Inc.
  • U.S. Food and Drug Administration (FDA)