Oncor gets additional export approvals:
This article was originally published in Clinica
The US FDA has given Oncor (US) permission to export its investigational IVD genetic test systems for HER-2/neu and Chronic Myelogenous Leukaemia Mbcrlabl to Austria, Switzerland and Ireland. This follows export approvals granted earlier this year (see Clinica No 661, p 17). Oncor expects its HER-2/neu (ERBB2) gene amplification detection system for breast cancer to be reviewed by a US FDA panel in the final quarter this year. A PMA application was filed for the test in February 1994.