Biomira Receives Fda Expedited Review Status For Breast Cancer Diagnostic Blood Test Kit

Business Wire, April 20, 1995

EDMONTON, Alberta--(BUSINESS WIRE)--April 21, 1995--Biomira Inc. today announced that Biomira Diagnostics Inc., Toronto, its wholly-owned subsidiary, has been advised by the U.S. Food and Drug Administration (FDA) that the FDA has accepted as suitable for filing the Premarket Approval Application (PMA) of Biomira Diagnostics for its TRUQUANT(R) BR(TM) radioimmuno-assay (RIA) in vitro diagnostic blood test kit for recurrent breast cancer. The PMA filing is the culmination of a three-year prospective, multi-centre clinical trial testing the ability of the assay to detect recurrent breast cancer. The Company requested and received expedited review status for the PMA.

The FDA advised that the TRUQUANT(R) BR(TM) PMA was granted expedited review processing on the basis that accurate and reliable information about patient's disease status should be available to assist the clinician and that TRUQUANT(R) BR(TM) may offer significant advances in safety and effectiveness over other existing test modalities in the monitoring of previously treated breast cancer patients.

While the PMA was granted expedited review, such grant does not change the standards associated with obtaining FDA approval, which Biomira Diagnostics will have to satisfy, and does not imply that the FDA has performed an in-depth evaluation of the safety and effectiveness of TRUQUANT(R) BR(TM), nor does it imply that a decision of the approvability of the application has been made.

Biomira is a biotechnology company developing an integrated line of products for the diagnosis and treatment of cancer.

CONTACT: Biomira Inc.

Jane Jack, 403/490-2812