ANSWERS
04/01/1996

<TITLE> FDA APPROVES FIRST BLOOD TEST FOR BREAST CANCER RECURRENCE </TITLE>
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T96-22                                  Sharon Snider
April 1, 1996                           (301) 443-3285

   FDA APPROVES FIRST BLOOD TEST FOR BREAST CANCER RECURRENCE
     We have been receiving calls about an FDA approval of the
first blood test to help determine whether a woman's breast
cancer has returned.
       The following can be used to answer questions:
     The test measures CA 27.29, a tumor marker similar to CA 15-
3 antigen, found in the blood of patients with breast cancer and
certain other types of cancer.  As breast cancer progresses, the
level of  CA 27.29 antigen in the blood rises.  In clinical
studies, the new test accurately detected the breast cancer
antigen in 60 percent of women who had a recurrence.
     Currently recurrence is monitored through such procedures as
mammography, magnetic resonance imaging and x-ray.
     The new test gives doctors an additional tool to help detect
recurrence of breast cancer in the earliest stages.  It is not
intended as the sole basis for a diagnosis of cancer, which can
only be made after the test results are verified by other
procedures.
     The test is carried out on a blood sample by using the
Truquant BR Radioimmunoassay (RIA) test kit made by Biomira 
                             -More-                                  Page 2, T96-22, Breast Cancer
Diagnostics, Inc., of Rexdale, Ontario, and the results can be  
analyzed in a few hours at a hospital laboratory.  
     FDA's decision to approve the test was based on a review of
safety and effectiveness data submitted by the manufacturer and
on the recommendation of the Immunology Devices Panel of FDA's
Medical Devices Advisory Committee.
     Biomira used the test on blood specimens from 166 women who
had previously had breast cancer in clinical studies at five
sites in the United States.  The women were also evaluated with
radiographic procedures.  The test found the cancer antigen in 15
of 26 women (60 percent) who had a recurrence.  It also indicated
cancer in eight of 140 patients who did not have it.
     Because the test did not detect the cancer antigen in all
cases and detected it falsely in some, FDA based its approval on
use of the test in conjunction with other procedures to monitor
recurrence of Stage II or Stage III breast cancer. 
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