Answers
08/29/1994

<TITLE>FDA APPROVES TEST FOR PROSTATE CANCER</TITLE>
<PRE>

P94-16                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Sharon Snider (301) 443-3285
Aug. 29, 1994                      Home (301) 622-0977

              FDA APPROVES TEST FOR PROSTATE CANCER

     The Food and Drug Administration today approved the first
blood test to help detect prostate cancer in men 50 and older.  The
test, a prostate specific-antigen (PSA) blood test, was approved
for use in conjunction with a digital rectal exam.
     The PSA test was initially approved by FDA in 1986 to aid in
the care of patients who already had been diagnosed with prostate
cancer.  Today's approval expands the use to include helping to
diagnose the disease.  
     The PSA test by itself cannot be relied on to determine
whether a man has prostate cancer.  It must be used in conjunction
with other diagnostic procedures, including the digital rectal
exam.  The final diagnosis requires a biopsy.
     "This test--used with other procedures--can help detect those
men at risk for prostate cancer early on when more treatment
options are available," said FDA Commissioner David A. Kessler,
M.D.  "But for the test to help, men must be aware of the
importance of early check ups and get them on a regular basis."
     FDA's approval of the test--the Tandem PSA Assay made by
Hybritech Corp. of San Diego--is based on a review of clinical
studies on safety and effectiveness submitted by the manufacturer 
and on the recommendation of FDA's Immunology Devices Panel.  The
tests were done in conjunction with a digital rectal exam.
                             -MORE-

                               Page 2, P94-16, Prostate Cancer Test
     The firm's studies of more than 6,300 men showed that PSA
testing when combined with a rectal exam was more effective in
detecting prostate cancer than either a rectal test or PSA test
alone.  
     While high levels of PSA may signal prostate cancer, they may
also signal other common, non-cancerous prostate disorders. 
Conversely, low PSA levels do not necessarily indicate an absence
of prostate cancer.  Therefore, it is important that the PSA test
be interpreted with results from other established procedures such
as a digital rectal exam.  If either test is positive, confirmatory
testing with transrectal ultrasound and biopsy is needed to
diagnose prostate cancer.
     Prostate cancer is the second most common cancer in men in the
United States, after skin cancer.  The prostate gland, which
produces seminal fluid, is about the size of a walnut and is
located below the bladder and in front of the rectum.
     Most cases of prostate cancer occur in men 65 or older, with
the risk increasing with age.  Approximately 13 percent of American
men will be diagnosed with the disease during their lifetimes, but
most cases never become life threatening.
     Many questions still remain in the medical community about how
best to treat prostate cancer.  To help answer these and other
questions, the National Cancer Institute is currently sponsoring a
long-term screening study of 37,000 men, ages 60 to 74.
     FDA is one of eight Public Health Service agencies in HHS.
</PRE>