NEWS
05/15/1993

<TITLE>FDA Clears quick, New Laboratory test for Chlamydia</TITLE>
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P93-25                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Sharon Snider (301) 443-3285


     The Food and Drug Administration today cleared a quick, new
laboratory test for chlamydia, a sexually transmitted disease that
affects four million people annually in the United States.
     The new test can detect chlamydia cases that otherwise might
be missed by the conventional culture method of testing for the
disease.  The test can be carried out on male urine or with a swab
sample of the cervix or urethra.
     Made by Roche Molecular Systems Inc. of Branchburg, N.J., the
test will be marketed as the Amplicor Chlamydia Trachomatis Test.
     Chlamydia genital tract infections are common in sexually
active teenagers and young adults.  Men are the primary carriers,
but may not show symptoms.  These men may transmit chlamydia to
their partners.  If left untreated, these infections can cause
sterility, infertility and other problems, including pelvic
inflammatory disease, endometriosis, ectopic pregnancy and
respiratory and eye infections in babies of infected mothers.
     "Detecting and treating chlamydia promptly can have an
enormous effect on preventing future reproductive problems in young
women," said FDA Commissioner David A. Kessler, M.D.   "Since this
test can be used more reliably than the culture method with a man's
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urine specimen, it may encourage more men to be tested and prevent 
their passing the infection on to their partners."
     Detecting  chlamydia in men has been difficult.  Current urine
tests are not always reliable, and procedures for taking swab
samples from the urethra are uncomfortable.
      This test is the first commercial use of a new scientific
tool that makes it possible to quickly copy the genetic material of
chlamydia.  Testing can be completed in about four hours, compared
to three to seven days for the conventional cell culture method.
     FDA's decision to clear the test for marketing was based on
the agency's review of clinical studies in which 2,689 patients
were tested at five medical centers using both the new test and the
cell culture method. On men, the tests used urine and urethral swab
specimens.  On women, swab specimens from inside the cervix were
used.
     The studies showed that the new test was better than the
culture method in detecting the infection in both men and women--
significantly better in men.
     On male urine, the new test had 95 percent sensitivity in
detecting infection compared with 68 percent sensitivity for the
culture method.  On urethral specimens, the test had 91 percent
sensitivity in detecting infection compared with 83 percent for
culture.  And on cervical specimens, it had 94 percent sensitivity
overall compared with 86 percent for culture.  However, the test
also missed some cases of chlamydia that were detected by the 
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conventional method.
     FDA is one of eight Public Health Service agencies in the
Department of Health and Human Services.
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