ANSWERS
10/03/1995

<TITLE> FDA APPROVES NEW PAP SMEAR SCREENING SYSTEM </TITLE>
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T95-55                                             Sharon Snider
Oct. 3, 1995                                       (301) 443-3285


           FDA APPROVES NEW PAP SMEAR SCREENING SYSTEM

     The Food and Drug Administration has approved a new device to
select Pap smears for re-reading.  Pap smears are tests that detect
cancer and precancerous cell changes in the cervix.
     The following can be used to answer questions.
     The product, the first of its kind to be approved, can be used
by laboratories as a quality control tool to re-screen all normal
pap smears in order to detect cervical cancer more reliably.
     Currently, cytotechnologists scan slides containing cervical
cells under a microscope to look for signs of abnormalities.  Ten
percent of all negative smears are routinely re-screened.  However,
even with this quality control feature, abnormal pap smears may go
undetected.  The error rate for Pap smears varies from lab to lab
but is estimated to be  5 percent to 25 percent.
     The new system, which employs image processing and pattern
recognition techniques, re-screens all Pap smears initially found
to be normal by the cytotechnologist and picks out the most
suspicious for a second review by the cytotechnologist.  Use of the
device increases the number of abnormal slides identified in the
Pap smear reading process.
                             -more-

                                    Page 2, T95-55, Pap Smear

     FDA's decision to approve the product--the Autopap 300 QC 
Automatic Pap Screener System, made by Neopath Inc. of Redmond,
Wash.--was based on a review of clinical studies on safety and
effectiveness submitted by the manufacturer and on the
recommendation of the Hematology and Pathology Devices panel of the
agency's Medical Devices Advisory Committee.
     Using the system, the firm re-screened ll,751 Pap smears
previously found to be normal at seven clinical laboratories in the
United States.  Of those, 297 or 2.5 percent were found to be
abnormal.
     Although the new system detects more abnormal Pap smears than
does the current method, it does not eliminate all false negatives. 
False negatives may still occur as a result of reading errors,
sampling and technical errors in handling the smears or by a
rapidly progressing cancer that cannot be identified during routine
screening.
     The Autopap was approved Sept. 29, 1995.  A similar product,
Papnet,  made by Neuromedical Systems of Suffern, N.Y., is also
under review by the agency.
     Some 50 million Pap smears are done annually in the United
States.  
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