A news release regarding CYTYC:
REDMOND, WASH. (Nov. 8) BUSINESS WIRE -Nov. 8, 1996--NeoPath, Inc.
(NASDAQ:NPTH) and Cytyc Corporation (NASDAQ:CYTC) today announced that
the companies had completed a joint study to investigate the feasibility
of screening cervical specimens using NeoPath's AutoPap System and
Cytyc's ThinPrep System.
The pilot study demonstrated that the AutoPap properly segmented 100% of
the ThinPrep slides containing high-grade cervical abnormalities into
the set to be subsequently examined microscopically by
cytotechnologists. The AutoPap System also properly segmented 95.7% of
the slides containing low-grade abnormalities. NeoPath and Cytyc said
that the study illustrated the feasibility of combining the technologies
and that further development and testing was warranted.
"We are encouraged with the results of this early trial," said Dr. Alan
Nelson, President and CEO of NeoPath. "The AutoPap instrument was not
retrained to analyze the ThinPrep slides for this feasibility study, but
used its algorithms for conventional Pap smears. Through additional
algorithm training, it may be possible to further increase the
sensitivity of the AutoPap System for ThinPrep prepared specimens."
"Our focus is on commercializing our ThinPrep Pap Test as a more
effective method of screening women for cervical cancer," said Patrick
Sullivan, President and CEO of Cytyc. "We view automated interpretation
of our ThinPrep slides as complementary and as an advancement in women's
health care." Earlier this week, the U.S. Food and Drug Administration
(FDA) approved Cytyc's claim that the ThinPrep Pap Test is
"significantly more effective" than the conventional Pap smear.
A total of 252 ThinPrep prepared slides were included in the feasibility
study. The AutoPap System was operated in a primary screening mode to
sort out the 116 slides that contained predetermined cervical
abnormalities. With the AutoPap set at a primary screening sort rate of
30% no review, the sensitivity to high-grade slides was 100%, and the
sensitivity to low-grade slides was 95.7%. These results were presented
this week at the National Conference of the American Society of
Cytopathology in Denver.
The AutoPap System is a medical device that integrates proprietary
high-speed image processing computers, video imaging technology and
sophisticated image interpretation software to capture and analyze the
thousands of microscopic images from any slide specimen. The FDA
granted NeoPath approval to market the AutoPap 300 QC System on
September 29, 1995. In March 1996 NeoPath received HCFA approval for
the AutoPap System to be used in the federally mandated quality control
rescreening of conventional Pap smear slides.
The AutoPap System rescreens Pap smear slides initially classified as
"normal" by cytotechnologists. Clinical trials showed the device
improves the detection rate of "false negatives" up to five-fold in
conventional Pap smear testing in U.S. clinical laboratories, thus
increasing the ability to identify early signs of cervical cancer.
NeoPath, Inc., developed the AutoPap System in pursuit of its goal to
help eradicate cervical cancer worldwide. The company's core expertise
is in the research, development, and commercialization of technologies
to automate the interpretation of medical images. NeoPath's
headquarters is located in Redmond, Washington.
Cytyc Corporation develops, manufacture and markets the ThinPrep System
for medical diagnostic applications. The ThinPrep System consists of
the ThinPrep 2000 Processor and related reagents, filters and other
supplies. Currently over 400 laboratories in the U.S. utilize the
ThinPrep 2000 for use in diagnosis of cancers including cancers of the
cervix, lung, bladder, and gastrointestinal tract and in the preparation
of fine needle aspiration of thyroid and breast. Cytyc's headquarters,
research, development, and manufacturing facilities are located in
Boxborough, Massachusetts. |
