Computer-Aided Detection in Screening Mammography Enhances Performance of a Single...

Computer-Aided Detection in Screening Mammography Enhances Performance of a
Single Reader
Large Scale, Historical Controlled Study Finds CAD Increases Sensitivity in
Cancer Detection with Only a Small Increase in Recall Rate

BEDFORD, Mass., Feb. 13 /PRNewswire-FirstCall/ -- Hologic, Inc.
(Nasdaq: HOLX), a diversified medical technologies company specializing in
imaging systems, diagnostics, and interventional devices dedicated to serving
the healthcare needs of women, today announced the publication of a large
scale breast screening trial comparing a single radiologist using computer-
aided detection (CAD) to double reading without CAD. The author of the study
is Dr. Matthew Gromet of the Breast Imaging Section of Charlotte Radiology, a
large imaging practice (approximately 66,000 screening mammograms a year) in
Charlotte, North Carolina. The study(1), published in the on-line version of
the American Journal of Roentgenology, the scientific journal of the American
Roentgen Ray Society, will appear in the April 2008 issue of the research
journal. The study compared the recall rate, sensitivity, positive predictive
value, and cancer detection rate for single reading with CAD, versus double
reading without CAD. Biopsy and pathology data for positive cases were also
compared.
Dr. Gromet found that a single reader with CAD had a statistically
significant increase in sensitivity (11%) and a smaller increase in recall
rate (4%), when compared a single reader without CAD assistance. He also found
that single reading with CAD review, when compared with independent double
reading, resulted in a not statistically significant increase in sensitivity
but with a statistically significant lower recall rate. With manpower
constraints limiting the use of double reading, Dr. Gromet concludes that "CAD
appears to be an effective alternative that provides similar, and potentially
greater, benefits."
The results were based on the performance of nine radiologists at
Charlotte Radiology with a mean level of experience in mammography of 15
years. The mammograms in the study were screen-film studies obtained on
Hologic mammography equipment. The CAD technology used in the study was the
Hologic R2 ImageChecker(R) CAD system. A total of 231,221 exams were included
in the study; 49% of the exams were double read without CAD and 51% were
single read with CAD.
"The Gromet study is a valuable addition to the body of knowledge on the
performance of radiologists reading screening mammograms with CAD assistance,"
says Ronald A. Castellino, MD, FACR, Chief Medical Officer for Hologic. "A
strength of this study is the large number of malignancies as well as the
large number of cases in both arms of the study (double reading without CAD
vs. single reading with CAD). The number of CAD cases is nearly four times
greater than that reported in the Fenton paper(2) published in the New England
Journal of Medicine last year. An additional strength is the use of data from
the same pool of experienced radiologists with considerable CAD experience."
A copy of this study may be found at:
http://www.ajronline.org/aheadofprint/04_07_2812_WI.pdf

Note on Sensitivity, Double Reading and CAD
The efficacy of screening mammography is enhanced when sensitivity is high
and the recall rate is low. Double reading, though used by few practices in
the United States, is a method for increasing sensitivity commonly used in
European screening programs. CAD has become increasingly popular as an
alternative way to increase sensitivity, since double reading is time-
consuming and because of a shortage of radiologists.
CAD has the potential to increase sensitivity of screening mammography by
marking areas of interest that might otherwise be overlooked by interpreting
radiologists. However, CAD also may place false marks, identifying areas of
suspicion that are not cancer. A small fraction of false marks may result in
unnecessary patient recalls for further evaluation. The major goal for CAD is
to reduce oversights when screening mammograms are read; the radiologist is
still responsible for lesion analysis and final interpretation of an
examination.
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium
diagnostics, medical imaging systems and surgical products dedicated to
serving the healthcare needs of women. Hologic's core business units are
focused on breast health, diagnostics, GYN surgical, and skeletal health.
Hologic provides a comprehensive suite of technologies with products for
mammography and breast biopsy, radiation treatment for early-stage breast
cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis
assessment, preterm birth risk assessment, and mini C-arm for extremity
imaging. For more information visit http://www.hologic.com.
Forward Looking Disclaimer
This News Release contains forward-looking information that involves risks
and uncertainties, including statements about the effect of the use of
Computed-Aided Detection, or CAD, technology (as utilized in Hologic's R2
ImageChecker CAD system) in mammography screening. There can be no assurance
that the effects demonstrated in the study described herein will be replicated
in any particular manner with respect to an individual patient as the actual
effect of the use of CAD technology in mammography screenings can only be
determined on a case-by-case basis depending on the particular circumstances
of the exam and patient in question. Hologic expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to the
data or statements presented herein to reflect any change in Hologic's
expectations or any change in events, conditions or circumstances on which any
such data or statements is based. Certain factors that could adversely affect
Hologic's business and prospects are described in Hologic's filings with the
Securities and Exchange Commission.
(1) M. Gromet, "Comparison of Computer-Aided Detection to Double Reading
of Screening Mammograms: Review of 231,221 Mammograms," AJR 2008;
190:1-6 [http://www.ajronline.org/]

(2) J. Fenton, et al. "Influence of Computer-Aided Detection on
Performance of Screening Mammography," New England Journal of
Medicine; 356:1399-1409

Contact:
Glenn Muir Frances Doria
Executive Vice President and CFO Director, Investor Relations
Hologic, Inc. Hologic, Inc.
Tel: 781.999.7300 Tel: 781.999.7377

SOURCE Hologic, Inc.

Glenn Muir, Executive Vice President and CFO, +1-781-999-7300, or Frances
Doria, Director, Investor Relations, +1-781-999-7377, both of Hologic, Inc.