MARLBOROUGH, Mass.,
May 3, 2016 /PRNewswire/ -- A
new cervical cancer screening study demonstrates that Pap+HPV
Together™ (co-testing) remains the most effective
strategy for detecting high-grade cervical
lesions1,2, Hologic, Inc. (Nasdaq: HOLX) announced
today. The study, published this month in Cancer
Cytopathology, a peer-reviewed journal of the American Cancer
Society, also showed no significant difference between the
sensitivities of the Pap and HPV tests when either was used alone
as a primary screening method.1
- Study details1: The authors, from Houston
Methodist Hospital, evaluated a database with 130,648 Pap test
results. Of these patients, 47,499 were screened with Pap+HPV
Together and 1,654 underwent follow-up biopsies. The HPV test
results were performed using the cobas® HPV test and
cobas® 4800 System from Roche Diagnostics, while the Pap
tests were performed with the ThinPrep® Pap test (a
liquid-based test) from Hologic or the SurePath™
liquid-based Pap test from BD Diagnostics.
Key takeaways1: The study confirmed that
screening with Pap+HPV Together detected more cases of pre-cancer
and cancer than either test used alone. Pap+HPV Together missed
significantly fewer cases of high-grade cervicovaginal lesions –
only 1.2 percent – compared to either the cobas HPV test (8.7
percent) or the Pap test (9.1 percent) when used alone. Further,
when used alone as primary screening methods, sensitivity results
for the cobas HPV test and the Pap tests were comparable, according
to the study.
The researchers concluded, "Our data strongly support the view
that currently, cytology-HPV co-testing is the best strategy for
screening women who are 30 years old or older."
"With data continuing to mount that screening with Pap+HPV
Together is more effective than screening with either HPV or Pap
alone in women over 30, the clinical benefit of continuing the
co-testing strategy is clear," said Edward
Evantash, M.D., Medical Director and Vice President of
Medical Affairs, Hologic. "This study underscores the value of
real-world data in accurately reflecting test performance as
compared to clinical trial results alone."
The Pap test performance in the study aligned with the College
of American Pathologists (CAP) benchmarking database, demonstrating
that when cytology performance is on par with U.S. national
averages, co-testing performance is optimized.
The study further supports current consensus guidelines from
multiple organizations, including the American Congress of
Obstetricians and Gynecologists, which recommends screening for
cervical cancer with a Pap test and an HPV test together for women
ages 30 to 65.3
"All women deserve the best possible protection against cervical
cancer, which is once again proven to be the use of Pap and HPV
tests together," said Evantash. "Offering HPV-alone screening would
be a step backward and unnecessarily put women's lives at
risk."
The new study corroborates previous research, including the
largest retrospective cervical cancer screening study conducted in
the United States, the 2015 Quest
Study.2 The Quest Study found that Pap+HPV Together
identified more cervical pre-cancer and cancer than either test
used alone,2 and demonstrated that one in five cases of
cervical cancer was missed with HPV-alone
screening.2*
About Pap+HPV Together
Both Hologic's ThinPrep® Pap test and its
Aptima® HPV Assay are the market-leading products for
cervical cancer screening in the U.S. To learn more about the
importance of screening with Pap+HPV Together using an mRNA-based
test like the Aptima HPV Assay, visit www.PapPlusHPV.com.
About Hologic
Hologic, Inc. (Nasdaq: HOLX) is a leading developer,
manufacturer and supplier of premium diagnostic products, medical
imaging systems and surgical products. The Company's core business
units focus on diagnostics, breast health, GYN surgical, and
skeletal health. With a unified suite of technologies and a robust
research and development program, Hologic is dedicated to The
Science of Sure. For more information on Hologic, visit
www.hologic.com.
Forward-Looking Statements
This press release may contain forward-looking information that
involves risks and uncertainties, including statements about
approaches to cervical cancer screening. There can be no
assurance these approaches will achieve the benefits described
herein or that such benefits will be replicated in any particular
manner with respect to an individual patient. The actual
effect of the use of the approaches can only be determined on a
case-by-case basis depending on the particular circumstances and
patient in question. In addition, there can be no assurance
that these products will be commercially successful or achieve any
expected level of sales. Hologic expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any such statements presented herein to reflect any
change in expectations or any change in events, conditions or
circumstances on which any such statements are based.
Hologic, Aptima, Pap+HPV Together, ThinPrep, and The Science of
Sure are trademarks and/or registered trademarks of Hologic, Inc.
in the United States and/or other
countries. COBAS is a trademark of Roche, and SurePath is a
trademark of Becton Dickinson.
*A positive HPV screening result may lead to further evaluation
with cytology and/or colposcopy.
Media Contact
Jane
Mazur
Senior Director, Divisional Communications
(585) 355-5978
jane.mazur@hologic.com
Investor Contact
Michael
Watts
Vice President, Investor Relations and Corporate Communications
(858) 410-8588
michael.watts@hologic.com
___________________________
References
1.
|
Zhou, H., Mody, R.
R., Luna, E., Armylagos, D., Xu, J., Schwartz, M. R., Mody, D. R.
and Ge, Y. (2016), Clinical performance of the Food and Drug
Administration–Approved high-risk HPV test for the detection of
high-grade cervicovaginal lesions. Cancer Cytopathology.
doi: 10.1002/cncy.21687
|
2.
|
Blatt, A. J.,
Kennedy, R., Luff, R. D., Austin, R. M. and Rabin, D. S. (2015),
Comparison of cervical cancer screening results among 256,648 women
in multiple clinical practices. Cancer Cytopathology, 123:
282–288. doi: 10.1002/cncy.21544
|
3.
|
Saslow, et al.
American Cancer Society, American Society for Colposcopy and
Cervical Pathology, and American Society for Clinical Pathology
Screening Guidelines for the Prevention and Early Detection of
Cervical Cancer. Am J Clin Pathol. 2012;137:516-42.
doi:10.1309/AJCPTGD94EVRSJCG.
|
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SOURCE Hologic, Inc.