MARLBOROUGH, Mass.,
Nov. 12, 2015 /PRNewswire/ --
Researchers presented a new clinical-economic modeling analysis
this week showing that screening for cervical cancer with Pap+HPV
Together™ (co-testing) using the Aptima® HPV assay (an
mRNA-based HPV test) and the Aptima HPV 16 18/45 Genotype assay
could cost the health care system less money and prevent more cases
of invasive cervical cancer than screening with HPV alone* using a
DNA-based test.
Study results were presented in poster form as part of the
International Society For Pharmacoeconomics and Outcomes Research
(ISPOR) 18th Annual European Congress in Milan.
Researchers from the University of Southern
California and Truven Health Analytics performed
clinical-economic modeling analyses of screening with the Aptima
HPV assays in combination with the ThinPrep® Pap test,
and compared these results to screening with HPV alone using a
DNA-based test with HPV 16/18 genotyping and reflex cytology.
"This study demonstrates that eliminating the Pap test as part
of frontline screening would not reduce health care costs, despite
what some in the medical community have argued," said lead author
Juan Felix, MD, Chief of
Cytopathology, Los Angeles County
+ University of Southern California
Medical Center. "In fact, it's just the opposite. Co-testing,
specifically with an mRNA-based HPV assay, would be more clinically
effective and cost less money overall to the health care system
than screening with a DNA-based HPV test alone."
Study Design and Results
The study simulated the lifetime effects of screening women for
cervical cancer every three years from ages 30 to 70 using each
screening strategy. These results were then projected to the
current U.S. population.
The model predicted that compared to screening with HPV alone*
with a DNA-based test, screening with Pap+HPV Together using the
ThinPrep Pap test and Aptima HPV assays could, over the next 40
years1:
- Prevent nearly 150,000 cases of invasive cervical cancer.
- Save approximately $4 billion in
health care costs, based on a $39
difference for each 30-year-old woman modeled in the study.
These predictions were based on the estimate that screening with
HPV alone* could lead to 79 cases of invasive cervical cancer per
10,000 women, compared to 58 cases per 10,000 women when screening
with Pap+HPV Together. This represents a potential 37% increase in
cervical cancer cases, which contributed to increased treatment
costs in the study.
The new model complements results published earlier this year
from the largest retrospective, real-world study of cervical cancer
screening strategies to date (the Quest study),2 which
found that nearly one in five women with cervical cancer (18.6%)
could be missed by screening with HPV alone*. In addition, the new
cost-modeling study reinforces that screening with Pap+HPV Together
is the preferred method for women ages 30 to 65, as recommended by
consensus guidelines.3
"The more research we do, the stronger the case becomes for
keeping Pap+HPV Together as the preferred screening method for
cervical cancer," said Edward
Evantash, MD, Medical Director and Vice President of Medical
Affairs for Hologic. "Pap+HPV Together provides superior
protection against cervical cancer, and now is shown to be
cost-effective, for women over 30. As leaders in women's health, we
believe every woman is worth this protection."
The authors note that the study results depended on the
underlying performance of the Pap and HPV tests modeled in the
analysis as measured by sensitivity (the true positive rate) and
specificity (the rate of avoiding false positives). In
addition, the study used sensitivity estimates for liquid-based
cytology using image-guided technology, the current standard of
care.
While the Aptima HPV assay and DNA-based HPV tests both assess
the presence of high-risk HPV infection, the Aptima HPV assay also
detects the activity of HPV infection, identifying those infections
that are most likely to lead to cervical disease.4
As such, screening with the Aptima HPV assay reduces the rate of
false positives,4 which was a significant factor
in the difference in cost savings in the new study.
Conversely, screening for cervical cancer using a DNA-based HPV
test is associated with a higher rate of false
positives,4 which can lead to unnecessary follow-up and
referral of women to colposcopy. This ultimately causes additional
physical and emotional burden on women and increases health care
costs.4,5
About the Aptima HPV Assay and Pap+HPV Together
The Aptima HPV assay and the Pap test, which provides analysis
of cellular tissues and any changes, provide important information
for evaluating cervical cancer risk. In this modeling study, adding
the image-guided Pap test to frontline screening contributed to
cost-effectiveness given the Pap test's ability to identify women
at risk of developing cervical cancer.
Both Hologic's ThinPrep Pap test and its Aptima HPV assay are
the market-leading products for cervical cancer screening in
America. 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.
* A positive HPV screening result may lead to further evaluation
with cytology and/or colposcopy.
About Hologic
Hologic, Inc. 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 guarantee that these approaches will
be adopted by customers or that the products involved will 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, Science of Sure, Aptima, Pap+HPV Together, ThinPrep and
associated logos are trademarks and/or registered trademarks of
Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
Funding for the clinical-economic modeling study described in
this press release was provided by Hologic, Inc. (Marlborough, Massachusetts, USA)
Contact
Michael Watts
Vice President, Investor Relations and Corporate Communications
(858) 410-8588
michael.watts@hologic.com
References
- Felix, J., et al. Presented in poster form at ISPOR 18th Annual
European Congress, Milan, Italy,
Nov. 7-11, 2015.
- Blatt et al., Cancer Cytopathology. April 2015. (Study included ThinPrep Pap Test,
SurePath Pap Test, Hybrid Capture 2 assay)
- Saslow et al., Journal of Lower Genital Tract Disease.
November 2012.
- Aptima HPV Assay [package insert, AW-12820 Rev.001],
San Diego, CA; Hologic, Inc.,
2015. (Data in PI included ThinPrep Pap Test, Aptima HPV assay,
Hybrid Capture 2 assay)
- Sawaya G, Kuppermann M, Identifying a "range of reasonable
options" for cervical cancer screening. Obstet Gynec,
2015;125:308-310.
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SOURCE Hologic, Inc.