MARLBOROUGH, Mass.,
Sept. 14, 2017 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) is deeply concerned that the
United States Preventive Services Task Force (USPSTF) did not
include a grade for co-testing (also known as Pap+HPV Together) in
draft cervical cancer screening recommendations released this week.
These draft recommendations do not consider the wealth of data
supporting the value of co-testing, and will put the lives of
American women at risk if implemented.
"These draft recommendations represent a significant change from
current practice and are a clear step back in protecting women from
cervical cancer," said Steve
MacMillan, Hologic's Chairman, President and Chief Executive
Officer. "We are concerned that lives will be lost if women are
denied access to co-testing if these draft
recommendations are implemented."
Multiple large studies conducted in the United States demonstrate that screening
with co-testing identifies more cervical pre-cancer and cancer than
either test used alone.1,2,3,4,5,6 In fact, the largest
retrospective study of cervical cancer screening strategies found
that nearly one out of five cases of cervical cancer was
missed with HPV alone screening.*2
Evidence cited in the USPSTF draft recommendations relied
heavily on studies conducted outside the
United States, including some that employed cytology methods
no longer widely used in the United
States, and HPV tests that are not FDA-approved for primary
use. Further, the USPSTF cited findings from a modeling study that
potentially unfairly skewed results in favor of HPV alone
testing.
"We find it disturbing that the USPSTF did not place more weight
on the results of important studies in American women, but instead
included European studies employing outdated technologies that have
limited, if any, relevance to the U.S. healthcare landscape," said
Edward Evantash, M.D., Hologic's
Medical Director and Vice President, Medical Affairs. "Further, the
limited information available on the design of the modeling study
makes it difficult to interpret the results, but it seems to defy
logic that these two valuable tests together did not perform as
well as HPV alone testing."
The draft recommendations also grant a grade A to the Pap test
at a three-year interval for women ages 21-65. Hologic believes
strongly in the power of the Pap test and the valuable contribution
it has made to women's health. Before introduction of the Pap test,
cervical cancer was the leading cause of cancer related deaths for
women in the U.S., but now ranks 14th in frequency.7
Studies demonstrate, however, that administering a Pap and HPV test
at the same time is the ideal strategy for detecting cervical
cancer and pre-cancer in women ages 30 and older.3,4,5
Large, U.S.-based studies also show that a co-testing interval of
three years is optimal.8,9
"We urge USPSTF to reinstate an A grade for co-testing and to
add language within revised recommendations to allow screening
interval flexibility for healthcare providers and their patients,
as was recently recommended by the Health Resources and Services
Administration (HRSA) in their Women's Preventive Health Services
Guidelines,"10 said Dr. Evantash.
The preponderance of available data supports co-testing every
three years as the optimal strategy for preventing cervical cancer.
Along with the clinical community, professional societies and
others, Hologic will submit formal comments to the USPSTF during
the public comment period to ensure that final USPSTF
recommendations place the health and well-being of women at the
forefront.
More information about the value of co-testing is available at
PapPlusHPV.com.
About Hologic
Hologic, Inc. is an innovative medical
technology company primarily focused on improving women's health
and well-being through early detection and treatment. 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 the use of Hologic's
diagnostic products. There can be no assurance these products 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 products 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, Pap+HPV Together, and ThinPrep are trademarks and/or
registered trademarks of Hologic, Inc. in the United States and/or other countries.
*A positive screening result may lead to further evaluation with
cytology and/or colposcopy.
Investor Contact:
Michael
Watts
+1 858.410.8588
michael.watts@hologic.com
Media Contact:
Jane
Mazur
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)
jane.mazur@hologic.com
References
- 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
- 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 [Study included ThinPrep®,
SurePath, Hybrid Capture 2 assay].
- Katki HA, Kinney WK, Fetterman B, et al. Cervical cancer risk
for women undergoing concurrent testing for human papillomavirus
and cervical cytology: a population-based study in routine clinical
practice. Lancet Oncol. 2011;12(7):663-72. PMID: 21684207.
http://dx.doi.org/10.1016/S1470-2045(11)70145-0.
- Gage JC, Hunt WC, Schiffman M, et al. Similar risk patters
after cervical screening in two large U.S. populations.
2016;128(6):1248-57.
- Gage JC, Schiffman M, Katki HA, et al. Reassurance against
future risk of precancer and cancer conferred by a negative human
papillomavirus test. J Natl Cancer Inst. 2014;106(8). PMID:
25038467. http://dx.doi.org/10.1093/jnci/dju153. Accessed
September 13, 2017.
- Katki HA, Schiffman M, Castle PE, et al. Five-year risks of CIN
3+ and cervical cancer among women who test Pap-negative but are
HPV-positive. J Low Genit Tract Dis. 2013;17(5 Suppl
1):S56-63.
- NIH Fact Sheets Home. Cervical Cancer.
https://www.report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=76.
Accessed September 13, 2017.
- Kinney W, Wright TC, Dinkelspiel HE, DeFrancesco M, Thomas Cox
J, Huh W. Increased cervical cancer risk associated with screening
at longer intervals. Obstet Gynecol.2015;125:311–315.
- Kulasingam SL, Havrilesky LJ, Ghebre R, Myers ER. Screening for
cervical cancer: A modeling study for the US Preventive Services
Task Force. J Lower Genit Tract Dis. 2013;17:193–202.
- HRSA. Women's Preventive Services Guidelines.
https://www.hrsa.gov/womensguidelines/. Accessed September 13, 2017.
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SOURCE Hologic, Inc.