MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that the ThinPrep® Genesis
processor for cytology slide and molecular test preparation has received
a CE IVD mark in Europe. The system features increased automation
capabilities, together with ergonomic and chain of custody benefits,
compared to older instruments. Most importantly, the instrument will
prepare slides for cytology as well as aliquot samples for molecular
testing, reducing manual sample handling.
The Genesis processor is the latest extension of the ThinPrep portfolio,
which revolutionized and increased the accuracy of cervical cancer
screening with the first liquid-based Pap test in 1996. Hologic launched
an updated ThinPrep® 2000 processor in 2017 and received FDA
approval in 2018 for the ThinPrep® Integrated Imager, which
guides cytotechnologists to areas showing potential abnormal cells.
Studies have shown that automated, assisted imaging can increase the
sensitivity of detecting suspicious cells compared to manual slide
review.1-4
“The launch of the ThinPrep Genesis processor reflects our ongoing
commitment to helping our lab customers deliver accurate and reliable
results to clinicians and patients, while maximizing their operational
efficiency,” said Jan Verstreken, Hologic’s Regional President, EMEA and
Canada. “Over the last 30 years, mortality from cervical cancer has
fallen significantly in the developed world, largely due to screening
programs that identify abnormalities before they become cervical cancer.”
The ThinPrep Genesis processor provides the same trusted reliability as
the ThinPrep 2000 system for cytology slide processing, with added
features such as automated aliquoting for molecular testing. The
processor also provides automated barcoding of samples, ensuring
accurate sample tracking as well as reducing manual steps. The increased
automation is expected to deliver ergonomic benefits by reducing
repetitive strain.
To learn more about ThinPrep Pap test products, please visit: https://healthdxs.com/en/thinprep/.
About Cervical Cancer and Pap+HPV Together
Hologic is a leading supplier in Europe of Pap tests (ThinPrep) and HPV
tests (Aptima®). These tests can be used on the same sample to screen
for cervical pre-cancer and cancer (independently or together for
co-testing: Pap+HPV together).
Data from 2018 indicate that in Europe, more than 60,000 women were
diagnosed with cervical cancer and approximately 25,000 died from the
disease.5 Before introduction of the Pap test, cervical
cancer was the leading cause of cancer-related deaths for women in
Europe, but now ranks 9th in frequency.5
About eight out of 10 women will contract HPV, the virus that causes
cervical cancer, at some point in their lives, but most of the time the
virus goes away. In some cases, however, it can remain and promote
development of cervical cancer. For women between 30 and 65, the
co-testing screening approach has been shown to detect 95 percent of
cervical cancer cases.6 Screening with both tests also
prevents more cases of pre-cancer than either test used alone.6 In
fact, the largest retrospective study of cervical cancer testing
strategies found that one out of five cases of cancer was missed when
the HPV test was used alone.6
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, ThinPrep, Aptima, and The Science of Sure are trademarks and/or
registered trademarks of Hologic, Inc. in the United States and/or other
countries.
References
-
Dziura B, et al. Performance of an imaging system vs. manual screening
in the detection of squamous intra epithelial lesions of the uterine
cervix. Acta Cytol. 2006;50(3):309-11.
-
Lozano R. Comparison of computer-assisted and manual screening of
cervical cytology. Gynecol Oncol. 2007;104(1):134-8.
-
Miller FS, et al. Implementation of the ThinPrep imaging system in a
high-volume metropolitan laboratory. Diagn Cytopathol. 2007;35(4):213-7.4.
-
Klug SJ, et al. A randomized trial comparing conventional cytology to
liquid-based cytology and computer assistance. Int J Cancer. 2012;132(12):2849-57.
doi:10.1002/ijc.27955.
-
ICO/IARC Information Centre on HPV and Cancer (HPV Information
Centre). Human Papillomavirus and Related Diseases Report, 17 April
2018. http://www.hpvcentre.net/statistics/reports/XEX.pdf1
-
Blatt et al. Comparison of cervical cancer screening results among
256,648 women in multiple clinical practices. Cancer
Cytopathology. 2015;123(5):282-288 [Study included ThinPrep®,
SurePath®, Hybrid Capture® 2 assay].
SOURCE: Hologic, Inc.