Home-based self-collected vaginal specimens detect more cervical lesions and cancers than cytology

Hilden, Germany, and Gaithersburg, Md. (ots) -

Vaginal self-collection for Hybrid Capture®-based HPV testing
increases screening coverage and is more sensitive than Pap smear
shows a Mexican study published today online in the Lancet

Promising findings published today online in the Lancet[i] from a
community- based, randomized equivalence trial undertaken by public
health authorities in Mexico to investigate DNA home testing for
human papillomavirus (HPV) compared with cytology (evaluation of
cells) based on Pap smears. The study indicated that the relative
sensitivity of HPV molecular testing was 3.4 times higher than
cytology. Additionally, 4.2 times more invasive cancers were
detected. The home testing study adds support to previous
evidence[ii] that adding self-collection to the screening setup can
increase the coverage rate of cervical cancer prevention programs,
especially in underserved regions in developing and developed
countries. The study was funded by the Instituto Nacional de Salud
Pública (INSP), the Health Ministry of Mexico and QIAGEN.

"HPV testing is lower in cost, easier to implement, and has lower
false-negative rates than cytology. Testing of self-collected vaginal
samples offers increased coverage and acceptability," commented the
lead study author, Dr. Eduardo Lazcano-Ponce, professor at the Centro
de Investigación en Salud Poblacional of INSP in Morelos, Mexico.

The trial included 25,061 women of low socioeconomic status
between 26 to 65 years from 540 rural communities in Morelos,
Guerrero, and Mexico State, Mexico. They were randomly allocated to
HPV DNA testing of a vaginal sample self-collected at home or
cervical cytology at the nearest health center. Eight community
nurses visited the self-collection women at home and instructed them
how to use the digene® cervical sampler, a conical-shaped brush, to
take the sample. The study used the digene® HPV test based on Hybrid
Capture 2, which is considered the gold standard for HPV testing and
already has been clinically validated in trials including more than
one million women worldwide. The primary endpoint was CIN2 or worse,
detected by colposcopy. Any woman having a positive result for either
of the tests was referred to colposcopy.

The participation rate was higher in women randomized to the HPV
group (9,202 of 9,371, 98%) than in the cytology group (11,054 of
12,731, 87%). Importantly, in the HPV group more invasive cancers
were detected than with cytology (28 vs. 8). With a lower positive
predictive value for HPV testing (PPV CIN2 or worse 12.2% vs. 90.5%)
the identification of appropriate triage methods is crucial. The
study adds: "Because women at these sites will be screened only a few
times in their lives, the high sensitivity of a HPV screen is of
paramount importance."

Based on data from several national trials including Hybrid
Capture technology, Mexico is the first country to implement
frontline HPV testing with cytology triage as a national cervical
cancer prevention program. Dr. Nubia Munoz, Colombian Cancer
Institute, Bogota, Colombia, and Dr. Rolando Herrero, Prevention and
Implementation Group, International Agency for Research on Cancer,
Lyon, France, conclude in an accompanying editorial in the Lancet:
"The experience shows what can be achieved when scientific judgment
guides public health policy."

"The value of HPV DNA testing in cervical cancer screening and
disease detection has been proven again and again for both the
developed and developing worlds. Self-collection for HPV DNA testing
could become an important way for national cervical cancer prevention
programs worldwide to increase coverage rates," said Dr. Helge
Lubenow, Head of the Molecular Diagnostic Business at QIAGEN. "Our
digene HPV testing solutions have been used in several trials for
self-collection, and we support any approach that helps to include
populations that are difficult to reach as here are most cases of
cancer to be found."

About cervical cancer and the digene® HPV test

Worldwide, cervical cancer affects approximately 500,000 women
annually and, after breast cancer, is the second-most-common
malignancy found in women. Since the cause of cervical cancer - HPV -
is known and women who have it can be identified, it is a highly
preventable and treatable disease if women have access to organized
prevention programs. The World Health Organization estimates that
only about five percent of women in the developing world have been
screened for cervical disease in the previous five years compared to
75 percent in the developed world. In the U.S., the digene HPV Test
is approved for use together with a Pap test in women 30 years and
older. In Europe, it is approved as an initial general population
screening test either alone or together with a Pap test. It is also
used as a follow-up to inconclusive Pap test results. For more
information about HPV and cervical cancer, visit www.theHPVtest.com .

About self-collected samples

HPV testing offers the ability for women to self-collect a
specimen that can be sent to a laboratory for testing; this cannot be
done with a pap smear. Specimens are self-collected in either a
clinical setting or in a home. Several health authorities, e.g. in
the Netherlands and Mexico, have already investigated the
effectiveness of self-collected specimens to determine if it could
increase the coverage and effectiveness of their cervical cancer
screening program and reach women who today are unscreened. Trials in
both countries have shown very promising results and both have used
the digene HPV test as the test for screening. Therefore, self-
collection could be a useful addition to cervical cancer screening
programs and when new algorithms are implemented that incorporate HPV
DNA testing. This is true for both developing countries as well as in
the developed world. Currently the digene HPV test is validated using
digene Cervical Sampler and is not validated for use with
self-collected specimens.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global
provider of sample and assay technologies. Sample technologies are
used to isolate and process DNA, RNA and proteins from biological
samples such as blood or tissue. Assay technologies are used to make
such isolated bio-molecules visible. QIAGEN has developed and markets
more than 500 sample and assay products as well as automated
solutions for such consumables. The company provides its products to
molecular diagnostics laboratories, academic researchers,
pharmaceutical and biotechnology companies, and applied testing
customers for purposes such as forensics, animal or food testing and
pharmaceutical process control. QIAGEN's assay technologies include
one of the broadest panels of molecular diagnostic tests available
worldwide. This panel includes the digene HPV Test, which is regarded
as a "gold standard" in testing for high-risk types of human
papillomavirus (HPV), the primary cause of cervical cancer, as well
as a broad suite of solutions for infectious disease testing and
companion diagnostics. QIAGEN employs about 3,700 people in over 35
locations worldwide. Further information about QIAGEN can be found at
http://www.qiagen.com/ .

[i] Lazcano-Ponce, E. et al. (2011) Self-collection of vaginal
specimens for human papillomavirus testing in cervical prevention
(MARCH): a community-based randomised controlled trial. Lancet 378.
Published Online November 2, 2011 DOI:10.1016/S0140-6736(11)61522-5.

[ii] Gök, M. et al. (2011) Experience with high-risk human
papillomavirus testing on vaginal brushbased self-samples of
non-attendees of the cervical screening program. Int J Cancer. doi:
10.1002/ijc.26128.

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