German Association of Gynecology and Obstetrics Recommends HPV Testing for Cervical Cancer Screening

SOURCE:

Qiagen N.V.

2008-08-04 15:09:00

German Association of Gynecology and Obstetrics Recommends HPV Testing for Cervical Cancer Screening

VENLO, THE NETHERLANDS–(EMWPresswire – August 4, 2008) – New cervical cancer

prevention guidelines issued by the German Association for

Gynecology

and Obstetrics (DGGG) recommend testing women 30 and over for

HPV

(human papillomavirus) — the primary cause of cervical cancer.

The

guidelines recommend that HPV testing be performed along with a

Pap

smear for women 30 and older. The digene® HPV Test, developed

by

QIAGEN (NASDAQ: QGEN) (Frankfurt, Prime Standard: QIA), is

currently

the only HPV test approved by regulatory authorities in both

Europe

and the United States.

“Our recommendations recognize the large number of scientific

studies

that demonstrate greater accuracy in identifying women at risk

of

having or developing cervical cancer, when a Pap is combined with

the

HPV test, rather than relying on a Pap smear alone,” says

Professor

Klaus Friese, lead author of the new guidelines and professor

of

gynecology at the Ludwig-Maximilians-University in Munich. “By

using

both tests for women 30 and over, when cervical cancer is

most

common, we hope to greatly reduce the number of women suffering

and

dying from this disease.”

The DGGG guidelines specifically conclude that the sensitivity of

the

Hybrid Capture® II (HC2) technology used by the digene HPV Test

is

comparable to PCR, the standard technology used in molecular

testing.

However, say the guidelines, the specificity (association with

actual

disease) of HC2 is greater than that for PCR.

Every year, cervical cancer affects nearly 500,000 women

worldwide

and, after breast cancer, is the second-most-common malignancy

in

women. In Germany, 6,200 women are diagnosed with the disease

and

1,800 die from it each year. It is estimated that 80 percent of

women

will get an HPV infection at some point in their lives. In

most

cases, the infection is cleared by the immune system or is

suppressed

without causing problems. However, in others, the infection

persists,

leading to abnormal cell changes and disease. Early detection

allows

early treatment, ideally before cancer develops.

The digene HPV Test has been validated in global studies

that

included more than 300,000 women. It has been approved by the

U.S.

Food and Drug Administration, is CE-marked in Europe and is

also

licensed for sale in many other countries. In Germany, the digene

HPV

Test is reimbursed by most private health insurances for

routine

screening. Many experts hope that public health insurance will

cover

HPV testing in the future for primary screening in conjunction

with a

Pap. One pilot screening program already initiated is a

partnership

between public health insurer Deutsche BKK, the Wolfsburg

clinical

centre and gynecologists in private practice in the city. In

the

program, Deutsche BKK covers the cost of the digene HPV Test as

a

screening test for participants 30 years and older, in

conjunction

with a Pap.

“Unlike other cancers, cervical cancer is virtually 100

percent

preventable — if women and their healthcare providers have access

to

the HPV Test and other new advances in preventive care,” says

Peer

Schatz, CEO of QIAGEN. “The new guidelines from the

German

Association of Gynecology and Obstetrics will play a valuable role

in

helping physicians — and through them, their patients —

understand

the most effective methods for making this disease a tragedy of

the

past. QIAGEN welcomes the new guidelines published by the DGGG

in

Germany, a country with a population of more than 80 million and

in

which the company has a strong presence.”

About QIAGEN:

QIAGEN N.V., a Netherlands holding company, is the leading

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 biomolecules visible. QIAGEN has developed and markets

more

than 500 consumable 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 what is considered to

be

the broadest panel of molecular diagnostic tests available

worldwide.

This panel includes the only FDA-approved test for

human

papillomavirus (HPV), the primary cause of cervical cancer.

QIAGEN

employs more than 2,800 people in more than 30 locations

worldwide.

Further information about QIAGEN can be found

at

http://www.qiagen.com/.

SAFE HARBOR STATEMENT

Certain of the statements contained in this news release may

be

considered forward-looking statements within the meaning of

Section

27A of the U.S. Securities Act of 1933, as amended, and Section

21E

of the U.S. Securities Exchange Act of 1934, as amended. To

the

extent that any of the statements contained herein relating

to

QIAGEN’s products, markets, strategy or operating results

are

forward-looking, such statements are based on current

expectations

that involve a number of uncertainties and risks. Such

uncertainties

and risks include, but are not limited to, risks associated

with

management of growth and international operations (including

the

effects of currency fluctuations and risks of dependency

on

logistics), variability of operating results, the

commercial

development of the applied testing markets, clinical research

markets

and proteomics markets, nucleic acid-based molecular

diagnostics

market, and genetic vaccination and gene therapy

markets,

competition, rapid or unexpected changes in

technologies,

fluctuations in demand for QIAGEN’s, products (including

fluctuations

due to the level and timing of customers’ funding, budgets, and

other

factors), our ability to obtain regulatory approval of our

infectious

disease panels, difficulties in successfully adapting

QIAGEN’s

products to integrated solutions and producing such products,

the

ability of QIAGEN to identify and develop new products and

to

differentiate its products from competitors’ products,

market

acceptance of QIAGEN’s new products and the integration of

acquired

technologies and businesses. For further information, refer to

the

discussions in reports that QIAGEN has filed with, or furnished

to,

the U.S. Securities and Exchange Commission (SEC).

Copyright © Hugin AS 2008. All rights reserved.

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