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Qiagen, Roche See Good News in Changes to HPV Testing Guidelines

NEW YORK (GenomeWeb News) – Qiagen and Roche today welcomed new guidelines recommending the use of molecular testing for human papillomavirus screening in conjunction with Pap smears.

The US Preventive Services Task Force today recommended HPV testing along with Pap smears for women between 30 and 65 years of age, to be done every five years. At the same time, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology issued a guideline calling for HPV genotype testing for HPV types 16 and 18 following Pap Smears.

HPV 16 and 18 cause about 70 percent of all cervical cancers.

Mizuho Securities analyst Peter Lawson said in a note that the USPSTF's decision is a positive for Qiagen, and ACS, ASCCP, and ASCP's new guidelines are a positive for Roche and Hologic.

The USPSTF action alters a draft proposal it made in the fall that called for more evidence in order to determine the benefits of HPV testing.

The recommendations took note of Qiagen's digene HPV test, and while USPSTF falls short of explicitly recommending the test, it said the test has been evaluated in effectiveness trials, and added that "[a]lthough alternative HPV detection methods are emerging, the clinical comparability and implications of these methods are not completely understood."

According to Qiagen, more than 80 million digene HPV tests have been performed since it became available in 1997. Other firms with molecular HPV tests on the market include Roche, Gen-Probe, and Hologic.

ACS, ASCCP, and ASCP also supported HPV testing in addition to Pap Smears in their guideline.

"The key to reducing the burden of cervical cancer is to improve screening, and the clear views of these organizations is for women in the relevant age groups to receive co-testing with cytology and HPV testing," Ellen Sheets, chief medical officer of Qiagen, said in a statement. "We are convinced that these guidelines will help drive the momentum to shift toward co-testing in the US and further reduce the often fatal burden of cervical cancer."

Meanwhile, ACS, ASCCP, and ASCP revised guidelines issued in 2002 and specifically recommended that HPV testing for types 16 and 18 be done for women with a negative Pap smear but who test positive for "pooled" high-risk HPV types.

"The Pap test has successfully lowered cervical cancer deaths," ASCP said in a statement. "However, false-negative results are common, and any single test is not as sensitive as previously thought for detecting," cervical intraepithelial neoplasia grade 3, a precancerous lesion.

"On the other hand, HPV tests are more sensitive than the Pap test for precancer and may also be better at forecasting which women will develop CIN3-positive over the next five to 15 years," ASCP added.

The guidelines do not specifically recommend Roche's cobas HPV test, but it is the only test approved by the US Food and Drug Administration that gives results for the high-risk genotypes and individual results for HPV 16 and 18.

"Cervical cancer is effectively treated in its early stages and, as an organization committed to women's health, Roche Diagnostics is dedicated to helping eliminate this disease and improve patient care," Paul Brown, head of Roche Molecular Diagnostics, said in a statement.

According to Mizuho's Lawson, Qiagen should see some short-term gains from the USPSTF action, but not in the longer term.

"The headline is positive for Qiagen," he said in an analyst note, "however, recommendations are known to take the most conservative stance, defaulting to the older technologies (Qiagen) and less accepting to comparable but newer technologies (Roche/Hologic/Gen-Probe)."

"The updated guidelines do not change our view that the HPV market is becoming increasingly competitive and that pricing will likely intensify as new entrants gain traction and the clinical labs look to reduce costs," Goldman Sachs analyst Isaac Ro said in a note today. "We do not believe these guidelines will have a major impact on actual cervical cancer screening in the immediate future, similar to how the initial lengthening of the Pap guidelines in 2009 did not have a major impact."

In Thursday trading on the Nasdaq, shares of Qiagen closed up 3 percent at $15.08, Gen-Probe closed up 1 percent at $66.92, and Hologic finished down a fraction of a percent at $21.26. In Switzerland, Roche's shares finished up a fraction of a percent at CHF 160.40.

Lawson added that the revised recommendations from ACS, ASCCP, and ASCP could benefit Roche, but noted that Hologic also has two separate tests, one for high-risk HPV, the Cervista HPV HR, and one for HPV 16/18, Cervista HPV 16/18. Both tests were cleared by the FDA in 2009.

Both Qiagen and Gen-Probe are developing their own 16/18 tests with an eye on FDA clearance, he added.

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