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HPV Genotyping Can Benefit Clinical Practice, JNCI Study Concludes

Posted on: Tuesday, 26 July 2005, 09:01 CDT

GAITHERSBURG, Md., July 26 /PRNewswire-FirstCall/ -- A study published in the current issue of the Journal of the National Cancer Institute (JNCI) concludes that genotyping of specific high-risk types of the human papillomavirus (HPV), the cause of virtually all cases of cervical cancer, can benefit clinical practice by enabling more focused attention on women who are at highest risk, announced Digene Corporation .

In the study, the authors note they recently examined the performance of The Digene HPV Test and found that the test demonstrated superior sensitivity and negative predictive value compared with a single Pap smear. The authors added that with separate, follow-up, typing of HPV 16 and HPV 18, "This new screening strategy could help to reduce the number of women who are referred to colposcopy for a positive HPV test." Although women who carry other types of high-risk HPV "will still need to be followed more carefully" than those without HPV, follow-up could be more conservative.

The JNCI study, authored by Khan, Castle, et. al., is titled "The elevated 10-year risk of cervical neoplasia in women with human papillomavirus (HPV) type 16 or 18 may warrant type-specific HPV testing in clinical practice." It concludes that HPV screening that distinguishes specific HPV types from others -- specifically types 16 and 18 -- could "focus clinical attention on women at greatest risk [of cervical cancer] and permit less-aggressive management of other oncogenic infections." The findings are based on an evaluation of 20,810 women participating in the Kaiser Permanente health plan in Portland, OR, who were enrolled in a cohort study of HPV and cervical neoplasia.

"Primary screening with The Digene HPV Test together with the Pap is quickly emerging as the standard of care for cervical cancer screening, enabling greater screening sensitivity and enabling physicians to stratify and appropriately manage their patients at highest risk. To provide greater risk-stratification information to healthcare providers in the future, Digene is currently developing two products that can be used in the laboratory to provide HPV genotyping information following a positive high-risk HPV test," commented Attila T. Lorincz, PhD, Digene's Chief Scientific Officer and Senior Vice President of Research and Development. "We are strongly committed to our role as the pioneer in HPV screening and cervical cancer prevention."

About Digene

Digene Corporation , based in Gaithersburg, MD, develops, manufactures and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases -- with a focus on women's cancers and infectious diseases. The company's hc2 High-Risk HPV DNA Test is the only test for human papillomavirus approved by the FDA, and is approved for both follow-up evaluation in women with inconclusive Pap results and for primary adjunctive screening with the Pap test in women age 30 and older. For primary adjunctive screening, it is marketed as both The Digene HPV Test and the DNAwithPap(TM) Test. These brand names do not refer to the Digene product that tests for several types of the virus commonly referred to as "low-risk HPV," which are not associated with cervical cancer. For more information, visit http://www.thehpvtest.com/ . Digene's product portfolio also includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, as well as tests for blood viruses. For more information, visit the company's Web site, http://www.digene.com/ . Investors also may contact Charles Fleischman at 301-944-7000; journalists may contact Pam Rasmussen, 301-944-7196.

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of the future, as there are a number of meaningful factors that could cause the company's actual results to vary materially from those indicated by such forward-looking statements. Meaningful factors that could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of HPV testing by physicians and the extent of reimbursement for the HPV test by third-party payers, as well as other factors discussed in the company's Securities and Exchange Commission filings. For other factors, reference is made to the discussion in the company's annual and quarterly reports filed with the Securities and Exchange Commission.

Digene Corporation

CONTACT: Investors - Charles M. Fleischman, President, +1-301-944-7000,or Media - Shelley Ducker, +1-301-944-7610, both of Digene Corporation; orSean Leous of Financial Dynamics, +1-212-850-5600, for Digene Corporation

Web site: http://www.digene.com/http://www.thehpvtest.com/

Source: PRNewswire-FirstCall

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