Healthcare Industry News:  Chlamydia 

Diagnostics Oncology Reimbursement

 News Release - September 28, 2006

California to Require Insurers to Cover HPV Testing in Cervical Cancer Screening

GAITHERSBURG, Md., Sept. 28 (HSMN NewsFeed) -- Digene Corporation (Nasdaq: DIGE ) announced today that Governor Arnold Schwarzenegger has signed a new bill requiring insurers in California to cover human papillomavirus (HPV) testing as part of cervical cancer screening (Senate Bill No. 1245). His action makes California the fifth state in the nation to have such a requirement and underscores the test's role as an emerging standard of care in screening. The Digene® HPV Test is the only FDA-approved test for high-risk types of HPV, and is approved for use along with a Pap test to screen women age 30 and older -- the group most at risk of cervical cancer.

The new legislation, introduced by Sen. Liz Figueroa (D-Fremont), requires health insurers to cover HPV testing as part of cervical cancer screening, upon the referral of the patient's healthcare provider. The bill had generated support from numerous health and women's advocacy groups, including the California Nurses Association, the California Medical Association, the California chapter of the American College of Obstetricians and Gynecologists, as well as several labor organizations.

"We applaud Gov. Schwarzenegger, Sen. Liz Figueroa and the state of California for helping to set a new, higher standard for preventive healthcare. By ensuring that more women have access to lifesaving technologies, we can help prevent women from needlessly dying of cervical cancer," said Robert Lilley, Digene's Senior Vice President of Global Sales and Marketing. "This new legislation further establishes California's role as a public health leader, while also showcasing the growing support for HPV testing from public health officials and health advocates around the country."

Other states requiring insurance coverage for HPV testing as part of cervical cancer screening are Maryland, New Mexico, Texas and West Virginia.

In studies involving more than 40,000 women and published in peer-reviewed publications, the combination of the Pap test and The Digene HPV Test was found to be significantly more sensitive in identifying women with high-grade cervical disease or cancer than the Pap alone. Leading medical organizations, including the American College of Obstetricians and Gynecologists and the American Cancer Society, have updated their cervical cancer screening guidelines to include HPV testing in routine cervical cancer screening for women aged 30 and older.

About Digene

Digene Corporation (Nasdaq: DIGE ), 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 U.S. Food and Drug Administration (FDA), 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® 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 Digene's HPV test is also CE-marked in Europe both routine, primary screening and follow-up evaluation of women with inconclusive Paps. It is marketed in more than 40 countries worldwide. In addition, Digene's product portfolio 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, Journalists may contact Pam Rasmussen, (301) 944-7196.

This press release contains 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, which could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of HPV testing by physicians, uncertainty of the company's future profitability, its ability to scale up manufacturing operations to meet any increased demand, the uncertainty regarding patents and proprietary rights, the success of the Company's marketing efforts, competition, risks inherent in international transactions, and the inability to obtain requisite additional financing, 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.

Source: Digene

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