New Patient Guidelines From American Medical Women's Association Recommend HPV Testing in Cervical Cancer Screening.

Business/Technology Editors & Health/Medical Writers

GAITHERSBURG, Md. & BOXBOROUGH, Mass.--(BUSINESS WIRE)--Jan. 7, 2002

Digene Corporation (Nasdaq: DIGE) and Cytyc Corporation (Nasdaq: CYTC) today announced that the American Medical Women's Association (AMWA) has developed new patient guidelines that recommend testing for human papillomavirus (HPV) for the millions of women each year who receive abnormal results known as ASCUS following their routine Pap test. According to the guidelines, an ASCUS (atypical squamous cells of undetermined significance) Pap test followed by HPV testing should identify most patients with a higher risk of cervical cancer, while reducing unnecessary follow-up procedures in women with no disease. The AMWA guidelines also recommend that women with ASCUS Pap results ask healthcare providers for their HPV test to be "reflexed" automatically from the same specimen when liquid-based cytology is used instead of the conventional Pap smear. According to the new guidelines, this management strategy further reduces overall costs and will minimize the need for another office visit. AMWA developed the guidelines in conjunction with the National HPV & Cervical Cancer Campaign for Cervical Cancer Month (January).

Digene's Hybrid Capture(R) 2 HPV DNA Test is the only FDA-approved test for HPV, which studies have shown is the primary causal factor in the development of cervical cancer. Numerous clinical studies have demonstrated the effectiveness of HPV testing as a follow-up to ASCUS Pap results and a recent study by the National Cancer Institute highlighted the benefits of HPV testing using Digene's hc2 HPV Test directly from Cytyc's ThinPrep(R) Pap Test(TM) vial in managing women with ASCUS Pap results. A number of published clinical studies have consistently demonstrated the improved performance of the ThinPrep Pap Test for the detection of low-grade and high-grade cervical disease when compared to the conventional Pap smear. The ThinPrep Pap Test is the only liquid cytology medium that is FDA-approved for reflex testing of Digene's hc2 HPV Test.

Evan Jones, Digene's Chairman and CEO, said, "We are extremely pleased that the American Medical Women's Association now recommends HPV testing for women with inconclusive Pap results. Their new patient guidelines reinforce strongly that HPV testing is increasingly becoming a standard of care in effective cervical cancer screening programs. We believe that HPV testing, using our Hybrid Capture(R) 2 HPV Test, can help provide women with ASCUS Pap results better, faster answers that can eliminate unnecessary anxiety as well as additional procedures."

"The ability to perform HPV testing directly from the ThinPrep Pap Test vial provides patients and their physicians access to the best cervical cancer screening technology while reducing unnecessary office visits," said Patrick J. Sullivan, Cytyc's President and Chief Executive Officer.

About Cytyc:

Cytyc Corporation develops, manufactures, and markets the ThinPrep(R) System for medical diagnostic applications. The ThinPrep System consists of the ThinPrep(R) 2000 Processor, ThinPrep(R) 3000 Processor, and related reagents, filters, and other supplies. Cytyc(R) and ThinPrep(R) are registered trademarks and ThinPrep(R) Pap Test(TM) is a trademark of Cytyc Corporation.

Forward-looking statements in this press release are made pursuant to the provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding product development and performance, constitute forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from those statements. Risks and uncertainties include, among others, dependence on proprietary technology, risks associated with competition and competitive pricing pressures, and other risks detailed in the Company's filings with the Securities and Exchange Commission, including under the heading "Certain Factors Which May Affect Future Results" in its 2000 Form 10-K filed with the Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in Company expectations or events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

About Digene:

Digene Corporation (Nasdaq: DIGE), based in Gaithersburg, Maryland, develops, manufactures and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases. The Company has developed and is commercializing its patented Hybrid Capture(R) products in three areas: women's cancers and infectious diseases, blood viruses, and genomics and pharmaceutical research. Digene's primary focus is in women's cancers and infectious diseases where the Company's lead product is the only FDA approved test for human papillomavirus, or HPV, which studies show is the cause of greater than 99% of cervical cancer cases. The Digene HPV Test is approved in the U.S. as an adjunct to the Pap test for cervical cancer screening and is being marketed in selected countries as a primary cervical cancer screen either in conjunction with or separate from the Pap test. This test is not approved for use as a primary cervical cancer screen in the U.S. The Company's product portfolio also includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, and tests for blood viruses. Please visit our website at: www.digene.com. For more information on HPV testing, please visit: www.thehpvtest.com.

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 which 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 payors, 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.