AEGiS-PRn: HCFA Establishes Reimbursement For Digene's HPV Test

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

HCFA Establishes Reimbursement For Digene's HPV Test

PR Newswire; Tuesday December 9, 7:30 am EST

BELTSVILLE, Md., Dec. 9 /PRNewswire/ -- Digene Corporation (Nasdaq: DIGE - news) announced today that the Health Care Financing Administration (HCFA), administrator for Medicaid and Medicare, has established reimbursement payment amounts for human papillomavirus (HPV) testing that will take effect January 1, 1998. Digene's lead product, the Hybrid Capture(R) HPV DNA test, is the only test approved by the Food and Drug Administration (FDA) for the detection of HPV, the cause of essentially all cervical cancer.

Evan Jones, Digene's President and Chief Executive Officer, commented, "HCFA's decision to reimburse for our HPV test, following announcement by the American Medical Association that new CPT codes have been assigned specifically for HPV DNA testing, highlights the growing recognition of the value of Digene\022s test for cervical cancer screening and prevention. The new codes will significantly improve the processing of claims and will standardize the reimbursement amount for the Digene Hybrid Capture HPV test."

Digene Corporation develops, manufactures and markets DNA and RNA tests for the detection, screening and monitoring of human diseases. Digene's products are designed to help improve clinical outcomes and reduce the overall cost of disease management. The Company's HPV test allows physicians to identify women who are most at risk of having or developing cervical disease and cervical cancer. Digene's HPV test has been approved by the FDA as an adjunct to the Pap smear for cervical cancer screening and is being marketed in selected European and South American countries as a primary cervical cancer screen either in conjunction with or separate from the Pap smear. In addition, Digene has developed and launched tests internationally for the detection and viral load monitoring of major blood viruses, including human immunodeficiency virus (HIV), cytomegalovirus (CMV) and hepatitis B virus (HBV), and tests for the detection of two of the most common sexually transmitted diseases, chlamydia trachomatis and neisseria gonorrhea. Digene's proprietary DNA and RNA detection systems are based on its Hybrid Capture technology. The Company believes that Hybrid Capture represents a significant improvement over existing technologies because of its sensitivity, speed, ease-of-use, accuracy and ability to measure viral load.

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may vary materially from expectations. Meaningful factors which could cause actual results to differ from expectations include, but are not limited to, uncertainty of future profitability, uncertainty of market acceptance, risks inherent in international transactions, dependence on third party reimbursement, competition, dependence on European distributor, extent of government regulations, and the uncertainty regarding patents and proprietary rights, as well as other factors discussed in the Company's Securities and Exchange Commission filings.

Digene provides a Reimbursement Helpline to assist health care providers in their transition to the new codes. This free service is available to reimbursement payors, laboratory personnel, and physicians and their staff, Monday to Friday from 8:30 am to 5:30 pm ET at 1-888-CPT 4 HPV.

SOURCE: Digene Corporation

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