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Biotech / Medical : Searching for Biotech winners!

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To: John O'Neill who wrote (1)1/31/1998 12:55:00 AM
From: WTT2   of 22
 
Here is my pick for '98 Digene. It has underperformed the last couple of weeks in my opinion becouse of a lack of PR. Today they announced a new cervical test introduced in Europe. They also have been approved for rembursement by medicare and medicad: Below I have included a quick desc. from HOOVERS and the Two recent press releases. Also of interest Putnum Investments Filed a 13d on01-20-98 due to them aquiring 900,000 shares.

Digene's proprietary blood tests detect and monitor such diseases as hepatitis B and HIV. Its flagship product is the Hybrid Capture HPV test, which screens for the virus that causes almost all cervical cancer. The company has also developed tests that screen for chlamydia, gonorrhea, and cytomegalovirus (the most common viral infection in AIDS patients). Digene's products involve hundreds of biological components which the company combines itself, as well as some components purchased from outside vendors. The company focuses its sales on the women's health market and sells directly and through distribution channels to more than 500 customers worldwide.

New test for cervical cancer launched in Europe

VIENNA, Jan 30 (Reuters) - A new test for cervical cancer, which doctors believe could dramatically cut deaths from the disease, was launched in Europe on Friday.

Digene Europe, a subsidiary of Digene Corp (DIGE.O) of the United States presented its Hybrid Capture HPV DNA test at a conference of gynaecologists in Vienna.

The test will be used along with conventional PAP smear screening to detect the human papilloma virus (HPV) which is linked to the disease.

''Use of the HPV test as part of cervical screening could prevent 90 percent of all (cervical) cancer cases,'' Dr Karl Ulrich Petry, of the Krankenhaus Oststadt, in Hannover, Germany, said in a statement.

Cervical cancer is one of the most common malignant diseases in women and is second only to breast cancer in causing deaths. Medical experts say the disease is preventable if it is caught early.

PAP smear screening, in which cells from the cervix, or neck of the womb, are examined for abnormal appearance before they become cancerous, has saved many lives but depends on the expertise of those examining the results.

Gynaecologists hope the new HPV test will identify cases missed by the PAP smear.

''A test that is able to detect changes in a much higher proportion of cases is a great advance. It may mean that we only need to screen every five years in some women, rather than every three years, while at the same time identifying more cases of disease,'' Professor Jack Cuzick of the Imperial Cancer Research Fund in London said in a statement.

The HPV test is also performed on cervical cells but because it is a molecular test which is automated it does not depend on human judgement. In addition to identifying cervical cancer it can tell which women are more likely to develop the disease in the future.

The Digene test has already been approved by the U.S. Food and Drug Administration for the detection of HPV.

Human error in evaluating PAP smears in Britain has been blamed for thousands of re-screenings and several women have allegedly died due to the blunders. ^REUTERS@

10:17 01-30-98

HCFA Establishes Reimbursement For Digene's HPV Test

BELTSVILLE, Md., Dec. 9 /PRNewswire/ -- Digene Corporation (Nasdaq: DIGE) 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 Digenes 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.

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.
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