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Trovagene Launches Easier Test for HPV Infection

By Pharmaceutical Processing | March 28, 2013

TRENTON, N.J. (AP) — Shares of Trovagene Inc. jumped Wednesday after the maker of molecular disease-detecting tests launched its new urine-based test for a common, sexually transmitted virus that can cause cervical cancer, some other cancer types and genital warts.

Trovagene said the HPV High Risk test looks for 15 different strains of human papilloma virus most likely to cause disease. It involves sophisticated genetic testing of a urine sample to detect snippets of DNA from those 15 strains, all of which can cause cervical cancer, but not genital warts.

The virus, called HPV for short, is the most common sexually transmitted one in the country. About 14 million people are infected each year, and 80 percent of all women are exposed to HPV at some point. According to the Centers for Disease Control and Prevention, HPV lurks in an estimated 79 million American women and men, most of whom don’t know it.

That’s because there is no general HPV test, there’s none approved for some of the diseases it can cause and most women getting a routine Pap smear don’t get a separate test for HPV at the same time.

The U.S. Preventive Services Task Force, aiming to increase awareness and limit spread of HPV, last year recommended that DNA testing for HPV infection be a mandatory part of women’s screenings for cervical cancer.

Both those tests involve an uncomfortable procedure in which a metal instrument is inserted in the vagina to collect cells from the cervix. With a Pap smear, the cells are analyzed for the presence of cancer or pre-cancerous changes, while the HPV test looks for the virus itself.

San Diego-based Trovagene said its product might help overcome roadblocks to widespread testing for HPV, namely the cost, inconvenience and resistance of some patients to the invasive collection of cells from the cervix.

There are at least a few dozen types of HPV. Different types can cause cancer of the cervix, genital warts, warts growing in the throat and, less commonly, cancers of the throat, vagina, vulva, penis and anus.

About 90 percent of HPV infections go away on their own within a couple of years, knocked out by the body’s immune system. Patients diagnosed with an HPV infection typically get follow-up tests every six to 12 months to see whether the infection has cleared up or persisted long enough to require treatment.

The Trovagene test, soon to be available through health care providers, would make follow-up tests after diagnosis easier.

Chances of HPV infection can be reduced by use of condoms, limiting number of sexual partners and immunization against most disease-causing types. Two vaccines are recommended for adolescent boys and girls and for men and women through age 26: Merck & Co.’s Gardasil and GlaxoSmithKline PLC’s Cervarix.

Trovagene shares rose 35 cents, or 6.1 percent, to $6.10 in regular trading Wednesday, then climbed another 65 cents, or 10.7 percent, to $6.75 in after-hours trading. Shares have traded in a range of $1.86 to $8.96 over the past 52 weeks.

___

Follow Linda A. Johnson on Twitter at http://twitter.com/LindaJ_onPharma

 

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