Aiming to Develop Novel Cervical Cancer Screening Test

SAN DIEGO, CA – TrovaGene, Inc., is preparing to launch clinical studies aimed at developing the first non-invasive, urine-based screening test for the human papilloma virus (HPV) that causes cervical cancer, a top officer of the molecular diagnostics products company announced today.

“We expect the studies to commence in the first quarter of next year,” said Kerry Segal, TrovaGene’s Chief Business Officer.

"The studies will be conducted in collaboration with world-renowned U.S. and European thought leaders in primary cervical cancer screening with access to patients undergoing treatment for cervical cancer," he said.

According to the Centers for Disease Control and Prevention (CDC), as many as 80% of women, and 50% of men and women combined, will get genital HPV at some point in their lives. Most of these infections go away or are suppressed by the body without problem, the CDC said.

However, about 11,000 American women are diagnosed with cervical cancer caused by HPV, and there are about 4,000 deaths per year from this sexually-transmitted disease. The figures worldwide are more dramatic – there are an estimated 470,000 new cases of cervical cancer each year and 233,000 deaths – making the disease the fifth most deadly cancer in women, partly due to less than ideal HPV screening protocols in many countries.

“Screening is low in some parts of the world because of cultural taboos,” said Andreas Braun, MD, PhD, TrovaGene’s Acting President and CEO. “ Current tests require cervical sampling, and many women will not agree to have this invasive procedure for privacy and other reasons, leading to poor compliance. The TrovaGene test is completely non-invasive, requiring only a urine sample. We believe this will enhance testing and reduce the risks inherent in allowing the HPV virus to go unchecked.”

For example, Segal said India and other regions in Asia have considerably higher rates of cervical cancer incidence compared with the United States, primarily because of lower screening rates.

He said a pilot study in India last year of TrovaGene’s urine-based test among 320 patients showed excellent “sensitivity and specificity” results.

“We believe the TrovaGene screening platform enhances clinical specificity and sensitivity, enhancing the chances for a more accurate and robust result” Segal said.

The TrovaGene urine test could also be particularly helpful in detecting HPV in men, he said.

“What do men do now? For the most part, nothing,” said Segal. “You cannot perform cervical scraping in men. A simple urine sample, however, could pave the way for male screening.”

Currently, there are cervical DNA tests, using samples gained through invasive cervical scrapings, said Segal
“There are at least 13 dangerous subtypes of HPV prone to causing cervical cancer, and the TrovaGene test would detect the presence of one of the types with a very simple, private and non-invasive urine-based DNA test,” he said.

TrovaGene, Inc.,(Trov.PK) is a developer of urine-based molecular diagnostic products based on the detection of transrenal genetic markers. These cell-free nucleic acid fragments pass through the kidney and are detectable in the urine, allowing for the development of genetic testing using simple-to-obtain urine samples rather than the more invasive methods of traditional cervical scrapings or blood testing.

For further information, please contact:

Kerry Segal
Chief Business Officer
TrovaGene, Inc.
(858) 997-2594 (Direct)
ksegal@trovagene.com


Venanzio Ciampa
President
THE PROMOTION FACTORY
5 E. 19th Street, 6th floor
New York, NY 10003
TEL 212 217 9065 | FAX 212 217 9075
venanzio@thepromofact.com

TrovaGene, Inc. (TROV.PK), a publicly traded company based in San Diego, Calif., is dedicated to the development and commercialization of transrenal molecular in-vitro diagnostic products. Formerly known as Xenomics, Inc., TrovaGene (from the Italian root word meaning “to find”) is initially targeting medical conditions in which the standard of care requires samples that are difficult, painful, or dangerous to obtain and analyze as well as conditions for which no diagnostic tests currently exist. These targets include tests for the detection and monitoring of cancers and infectious diseases, prenatal genetic testing, and the monitoring of organ/cell transplants.

The company’s founding scientists were the first to report that cell free fragments of DNA from normal cell death that circulate in the blood can cross the kidney barrier and be detected in urine. The company believes that this transrenal technology will open significant new markets in the molecular diagnostics field and lead to improvements in the area of personalized medicine.

TrovaGene has a dominant patent position as it relates to transrenal molecular testing. It has issued U.S. and European patents that cover any and all testing for molecular targets that pass through the kidney. In addition to these core patents it has numerous patent applications pending in the areas of cancer, infectious diseases, transplantation, prenatal and genetic testing.

TrovaGene, Inc., 11055 Flintkote Ave., Suite B, San Diego, CA. 92121
Contact: Kevin Segal, Chief Business Officer, (858) 997-2594. Ksegal@trovagene.com.
Press Contact: Venanzio Ciampa, President, The Promotion Facatory, 5 E. 19th St., 6th Fl, New York, NY 10003. 212-217-9065. venanzio@thepromofact.com.

This release was published on openPR.