SAN DIEGO--(BUSINESS WIRE)--TrovaGene, Inc. (Pink Sheets: TROV), a developer of transrenal molecular diagnostics, confirmed today that it regained ownership of its worldwide rights and control over its patent estate for transrenal technology for non-invasive prenatal applications and cancer through the termination of a license agreement between TrovaGene and Sequenom, Inc. In 2008, TrovaGene licensed several of its patents to Sequenom for the development of prenatal diagnostic and screening applications on an exclusive basis. In 2009, TrovaGene initiated a lawsuit against Sequenom alleging fraud and demanding the return of its rights licensed to Sequenom.
“We are very pleased that TrovaGene has regained the prenatal development rights to diagnostic products based on our transrenal technology,” commented Dr. Thomas Adams, TrovaGene’s Chairman. “This gives us the opportunity to expand our business in the women’s healthcare market beyond our advanced HPV screening program based on urine samples, which can be obtained non-invasively and in complete privacy.”
Recently, TrovaGene has generated data by next-generation sequencing that unambiguously demonstrated the plurality and genomic representation of fetal transrenal sequences in urine from pregnant women. TrovaGene believes that a urine sample is a superior specimen compared to plasma with regard to its simplicity of collecting, shipping and analyzing for certain fetal conditions including aneuploidies (e.g. Down Syndrome). TrovaGene has initiated partnering discussions with several companies, whose analytical technologies are synergistic to short transrenal DNA fragments in urine, complementing its proprietary nucleic acid extraction and processing methodologies.
In the U.S. there are more than 4 million pregnancies per year, representing a significant multi-billion dollar business opportunity for non-invasive and, therefore, risk-free ante-natal screening tests. Currently, there are several American and European companies in the process of launching tests for Down Syndrome and other aneuploidies based on massively parallel sequencing. However, none of those companies control rights to the sequencing technology they employ which makes them dependent on only a couple of technology providers and renders regulatory pathways more complicated. In addition, sequencing is still costly and the analytical process exhibits several shortcomings regarding sample throughput and ultimately turnaround time.
“Encouraged by our sequencing data we believe the right combination of analytical technologies merged with the enriched source of transrenal DNA fragments in urine allows us to be extraordinarily competitive within this prenatal screening market in terms of cost and time to result while maintaining high clinical sensitivity and specificity,” said David Robbins, Vice President, Research and Development.
About TrovaGene, Inc.
Headquartered in San Diego, California, TrovaGene has focused on development of tests using its patented technology to detect transrenal DNA and RNA, short nucleic acid fragments from normal and diseased cell death that cross the kidney barrier and can be detected in urine. The safe and completely non-invasive nature of obtaining a urine sample increases patients’ compliance to screening procedures and enables at-home sample collection while protecting privacy. TrovaGene’s key corporate objective is the development of molecular diagnostic screening products using its proprietary technologies that will significantly improve women’s healthcare.
TrovaGene has a dominant patent position as relates to transrenal molecular testing. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myeloid leukemia (AML).
TrovaGene is currently in the process of auditing its financial statements and preparing a Form 10 registration statement so that it can report on a current basis with the Securities and Exchange Commission. A filing is anticipated during the third quarter of 2011. More complete current information about TrovaGene will be contained in the filing.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on TrovaGene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. TrovaGene does not undertake an obligation to update or revise any forward-looking statement.