TrovaGene regains ownership of worldwide rights to transrenal technology

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.

Source: TrovaGene, Inc.