Fetal DNA in maternal urine is expected to facilitate development of fast and sensitive diagnostics.

TrovaGene has regained from Sequenom all rights to prenatal applications of its transrenal molecular diagnostics technology. Sequenom negotiated its license to the TrovaGene IP for use in prenatal applications back in 2008, but in 2009 TrovaGene initiated a lawsuit against the firm alleging fraud and requesting the return of its patent rights.  

TrovaGene’s molecular diagnostics platform is based on the detection of nucleic acids in urine. The firm says the reacquisition of rights to prenatal applications will allow it to expand its product development programs beyond its lead HPV screening platform to include prenatal diagnosis of conditions such as Down Syndrome. According to TrovaGene, its recently generated next-generation sequencing studies have confirmed the presence of fetal DNA in the urine of pregnant women.

“Encouraged by our sequencing data, we believe the right combination of analytical technologies merged with 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,” states David Robbins, TrovaGene’s vp for R&D.

TrovaGene is leverating its transrenal molecular diagnostics platform to develop in vitro tests for a range of diseases. Proof of principle studies have already been completed in areas including cancer detection and monitoring, infectious disease testing, organ transplant rejection monitoring, and noninvasive prenatal genetic testing.

The firm is initially focusing on infectious disease testing, with a primary focus on HPV testing and a follow-on program centered on screening for and monitoring opportunistic viral, bacterial, and fungal infections in immunosuppressed patients. In the longer term, the firm aims to develop urine-based assays to detect gene mutations or signature profiles associated with a range of cancers.

TrovaGene has already completed a pilot clinical study with a urine-based HPV DNA test, and is pushing on with a clinical validation study to allow submission of the test for commercialization in Europe. The firm is looking for partners to exploit the technology both for IVD and companion diagnostic development, and for use in clinical trial patient selection and stratification.  

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