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Trovagene closes on CLIA
SAN DIEGO—Trovagene Inc., a developer of transrenal molecular diagnostics, has closed its acquisition of MultiGEN Diagnostics Inc.'s clinical laboratory assets based on an asset acquisition agreement announced earlier this year.
Trovagene claims to have a dominant patent position in the area of 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) and mutations in the sf3b1 gene, which have been shown to be associated with chemotherapy response in chronic lymphocytic leukemia (CLL) patients.
Headquartered in San Diego, Trovagene is developing its patented technology for the detection of transrenal DNA and RNA—short nucleic acid fragments—originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine. Trovagene made the strategic decision to establish a CLIA lab to move its transrenal technologies into clinical tests.
"As part of the 'make-or-buy' decision, we evaluated acquisition opportunities and identified MultiGEN as a very suitable option, suitability defined as proximity and technology overlap," says Dr. Antonius Schuh, Trovagene's CEO.
Acquiring a CLIA facility was a "most enabling event for us," Schuh adds.
"Transrenal nucleic acid sequences are short fragments (20 to 150 mers), and their analytical detection has been cumbersome and expensive," he says. "The introduction of next-gen sequencing, which favors short sequences, digital PCR and the enormous cost reductions seen over the past two years for these detection systems now enables Trovagene to configure diagnostic assays that are streamlined and quite cost-effective. Hence, the company decided to take the step to transition to a commercial organization. The CLIA lab is a critical component here. It is de facto our commercial platform."
In the human body, billions of cells die each day due to tissue and organ maintenance, but also as a result of disease processes. Most of this cellular DNA is degraded into short fragments by specific enzymes. However, a small fraction escapes complete degradation and appears in the bloodstream. Scientists at Trovagene discovered that a portion of this circulating DNA crosses the kidney barrier and can be found in the urine in the form of 150-200 bp fragments. This discovery opens the possibility for the development of new, noninvasive techniques for molecular diagnostics and genetic testing, Schuh explains. The technique is believed to have important potential for various clinical applications, including detection and tracking of cancer gene mutations, non-invasive prenatal testing and infectious disease testing.
"The technique has numerous advantages," Schuh says, "including ease of sampling, no volume restriction and ease of sample shipping due to high stability."
Trovagene was founded in 1999 and has invested approximately $40 million toward the investigation of the phenomenon of transrenal nucleic acids. The company expects its head count—currently eight—and its 8,000 square-foot lab space in San Diego to grow significantly with the transition from an R&D organization to a commercial operation.
MultiGEN will continue to operate as a molecular diagnostics company focused on DNA sequence-based identification services using its IP protected technologies. The company provides Syndrome Driven Panels in a single test that screens for all the pathogens or mutations that can cause a particular syndrome regardless of whether they are bacteria, viruses, fungi or parasites, and also provides same-day reporting to better assist with the timely creation of an optimal treatment regime. MultiGEN's other two groups of applications include developing highly sensitive assays to detect mutations among samples carrying heterogeneous genomes and applications in drug development.