Trovagene closes on CLIA

Company completes acquisition of MultiGEN Diagnostics’ clinical laboratory assets

Lloyd Dunlap
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SAN DIEGO—Trovagene Inc., a developer of transrenalmolecular diagnostics, has closed its acquisition of MultiGEN DiagnosticsInc.'s clinical laboratory assets based on an asset acquisition agreementannounced earlier this year.
Trovagene claims to have a dominant patent position in thearea of transrenal molecular testing. It has U.S. and European patentapplications and issued patents that cover testing for HPV and other infectiousdiseases, cancer, transplantation, prenatal and genetic testing. In addition,it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarkerfor acute myeloid leukemia (AML) and mutations in the sf3b1 gene, which havebeen shown to be associated with chemotherapy response in chronic lymphocyticleukemia (CLL) patients.
Headquartered in San Diego, Trovagene is developing itspatented technology for the detection of transrenal DNA and RNA—short nucleicacid fragments—originating from normal and diseased cell death that cross thekidney barrier and can be detected in urine. Trovagene made the strategicdecision to establish a CLIA lab to move its transrenal technologies intoclinical tests.
"As part of the 'make-or-buy' decision, we evaluatedacquisition opportunities and identified MultiGEN as a very suitable option,suitability defined as proximity and technology overlap," says Dr. AntoniusSchuh, Trovagene's CEO.
Acquiring a CLIA facility was a "most enabling event forus," Schuh adds.
"Transrenal nucleic acid sequences are short fragments (20to 150 mers), and their analytical detection has been cumbersome andexpensive," he says. "The introduction of next-gen sequencing, which favorsshort sequences, digital PCR and the enormous cost reductions seen over thepast two years for these detection systems now enables Trovagene to configurediagnostic assays that are streamlined and quite cost-effective. Hence, thecompany 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 totissue and organ maintenance, but also as a result of disease processes. Mostof this cellular DNA is degraded into short fragments by specific enzymes.However, a small fraction escapes complete degradation and appears in thebloodstream. Scientists at Trovagene discovered that a portion of thiscirculating DNA crosses the kidney barrier and can be found in the urine in theform of 150-200 bp fragments. This discovery opens the possibility for thedevelopment of new, noninvasive techniques for molecular diagnostics andgenetic testing, Schuh explains. The technique is believed to have importantpotential for various clinical applications, including detection and trackingof cancer gene mutations, non-invasive prenatal testing and infectious diseasetesting.
"The technique has numerous advantages," Schuh says,"including ease of sampling, no volume restriction and ease of sample shippingdue to high stability."
Trovagene was founded in 1999 and has invested approximately$40 million toward the investigation of the phenomenon of transrenal nucleicacids. The company expects its head count—currently eight—and its 8,000square-foot lab space in San Diego to grow significantly with the transitionfrom an R&D organization to a commercial operation.
MultiGEN will continue to operate as a molecular diagnosticscompany focused on DNA sequence-based identification services using its IPprotected technologies. The company provides Syndrome Driven Panels in a singletest that screens for all the pathogens or mutations that can cause aparticular syndrome regardless of whether they are bacteria, viruses, fungi orparasites, and also provides same-day reporting to better assist with thetimely creation of an optimal treatment regime. MultiGEN's other two groups ofapplications include developing highly sensitive assays to detect mutationsamong samples carrying heterogeneous genomes and applications in drugdevelopment.

Lloyd Dunlap

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