Trovagene, a developer of circulating tumor DNA (ctDNA) molecular diagnostics, announced that it will increase its focus on the global distribution of kits and systems to clinical research laboratories for the liquid biopsy oncology testing market.
Trovagene previously announced a strategic long-term relationship with Boreal Genomics to co-develop urine and blood ctDNA assay kits for next generation sequencing (NGS) platforms.
This partnership allows Trovagene to globally distribute assay kits for use on the Boreal OnTarget™ system in blood and exclusively in urine. Trovagene's initial research-use-only proprietary kits will include a urine collection kit, a urine ctDNA extraction kit and multigene mutation enrichment kits, along with the Boreal OnTarget™ system.
"Numerous clinical research laboratories have expressed significant interest in utilizing our ctDNA technology to offer their own in-house liquid biopsy tests to clinicians and their patients," said Bill Welch, Chief Executive Officer of Trovagene.
"Our transition to marketing kits directly to these clinical research laboratories lowers our commercial costs and mitigates any sales conflicts with our laboratory customers."
Trovagene has completed a reorganization that will allow the company to concentrate on the distribution of kits and systems to be utilized by Research Institutions, Cancer Centers, and clinical service facilities for research use around the world.
Trovagene estimates the program will reduce annual pre-tax expenses by approximately $4.0M per year mainly through the reduction of approximately 20 personnel and expenses linked to marketing CLIA services directly to medical professionals.
Trovagene will continue to operate its CLIA/CAP- certified laboratory to provide and grow its testing services to third party US and international clinical research laboratories and for pharmaceutical drug development.
Headquartered in San Diego, California, Trovagene is leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in an effort to enable itself, and others through the distribution of research use kits and systems, to detect and monitor ctDNA in urine and blood.
The Company's technology allows for detection and quantitation of oncogene mutations in cancer patients for improved disease management.
Trovagene's PCM technology is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.