Urine-Based Cancer Detection Technology Validated

Clinical validation of Trovagene's ultrasensitive assay procedure has been confirmed initially for detection of the BRAF mutation from cell-free (cf)-DNA in urine. The cf-BRAF test will be available as a laboratory-developed test (LDT), offered through the company's clinical laboratory improved amendments (CLIA) lab.

The ability to regularly detect and monitor the results of cancer treatment through a noninvasive, systemic sample could significantly help patients who require therapy for recurrent or metastatic cancer.

"Our ability to detect and quantify oncogenic mutations in the urine of cancer patients represents a significant step towards better patient monitoring," said Mark Erlander, PhD, CFO for Trovagene. The analytic performance levels required to achieve this are made possible through the large sample volumes available from urine, combined with digital polymerase chain reaction (PCR) and sequencing platforms.

Numerous cell-free assays are being developed by Trovagene that target clinically actionable oncogene mutations, including BRAF, KRAS, PIK3CA and others. Several new, targeted therapies have been approved for treatment of BRAF-mutation positive melanoma. Therefore, Trovagene has prioritized the development of the BRAF assay to address the clinical need to monitor patient response to these therapies. BRAF mutations are prevalent in many different cancers. Trovagene's cf-BRAF mutation assay is being validated across a range of solid tumors, confirming that urine-based mutation detection is applicable across many cancer types.

Assay panels are being developed to broaden Trovagene's cancer monitoring capabilities, using next-generation sequencing platforms. Many cancers exhibit multiple oncogenic mutations and genomic variations, and can develop new resistance mutations during the course of disease and treatment. Targeted cancer monitoring panels may provide a cost-effective way of following these patients throughout their disease as compared to current standard-of-care monitoring techniques, which include CT and PET scans.

Trovagene is leveraging its patented technology for the detection of cell-free DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that can be isolated and detected from urine.

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