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U.S. Trovagene, Inc. has announced that results emerging from ongoing clinical studies have confirmed the broad applicability of Trovagene technology across a variety of cancer types, and the successful development of a molecular diagnostic test capable of detecting and quantifying oncogene mutations from a simple urine specimen.

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

Clinical validation of Trovagene’s ultra-sensitive 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) this quarter, and offered through the company’s CLIA lab.

“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, Ph.D., chief scientific officer for Trovagene. “The analytic performance levels required to achieve this are made possible through the large sample volumes available from urine, combined with state-of-the-art digital PCR and sequencing platforms.”

Trovagene is developing numerous cell-free assays that target clinically actionable oncogene mutations, including BRAF, KRAS, PIK3CA and others. Given the recent approval of several new targeted therapies to treat BRAF-mutation positive melanoma, Trovagene 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.

Building on this ability to detect single mutations, Trovagene is now developing assay panels to broaden its 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.

“Measuring the genomic changes underlying a patients’ tumor can result in clinically actionable information that benefits the patient and the treating physician,” stated Antonius Schuh, Ph.D., chief executive officer of Trovagene. “The additional capability to non-invasively monitor a patients’ cancer in near-real time may improve the overall management of cancer, leading to better patient outcomes.”