Trovagene this week said that it has completed development of its first molecular diagnostic, a transrenal assay for detecting KRAS mutations, and expects to transfer the assay to its CLIA lab next month and offer the test commercially in January.
Trovagene's test will use Bio-Rad's QX100 Droplet Digital PCR system to detect the most prevalent cancer-related KRAS mutations in cell-free nucleic acids from patient urine samples in order to monitor the progression of pancreatic cancer.
Cell-free nucleic acids originate from both normal and diseased cells, circulate through the bloodstream, cross the kidney barrier, and can be detected in urine as transrenal DNA, Trovagene said.
Trovagene said that it is working with multiple partners to develop a series of transrenal molecular diagnostic tests to detect and monitor cancer mutations. Besides KRAS, the company will initially target BRAF and PIK3CA. Potential uses of these assays include monitoring for recurrence of disease, determining response to therapy, and disease detection.
"Over the next six months, we plan to introduce a variety of assays that may offer significant clinical benefits for physicians and patients, as well as potential savings for the healthcare system," Trovagene CEO Antonius Schuh said in a statement. "The ability to test, detect, and confirm cancer mutation status non-invasively represents an enabling technology that can be used across a variety of clinical applications."
It is unclear whether Trovagene will use Bio-Rad's digital PCR system for all future test development. However, in May Schuh told PCR Insider that it would be offering its KRAS assay on the QX100 Droplet Digital out of its San Diego-based CLIA-certified laboratory, which Trovagene acquired from MultiGen Diagnostics earlier this year (PCR Insider, 5/31/2012).
The QX100 is currently for research use only, but Trovagene can offer its assay as a laboratory-developed test as long as it validates the system within an analytical setup for use within a CLIA lab.
Schuh noted the QX100's sensitivity, cost, easy translation from existing PCR workflows, and robustness as key factors in Trovagene's decision to use the platform for its mutation-detection assay program.