Molecular Diagnostic Test Detects Transrenal Cancer Mutations

The first molecular diagnostic test capable of detecting genetic mutations from a urine specimen has been successfully developed.

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.

The initial oncogene mutation tests will include V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), V-raf murine sarcoma viral oncogene homolog B1 (BRAF) and phosphatidylinositol 3-kinase (PIK3CA). Potential uses of this noninvasive technology include monitoring for recurrence of disease, determining response to therapy, and disease detection.

The transrenal molecular diagnostic tests have been developed by Trovagene, Inc. (San Diego, CA, USA) and transfer of the transrenal KRAS test to the company’s Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is expected to be completed in December 2012 with commercial availability expected in January 2013.

Solid tumors represent more than 90% of all cancers, and approximately 24% of these are KRAS mutation positive. Based on current cancer incidence rates in the USA, each year an estimated 360,000 newly diagnosed patients are expected to have KRAS mutation-positive cancers.

Charlie Rodi, PhD, chief technology officer of Trovagene, added, “Our scientific team has developed the first commercially viable process for quantitative detection of KRAS mutations in transrenal DNA isolated from a simple urine specimen. This represents a breakthrough in cancer monitoring, and will provide oncologists and surgeons with the ability to frequently check mutation status before, during, and after therapy.”

Antonius Schuh, PhD, chief executive officer of Trovagene, said “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. The ability to test, detect, and confirm cancer mutation status noninvasively represents an enabling technology that can be used across a variety of clinical applications.”

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Trovagene Inc.