Trovagene announces validation programme for trans-renal K-RAS mutation detection in pancreatic cancer


On 30 April, Trovagene announced that it has successfully completed the analytical development of digital PCR assays for the detection of the most prevalent K-RAS mutations, which are, according to recent estimates, observed in more than 90% of pancreatic cancers(1–3), and in 23% of all solid tumours(4). The company intends to establish and validate the performance of these assays for the detection of K-RAS mutations in the urine of pancreatic cancer patients.

Earlier published work by scientific collaborators of the company (5–8) has demonstrated that K-RAS mutations can be more reliably detected in urine, when compared to plasma or biopsy material. Next generation digital PCR platforms now enable the design of oncogene mutation assays which are compatible with the throughput and reliability requirements of a clinical-diagnostic laboratory at acceptable cost levels.

“The ability to detect K-RAS mutations in urine holds the promise of a non-invasive method for the early detection of pancreatic cancer, which is currently not available to clinicians and patients,” said Riccardo Dalla-Favera, director of the Institute of Cancer Genetics at Columbia University Medical Center and a member of Trovagene’s Scientific Advisory Board.

“The detection of oncogene mutations from urine could eventually lead to a comprehensive platform for monitoring minimal residual disease and progression of disease in oncology, and also for the early detection of cancer,” said Antonius Schuh, CEO, Trovagene. “Clinical utility of and clinical need for such a platform would be highly significant,” he added.

The Company plans to enter into collaborative agreements, providing access to patient samples, with leading endocrine oncology clinical sites in the USA by June 2012.


1. Almoguera C, Shibata D, Forrester K, et al. Most human carcinomas of the exocrine pancreas contain mutant c-K-ras genes (1998) Cell 53: 549-554.

2. Smit V, Boot A, Smits A, et al. KRAS codon 12 mutations occur very frequently in pancreatic adenocarcinomas(1988) NAR  16(16): 7773-7782.

3. Zhang C, Guo W, Wu J, et al. Differential high-resolution melting analysis for the detection of K-ras codons 12 and 13 mutations in pancreatic cancer (2011) Pancreas 40(8): 1283-1288.

4. Prevalence of KRAS mutations in various cancers. Sanger COSMIC site.

 5. Serdyuk OI, Botezatu IV, Shelepov VP, et al. Detection of mutant k-ras sequences in the urine of cancer patients (2001) Bull Exp Biol Med. 131(3):283-284.

6. Su YH, Wang M, Brenner DE, et al. Human urine contains small, 150 to 250 nucleotide-sized, soluble DNA derived from the circulation and may be useful in the detection of colorectal cancer (2004) J Mol Diagn. 6(2):101-107.

7. Su YH, Wang M, Aiamkitsumrit B, et al. Detection of a K-ras mutation in urine of patients with colorectal cancer (2005) Cancer Biomark. 1(2-3): 177-182.

8. Su YH, Wang M, Brenner DE, et al. Detection of mutated K-ras DNA in urine, plasma, and serum of patients with colorectal carcinoma or adenomatous polyps (2008) Ann N Y Acad. Sci. 1137: 197-206.