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Trovagene to Launch Analytical Validation Program for Trans-Renal KRAS Mutation Assay

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Originally published May 2. Updated May 3 to include additional details of Trovagene's product commercialization plans.

Trovagene is planning to launch an analytical validation program mid-year for its trans-renal KRAS mutation detection assay to assess its ability to gauge markers in urine samples from pancreatic cancer patients.

Based on published literature, KRAS mutations have been implicated in more than 90 percent of pancreatic cancers and in 23 percent of solid tumors. San Diego-based Trovagene is hoping that a urine-based trans-renal KRAS assay, if successfully developed, could potentially help doctors diagnose and monitor pancreatic cancer progression.

"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," Antonius Schuh, Trovagene's CEO, said in a statement. "Clinical utility of and clinical need for such a platform would be highly significant."

There is a growing body of evidence showing that testing for KRAS mutations may facilitate earlier diagnosis of pancreatic cancer.

Research recently published in the Proceedings of the National Academy of Sciences by a team led by Bert Vogelstein of Johns Hopkins University found that mutations in KRAS and GNAS genes occur frequently in pancreatic cancer patients. Investigators in this study used mass spectrometry to analyze the presence of KRAS and GNAS mutations in patients' tumor tissue and pre-malignant pancreatic cyst fluids. The JHU researchers are now planning to develop a genetic test to help distinguish which pre-malignant pancreatic cysts harboring KRAS mutations have the potential to develop into cancer and which cysts are harmless.

Trovagene would not discuss with PGx Reporter the downstream clinical applications for the trans-renal KRAS assay, but said that analyzing urine samples from pancreatic patients provided a test case for establishing the analytical features of the assay. Trovagene further highlighted that in a myriad of cancer settings urine-based mutation analysis could provide a less invasive method of characterizing the molecular profile of a tumor than tumor biopsy and provide an alternative strategy when biopsy wasn't possible.

The KRAS mutation assay will operate on a digital PCR platform. According to Trovagene, the company has purchased "off-the-shelf" digital PCR technology but did not identify the vendor.

Digital PCR may offer a more sensitive analysis over traditional PCR analysis by separating each sample into different sections and simultaneously quantifying nucleic acids.

There are a number of labs that currently offer PCR-based KRAS testing for a range of conditions, including pancreatic and lung cancer, Noonan syndrome, and cardiofaciocutaneous syndrome.

KRAS testing is also performed to guide treatment with EGFR inhibitors in colorectal cancer. The US Food and Drug Administration has updated the label for the colorectal cancer drugs Vectibix and Erbitux, recommending that only patients with wild-type KRAS tumors receive the drug.

Qiagen markets a PCR-based KRAS test and is in the process of garnering FDA approval for this assay for use as a companion diagnostic with Vectibix and Erbitux.

Urine Based HPV Test

Separately, Trovagene announced this week that it plans to commercialize a diagnostic test later this year that determines the presence of high-risk HPV subtypes in urine samples. The US patent application related to this test is currently pending, according to Trovagene.

"Once available, [the HPV test might] be particularly useful for the determination of carrier status in males," the company said in a statement. The test works by amplifying a region of the HPV genome associated with high-risk subtypes of the disease, but doesn't amplify the low-risk regions.

In a study, Trovagene compared the analytical validity of its urine-based diagnostic to a marketed HPV test and resolved the discordant results by Sanger sequencing. The data show that Trovagene's assay had a sensitivity of 93 percent and a specificity of 96 percent, while the commercially available liquid-based cytology test had a sensitivity of 78 percent and a specificity of 86 percent.

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