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MDx/CDx Focus: Trovagene, MD Anderson Work to ID KRAS Mutations in Urine; FDA on Device Identifiers


Trovagene, MD Anderson Collaborate to ID KRAS Mutations in Pancreatic Cancer Patients' Urine

Trovagene and the University of Texas MD Anderson Cancer Center will collaborate on a study to detect transrenal KRAS mutations in the urine of patients with pancreatic cancer.

Published studies have reported that KRAS mutations are present in more than 90 percent of pancreatic cancers, as well as in more than 20 percent of all cancer tissue samples in the COSMIC (Catalogue of Somatic Mutations in Cancer) database maintained by the Wellcome Trust Sanger Institute. As previously reported by PGx Reporter sister publication PCR Insider, Trovagene is using Bio-Rad's QX100 Droplet Digital PCR system to develop a non-invasive, urine-based molecular test that can detect and monitor the progression of pancreatic cancer (PCR Insider 5/31/2012).

In addition to detecting KRAS mutations in the urine of patients with pancreatic cancer, researchers in the new study "will also determine the KRAS mutation status from biopsies taken from the same patients," principal investigator Matthew Katz of MD Anderson said in a statement. "This will allow an early comparison of mutation detection using biopsy, which samples only a portion of a tumor, with detection using urine, a systemic sampling of the patient."

If the validation study proves that Trovagene's urine-based molecular test is as accurate as biopsy-based tests, doctors may have a less-invasive method of staging tumors by their molecular profile ahead of treatment initiation and of detecting residual disease post-treatment.

"The volume of urine that can be collected far outstrips what is available by biopsy or even through blood collection; this may significantly improve detection," Charlie Rodi, Trovagene's chief technology officer, said in a statement. "In addition, urine is a truly non-invasive sample that could greatly simplify patient monitoring in the future."

FDA Requiring Unique Identifier Tagging for Medical Devices to Track Safety, Facilitate Recalls

The US Food and Drug Administration this week proposed a rule that medical devices in the US will be tagged with a so-called unique device identifier.

"A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety," the agency said in a statement announcing the proposed rule.

FDA's UDI plans are mandated by a 2007 amendment to the Federal Food, Drug, and Cosmetic Act that directs the agency "to promulgate regulations establishing a unique
device identification system for medical devices."

By tagging medical devices with UDI's the agency is hoping to facilitate more accurate reporting, review, and analysis of adverse events reports; reduce medical errors by allowing healthcare providers to quickly identify a faulty device; enable consistent data reporting about devices in electronic medical records; allow manufacturers to speedily recall devices; and rein in counterfeit products across global distribution chains.

The agency has developed and tested the ability of UDIs to track medical devices in the market in four pilot studies. The public has 120 days to comment on the FDA's proposal.

“The safety of medical devices is a top priority for the FDA, Congress, industry, and patients,” said FDA Commissioner Margaret Hamburg in a statement. “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.”

The FDA is proposing two types of UDIs: a numeric or alphanumeric code specific to a device model and another identifier that describes the production information for a device.

"A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number," the agency explained. "This information will be contained in a publicly available UDI database, and no identifying patient information will be stored in this device information center."

The FDA has indicated that it is planning to require that the highest risk medical devices implement UDI codes first. Low-risk devices, meanwhile, will likely have to meet a limited set of UDI-related requirements. Since most over-the-counter devices have UDI codes already in place, such products stand to be least affected by this requirement.

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