NEW YORK – Trovagene, Inc., a developer of transrenal molecular diagnostics, is accelerating its cancer detection program and expects to have a series of clinical studies on “the most prevalent KRAS mutation tests” underway by the end of the year.
“We’re moving very quickly with the clinical validation of these assays,” said Trovagene CEO Antonius Schuh, Ph.D.
The molecular diagnostics company (NASDAQ: TROV) based in San Diego previously announced details of the first of these studies for the detection of transrenal KRAS mutations in urine of patients with pancreatic cancer, in collaboration with The University of Texas MD Anderson Cancer Center.
“We expect that by year-end we will also have initial data about whether the mutational status of a patient or the change in mutational status is prognostic of an event, for the recurrence or for transition from stable disease to aggressive disease,” Schuh said.
He made the comments in a presentation (September 10, 2012) to the 14th Annual Rodman & Renshaw Healthcare Conference at the Waldorf Astoria Hotel in New York City. The entire presentation is available through the investor relations page at www.trovagene.com, “In the fourth quarter this year, we will launch the three most prevalent KRAS mutation tests,” Schuh said.
He said the objective is to “expand into other cancer types and into other mutations” with the eventual “rollout of the additional products.”
The company will announce details of these studies as they are launched. Schuh said the company is focusing on oncology and the rollout oncogene mutation tests through Trovagene’s CLIA lab, and that the easily available sample volume of urine is a key factor in detecting cancer early.
“If you are not allowed to investigate a needle in the haystack, the odds are stacked against you when you want to find the needle,” he said. Making sure that a sample is accurate with blood requires drawing up to five ounces of blood as many as three times a day from a patient after surgery, he said.
“Blood samples are prohibitively large for mutation detection,” said Schuh, but that with urine, a large sample can be obtained “very easily.” Urine, added Schuh, can be “shipped around the country in a Fed Ex pouch” without the need for temperature control or pre-treatment because of its stability. In addition, sample collection does not require a medical professional – it can be done in a patient’s home.
Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine. Trovagene is leveraging its intellectual property in oncogene mutations via out-licensing and use of its transrenal technologies to extend oncogene mutation detection using urine as a sample.
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