Company Update (NASDAQ:TROV): TrovaGene Inc’s Urine-Based Liquid Biopsy Platform Shows Clinical Sensitivity of 93 Percent in Lung Cancer Study

TrovaGene Inc (NASDAQ:TROV), a developer of cell-free molecular diagnostics, today announced the presentation of clinical data featuring the use of its Precision Cancer Monitoring℠ (PCM) platform for the quantitative detection and monitoring of EGFR T790Mmutations in patients diagnosed with non-small cell lung cancer. Dr. Shirish Gadgeel, Karmanos Cancer Institute in Detroit, a NCI-designated comprehensive cancer center, is the lead author on data that will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on November 6, 2015 in Boston, MA. The data are an exploratory analysis of 63 patients from a Phase I/II study of rociletinib, a 3rd generationEGFR inhibitor being developed by Clovis Oncology for the treatment of EGFR-mutant non-small cell lung cancer (NCT01526928).

“We have demonstrated, in multiple clinical studies, our ability to identify and track oncogene mutations that are known to drive melanoma, lung, colorectal, and pancreatic cancers,” stated Antonius Schuh, Ph.D., chief executive officer of Trovagene. “In this interim data set, we observe greater than 90% clinical sensitivity vs. tissue biopsy when urine samples are submitted within our specified acceptance criteria. The data also demonstrate that collecting higher sample volumes and obtaining more input DNA significantly improves clinical sensitivity, an important advantage of our PCM platform and its urine-based application. We are pleased by this interim data and look forward to continuing to build the body of clinical evidence supporting our liquid biopsy solution for cancer monitoring.”

Abstract title:  Assessment of EGFR mutations in matched urine, plasma and tumor tissue in NSCLC patients treated with rociletinib (CO-1686)

  • Abstract No. A31
  • Presentation type: Poster Session A; Biomarkers
  • Presentation date/time:  Friday, November 6, 2015 / 12:15 p.m. to 3:15 p.m. EST

The interim analysis includes urine samples collected from 63 patients with sample volumes ranging from 8 to 100 ml. 45 of 63 non-small cell lung cancer patients (71%) were positive for T790M by urine testing in comparison to 47 of 63 (75%) by central lab testing of tissue. However, for analyzed samples within Trovagene’s stated acceptance criteria, between 90 ml and 110 ml of urine (approximately 3 – 4 oz.), the positive percent agreement (PPA) between urine and tumor T790M test results was 93% (13 of 14). In addition, in the full data set, regardless of urine volumes submitted, 13 cases were tumor T790M+/urineT790M-, and seven cases were urine T790M+/tumor T790M-. These data indicate that a combination of tissue and urine-based testing identified more T790M-positive patients than tissue alone.

“The study data are consistent with my early clinical experience with Trovagene’s technology. After testing a patient twice using tissue biopsy, the information on progression was inconclusive, despite my suspicion of the emergence of the EGFR T790M mutation,” stated David Berz, M.D., Ph.D., M.P.H., a clinical oncologist at the Beverly Hills Cancer Center. “Under the Company’s Clinical Experience Program, I ordered Trovagene’s urinary liquid biopsy test, which detected the emergent mutation in relatively high abundance. This result enabled me to identify a new targeted treatment option for this patient. I’m encouraged by my experience with Trovagene’s technology, and will continue to use it in my practice.”

Trovagene is currently conducting numerous clinical studies to demonstrate the performance and clinical utility of its Precision Cancer Monitoring platform for the detection and monitoring of activating and emergent EGFR mutations in non-small cell lung cancer patients. Results from several of these studies are anticipated to be reported and presented throughout 2016. (Original Source)

Shares of TrovaGene closed yesterday at $4.80. TROV has a 1-year high of $13.58 and a 1-year low of $4.02. The stock’s 50-day moving average is $5.80 and its 200-day moving average is $8.19.

On the ratings front, TrovaGene has been the subject of a number of recent research reports. In a report issued on September 22, Maxim Group analyst Jason Kolbert reiterated a Buy rating on TROV, with a price target of $13, which implies an upside of 170.8% from current levels. Separately, on September 15, Cantor Fitzgerald’s Bryan Brokmeier initiated coverage with a Buy rating on the stock and has a price target of $10.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Bryan Brokmeier have a total average return of -15.6% and 3.5% respectively. Kolbert has a success rate of 28.3% and is ranked #3797 out of 3802 analysts, while Brokmeier has a success rate of 55.0% and is ranked #1410.

TrovaGene Inc is a development stage molecular diagnostic company. It focuses on the development and marketing of urine-based nucleic acid tests for patient/disease screening and monitoring.

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