TrovaGene Cancer Technology Detects KRAS Mutation

TrovaGene, Inc. (TROV) recently unveiled clinical study results that reflect the capability of its Precision Cancer Monitoring technology in detecting and monitoring KRAS mutation in circulating tumor DNA (ctDNA).

The study compared the amount of ctDNA present in plasma, urine and tissue samples of patients suffering from advanced colorectal cancer. Trovagene used its KRAS mutation assay technology to analyze these samples.

The study showed that relationship between the changes in quantity of mutational cells in all the samples is highly correlated. Of the plasma and urine samples evaluated, 95% and 92%, respectively, displayed features similar to tumor tissues. The correlation between urine and plasma was also significantly high at 94%.

KRAS gene mutations are quite common in pancreatic, lung, and colorectal cancers. A high level of KRAS mutation suggests that EGFR-inhibiting drugs, such as cetuximab (Erbitux) and panitumumab (Vectibix), will not be effective in treating colorectal cancer. Hence, monitoring of KRAS mutation in colorectal cancer patients is of utmost importance to determine the right course of treatment.

TrovaGene expects to release additional clinical data related to KRAS mutation study in mid-2015. The company’s assay technology has already portrayed its ability in monitoring patients with BRAF gene mutations that are found in skin, colon and rectum, ovary and thyroid gland. We believe the addition of KRAS mutation monitoring capability will boost patient base for TrovaGene in the long run.

Currently, TrovaGene is involved in a number of development programs for cancer monitoring applications related to pancreatic, melanoma (advanced skin cancer), colorectal and lung cancer. The company is also engaged in a number of clinical studies in the near term (more than 10 in 2015). TrovaGene’s growing relationship with leading cancer centers (top 20) serves as a key catalyst for top-line growth over the long term.

We believe TrovaGene has strong growth potential from geographic expansions, partnerships and kit manufacturing. Based on its urine-based High Risk Human Papillomavirus (:HPV) Assay technology solution, the company holds significant growth prospects in the HPV testing market that is forecasted to be worth $9 billion by 2020.

TrovaGene’s growing patent portfolio is also a key growth catalyst, in our view. However, the company’s recent third quarter results have disappointed us. Moreover, we believe that higher investment in research & development will continue to negatively impact the company’s profitability in the near term.

Zacks Rank

TrovaGene presently has a Zacks Rank #3 (Hold).

Better-ranked stocks in the industry include Affymetrix (AFFX), AMAG Pharmaceuticals, Inc. (AMAG) and ANI Pharmaceuticals, Inc. (ANIP). All the stocks carry a Zacks Rank #1 (Strong Buy).

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