Trovagene, Inc., has presented the results of a clinical study during the 2015 Gastrointestinal Cancer Symposium held in San Francisco, CA, showing the efficacy of the company’s Precision Cancer Monitoring platform in the detection and quantification of KRAS mutations during diagnosis, using cell-free DNA (cfDNA) from colorectal cancer patients.
Previous trials developed by Trovagene used plasma and urine samples from untreated, advanced colorectal cancer patients that tested positive for known KRAS mutations. Trovagene’s quantitative KRAS mutation assay was used to analyze the samples and evaluate the status of KRAS mutations in urine, blood, and tissue samples, showing that there was a high correlation between the assay’s outcome and tumor mutational status.
Trovagene’s technology can detect cell-free DNA in cancer patients’ urine to improve disease management. This technology can provide crucial clinical data with the potential to improve current treatment strategies.
In their study, titled “Highly sensitive quantitative detection of circulating tumor DNA in urine and plasma from advanced colorectal cancer patients in aid of early diagnosis of clinically relevant KRAS mutations”, researchers analyzed plasma and urine samples that were obtained 3 to 5 years before tumor DNA extraction, from a total of 20 Stage I-IV colorectal cancer patients with KRAS mutations in tumor tissue. Most patients had surgery for primary tumor or liver metastases resection, and had received adjuvant therapy. Trovagene’s Precision Cancer Monitoring was used to quantify KRAS mutations in urine, blood and tissue samples, and to evaluate KRAS burden during therapy.
The results demonstrated that there was a significant correlation between KRAS mutations’ detection in plasma and tissue samples and also urine and tissue samples. Furthermore, alterations in KRAS mutational status was also linked to surgical and chemotherapeutic treatment.
“By tracking the mutational status of advanced colorectal cancer patients post-surgery, clinicians can rapidly determine the surgery outcome and monitor the effectiveness of a subsequent therapy,” study investigator, Lucie Benesova, Ph.D., science director at the Center for Applied Genomics of Solid Tumors, Genomac Research Institute in Prague, Czech Republic, said in a press release. “Trovagene’s assay has potential to provide this information, which can be critical in selecting the best follow up care for patients that have undergone this procedure.”