On May 19, 2016 OncoCyte Corporation (NYSE MKT: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported the abstract of data from a bladder cancer study that will be presented as a poster and also highlighted during a live panel discussion on June 6, 2016, during the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in Chicago, Illinois (Press release, BioTime, MAY 19, 2016, View Source [SID:1234512597]).
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"Our bladder test results are highly encouraging and reflect the depth of quality diagnostics products in our robust pipeline," commented OncoCyte Chief Executive Officer William Annett. "There is a high unmet need for non-invasive tests for bladder cancer and our gene expression classifiers have been shown to provide superior sensitivity in a procedure that is less invasive to patients than the current standard of care. Our results indicate the feasibility of using a urine-based diagnostic test to detect urothelial carcinoma both in screening (hematuria) and recurrence settings."
The abstract entitled Derivation of Gene Expression Classifiers for the Non-invasive Detection of Bladder Cancer in the Hematuria and Recurrence Surveillance Populations, describes OncoCyte’s recent results in the development of a urine-based test for bladder cancer. The detection of bladder cancer is typically accomplished with a combination of cystoscopy and urine cytology, each with inherent limitations. Urine cytology lacks the desired level of sensitivity, whereas cystoscopy is relatively invasive for routine screening and recurrence surveillance. OncoCyte’s study describes the development of four gene expression classifiers (GECs) optimized for the non-invasive detection of both high-grade and low-grade urothelial carcinoma in patients presenting with hematuria or for bladder cancer recurrence surveillance. The results for high-grade screening, high-grade recurrence, low-grade screening and low-grade recurrence were all obtained from single urine samples utilizing four different algorithms. A multi-center study involving 241 patient urine samples was used in the development of this assay.
OncoCyte’s approach of sequential GECs optimized for the detection of high-grade and low-grade malignancies provides the necessary data to distinguish between these different types of lesions and benign conditions in a non-invasive manner. Low-grade urothelial carcinoma is usually a non-aggressive cancer, whereas high-grade urothelial carcinoma is more aggressive, invasive and causes significantly more cancer-related mortality than low-grade urothelial carcinoma.
The GEC optimized for the detection of high-grade urothelial carcinoma in patients presenting with hematuria performed, with a cross-validated ROC AUC of 0.93, while the low-grade performed with an AUC of 0.81. In the recurrence surveillance cohort, the detection of high-grade performed with an AUC of 0.81 and low-grade with an AUC of 0.64. The following table summarizes these results.
ROC AUCs
Low Grade High Grade
Screening (Hematuria) 0.81 0.93
Recurrence 0.64 0.81
"These data establishes the feasibility of our approach, and we look forward to continuing our larger, multicenter study to further validate these findings," added Karen B. Chapman, Ph.D., OncoCyte’s Vice President of Research, who led the study.
About Bladder Cancer
Bladder cancer has been projected to have the highest lifetime treatment costs per patient of all cancers. The high recurrence rate and ongoing invasive monitoring requirements drive the financial burden of this disease. The detection of bladder cancer in Hematuria and Recurrence patients is routinely accomplished with a combination of urine cytology and cystoscopy which is invasive, and lacks the desired level of sensitivity.