The Company has been developing a urine-based diagnostic that could be more effectively used for screening for bladder cancer in patients presenting with hematuria, confirming indeterminate cytology findings, and diagnosing recurrence of bladder cancer in patients in remission. OncoCyte presented interim clinical study data for the non-invasive detection of bladder cancer at the American Association for Cancer Research (AACR) in April of 2015 demonstrating a high level of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer. At AACR OncoCyte reported a ROC AUC of .91, sensitivity of 90% and specificity of 83%. The study to be presented at ASCOcontinued the development of the diagnostic first reported in the 2015 study.
“ASCO is one of the largest medical meetings of the year and OncoCyte is excited to be presenting clinical data for our diagnostics for the second year in a row,” commented William Annett, Chief Executive Officer. “Our bladder test has the potential to screen approximately four million patients along the cancer spectrum annually and reflects our robust clinical pipeline of diagnostics assays. We are looking forward to sharing our results with the medical community as well as our shareholders.”
The data will be presented by Karen B. Chapman, Ph.D., OncoCyte’s Vice President of Research.
Presentation Title: “Derivation of gene expression classifiers for the non-invasive detection of bladder cancer in the hematuria and recurrence surveillance populations.”
Session Title: Tumor Biology
Poster Session: 1 PM – 4:30 PM June 6, 2016
Poster Discussion Session: 4:45 PM – 6 PM, June 6, 2016
About Bladder Cancer
Bladder cancer has been projected to have the highest lifetime treatment costs per patient of all cancers. Bladder cancer in the U.S. was estimated to cost $125B in 2010, growing to $155B in 2014. The high recurrence rate and ongoing invasive monitoring requirements drive the financial burden of this disease.
About OncoCyte Corporation
OncoCyte is primarily focused on the development and commercialization of novel, non-invasive blood and urine (“liquid biopsy”) diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients.
While current biopsy tests use invasive surgical procedures to provide tissue samples in order to determine if a tumor is benign or malignant, OncoCyte is developing a next generation of diagnostic tests that will be based on liquid biopsies using blood or urine samples. OncoCyte’s pipeline products are intended to be confirmatory diagnostics for detecting lung, bladder and breast cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein markers that differentially express in specific types of cancer.
Forward Looking Statements
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for OncoCyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights, and obtaining third party reimbursement for patients ’use of any diagnostic tests we commercialize. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of OncoCyte, particularly those mentioned in the cautionary statements found in OncoCyte’s Securities and Exchange Commission filings. OncoCyte disclaims any intent or obligation to update these forward-looking statements.
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