ALAMEDA, Calif., Oct. 17, 2016 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood-based tests for the early detection of cancer, and The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, announced a summary of the data that will be presented at the American College of Chest Physician’s CHEST 2016 Annual Meeting, which will be held October 22-26 in Los Angeles. The data will be presented by lead investigator Louise Showe, Ph.D., professor in the Molecular and Cellular Oncogenesis Program and associate director for the Center for Systems and Computational Biology at The Wistar Institute.
The study demonstrates the ability of a lung cancer diagnostic to distinguish malignant from benign lung growths based on previously identified gene expression signatures, co-developed by Wistar and OncoCyte, under a license from Wistar.
The study, A Blood Based Non-Small Cell Lung Cancer Diagnostic, was conducted at Wistar and analyzed 610 human blood samples based on nodule sizes from 3 mm to 42 mm that were derived from six collection sites. The data suggest that it is possible to distinguish malignant from benign lung growths based on the gene expression signature, and that the classifier can also provide a preliminary stratification of patients by nodule size and thus cancer risk. This non-invasive test can potentially differentiate between those patients with benign nodules and those in need of further testing by follow up Low Dose Computed Tomography (LDCT), bronchoscopy or biopsy.
Using all 610 samples, without accounting for nodule size, the biomarker study derived a sensitivity of 90% and specificity of 46%. However, specificity changed as a function of nodule size, with smaller nodules having higher specificity; consequently, using only nodules less than 10 mm in size (median 6mm), sensitivity was 90% and specificity 54%.
In addition, including nodule size in the classifier algorithm increased the diagnostic test’s accuracy significantly. Using both biomarker and nodule size data for all samples gave sensitivity of 90% and specificity of 80.7%.
“I look forward to presenting our latest data at CHEST as we are on the cusp of creating a lung cancer diagnostic for the early detection of lung cancer,” said Showe. “The partnership with OncoCyte has been critical to moving our research forward and demonstrates the limitless potential in scientific collaboration.”
“CHEST is a prestigious event, and it represents a perfect forum for The Wistar Institute to present this important data about its latest study on the lung cancer diagnostic,” commented William Annett, Chief Executive Officer of OncoCyte. “We are taking the project to the next phase by carrying out our own study based on Wistar’s encouraging findings and expect to complete our study later this year. Wistar’s finding that nodule size data combined with biomarker results significantly increases the accuracy of the diagnostic test is an important development, and we will be evaluating nodule size and the test's performance in our study and algorithm.”
OncoCyte expects that its study results will be available during the fourth quarter of 2016. If the study is successful, OncoCyte plans to apply to the State of California for CLIA certification of its laboratory in the first quarter of 2017 and then conduct a smaller CLIA lab study of the diagnostic test to ensure that the findings are replicated in an operational setting. Assuming successful CLIA certification and replication, OncoCyte plans to launch its lung cancer diagnostic test in the second quarter of 2017.
About Lung Cancer
Lung cancer is the leading cancer killer of both men and women in the United States. Lung cancer is the leading cause of cancer deaths worldwide, accounting for 1.8 million new cases and 1.6 million deaths annually. An estimated 159,040 Americans will die from lung cancer in 2015, accounting for approximately 27 percent of all cancer deaths. It also has one of the lowest five-year survival rates of all cancer types. The National Institutes of Health estimates that lung cancer care cost the U.S. $13.1 billion in 2014.
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.
About The Wistar Institute
The Wistar Institute is an international leader in biomedical research with special expertise in cancer, immunology, infectious diseases, and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the United States, Wistar has held the prestigious National Cancer Institute Cancer Center designation since 1972. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. Wistar’s Business Development team is dedicated to advancing Wistar Science and Technology Development through creative partnerships. wistar.org
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” and similar expressions) should also be considered to be forward-looking statements. These statements include those pertaining to the implementation and results of our validation study and other studies, commercialization plans, 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. 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, the need and ability to obtain future capital, and maintenance of intellectual property rights, and the need to obtain third party reimbursement for patient’s 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 “Risk Factors” and other cautionary statements found in OncoCyte’s Securities and Exchange Commission filings. OncoCyte disclaims any intent or obligation to update these forward-looking statements, except as required by law.
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