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05/21/2019 | Press release | Distributed by Public on 05/21/2019 13:51

OncoCyte Reports Results From R&D Validation Study of DetermaVu™ at the American Thoracic Society 2019 International Conference

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OncoCyte Reports Results From R&D Validation Study of DetermaVu™ at the American Thoracic Society 2019 International Conference

Benzinga Newsdesk 5/21/2019 2:17:02 PM

OncoCyte Corporation (NYSE:OCX), a developer of novel, non-invasive tests for the early detection of cancer, today presented results from the Company's R&D Validation study at the American Thoracic Society (ATS) 2019 International Conference, which is being held May 17 to May 22 in Dallas. The poster details the compelling results from the Company's successful R&D Validation study of DetermaVu™, OncoCyte's liquid biopsy test for the early detection of lung cancer.

The R&D Validation study demonstrated a sensitivity of 90% (95% confidence interval from 82%-95%) and specificity of 75% (95% confidence interval from 68%-81%) of DetermaVu™ on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators.

'We are very pleased to present for the first time the strong findings from our R&D Validation study of DetermaVu™ at this year's ATS meeting. We believe these results are poised to redefine the paradigm in lung cancer detection,' said Lyndal Hesterberg, Chief Scientific Officer of OncoCyte. 'Most notably, we were able to achieve these results using gene-expression biomarkers alone and without the use of clinical parameters such as nodule size that are solely employed by the Mayo model and other algorithm models currently used to estimate the probability of cancer in patients with pulmonary nodules. Our unique Immune System Interrogation approach can potentially detect lung cancer in earlier stages of the disease when more favorable patient outcomes are feasible. We are excited about the potential of this novel test to positively impact the lives of patients globally, and are rapidly advancing through remaining development studies as we work to make DetermaVu™ commercially available in the second half of this year.'

Summary results:

A multivariate gene expression classifier was used to identify benign from malignant nodules between 5-30mm with a high degree of accuracy in a diverse population of current and former smokers

Using only gene-expression biomarkers from whole blood, and with no clinical parameters, the DetermaVu™ test yielded an overall Area Under the Curve (AUC) of 0.89 with Sensitivity ~90% (95% confidence interval of 82%-95%) and Specificity ~75% (95% confidence interval of 68%-81%)

This classifier significantly outperformed the Mayo algorithm model for cancer risk that utilizes only clinical factors such as nodule size
Poster details:

RAPiD: Rapid Abstract Poster Discussion Session

Day and time: Tuesday, May 21, 2019 - 2:15 - 4:15 PM CDT
Location: Arena (Level 2), KBHCCD
Poster Title: Blinded Prospective Validation Study of a Whole Blood Gene-Expression Classifier
for the Diagnosis of Benign Versus Malignant Pulmonary Nodules
Poster #: 421
Viewing Time: 2:15-2:45 PM CDT
Discussion Time: 2:45-4:15 PM CDT