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OncoCyte Presents Positive Results from R&D Validation Study of DetermaVu™ at the American Thoracic Society 2019 International Conference

1099 Days ago

Results were achieved using blood gene expression biomarkers alone and without the use of clinical parameters

Company remains on-track to make DetermaVu™ commercially available in 2H 2019

ALAMEDA, Calif., May 21, 2019 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE American: 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

The poster can be viewed here.

About ATS

The American Thoracic Society improves global health by advancing research, patient care, and public health in pulmonary disease, critical illness, and sleep disorders. Founded in 1905 to combat tuberculosis (TB), the ATS has grown to tackle asthma, COPD, lung cancer, sepsis, acute respiratory distress, and sleep apnea, among other diseases.

About DetermaVu™

DetermaVu™ is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.

DetermaVu™ has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu™ can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.

DetermaVu™ is a trademark of OncoCyte Corporation

About OncoCyte Corporation

OncoCyte is focused on the development and commercialization of novel, non-invasive blood (“liquid biopsy”) diagnostic tests for the early detection of cancer. Early detection of cancer can improve health outcomes, reduce the cost of care, and improve patients’ quality of life. Liquid biopsy diagnostic tests like those OncoCyte is developing may reduce the need for costlier and riskier diagnostic procedures such as invasive biopsy procedures. OncoCyte is focusing its efforts on developing DetermaVu™ as a non-invasive confirmatory diagnostic test for lung cancer. DetermaVu™ is being developed using proprietary sets of genetic and protein molecular markers to detect the presence of lung cancer. OncoCyte also plans to conduct research to identify additional molecular markers, acquire or license markers and related technology, and develop cancer tests based on those markers.

OncoCyte 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) are forward-looking statements. These statements include those pertaining to the implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future 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 capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, the need and ability to obtain future capital, and maintenance of intellectual property rights, and the need to obtain 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 accordingly as such statements 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.

Investor Contacts

Bob Yedid
LifeSci Advisors, LLC

Media Contact

Andrew Mielach
LifeSci Public Relations

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