On May 21, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported its 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 (Press release, BioTime, MAY 21, 2019, View Source;p=RssLanding&cat=news&id=2399321 [SID1234536544]). 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.
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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:
Session: 110 – THE FUTURE OF LUNG CANCER BIOMARKERS: WHERE SHOULD WE LOOK?
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