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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
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
- 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
|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
|Viewing Time:||2:15-2:45 PM CDT|
|Discussion Time:||2:45-4:15 PM CDT|
The poster can be viewed here.
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.
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
DetermaVu™ is a trademark of
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