Preliminary Validation of Panel of 9 Protein Biomarkers That Detected
Lung Cancer with 92% Sensitivity and 93% Specificity in Independent
Cohort
Celera Corporation (NASDAQ:CRA) today announced the presentation of data
replicating its novel mass spectrometry-based approach to identify and
validate circulating protein biomarkers that detect non-small cell lung
cancer (NSCLC) in an independent cohort of individuals with lung cancer.
This study was performed in collaboration with scientists at NYU Langone
Medical Center, NY. A key outcome of the study was the validation of a 9
biomarker immunoassay on a cohort of samples that is enriched for stage
I disease, important for screening of early stage disease. The assay
detected lung cancer with 92% sensitivity at 93% specificity. The panel
also accurately distinguished malignant cases from benign lung disease.
The data is being presented at the 13th World Conference on
Lung Cancer as part of the International Association for the Study of
Lung Cancer (IASLC) in San Francisco, CA.
This study confirms the performance of a 9 member biomarker panel
previously presented at the 100th Annual American Association
for Cancer Research (AACR) Conference in April 2009. In addition, the
authors report the high performance of a 6 marker panel derived from the
9 marker panel which distinguishes malignant cases with 92% sensitivity
at 88% specificity. Celera expects to continue the evaluation of the
clinical utility of both the 6 and 9 marker panels in an effort to
determine which panel would offer optimal performance in a broad
clinical setting.
“This is one of the most promising assays I’ve seen as a predictor of
non-small cell lung cancer,” said Harvey I. Pass, M.D., Professor of
Cardiothoracic Surgery and Director of Thoracic Surgery and Oncology at
the New York University Langone Medical Center and its NYU Cancer
Institute. “Such a test with this accuracy, if validated prospectively
in other larger cohorts, may impact the management of individuals with
presumed or diagnosed non-small cell lung cancer in the future.”
“The Early Disease Research Network initiative of National Cancer
Institute is committed to identifying a biomarker test for early
detection of lung cancer that demonstrates robust performance,” said
William N. Rom M.D., M.P.H., the Sol and Judith Bergstein Professor of
Medicine and Environmental Medicine at the New York University Langone
Medical Center. ”The work from this collaboration has resulted in a very
promising set of biomarkers that warrant continued study. Such a test
could potentially provide clinically useful information for physicians
and their patients.”
“We’re pleased to see the performance confirmed in an independent cohort
since we believe this assay presents a robust test to detect lung cancer
using a simple blood test,” said Steve Ruben, Ph.D., Vice President of
Proteomics at Celera. “We believe the ability to identify a collection
of biomarkers, which we have subsequently shown to be elevated in the
blood of non-small cell lung cancer patients relative to appropriate
controls, presents an opportunity to detect the disease earlier,
enabling more effective intervention and monitoring. This test in
combination with helical CT imaging may increase the predictive value of
these tests over CT alone.
