New York University researchers presented data at last week's American Association for Cancer Research annual meeting in Orlando, Fla., on a study using Somalogic's Somamer technology for the detection of protein biomarkers for malignant mesothelioma.
In the study, a panel of 13 protein biomarkers distinguished between blood samples from 38 mesothelioma patients and 62 asbestos-exposed controls with a sensitivity and specificity of 92 percent, said Harvey Pass, director of the division of thoracic surgery and thoracic oncology at NYU Langone Medical Center and leader of the study.
The 13 proteins were identified using Somalogic's Somamer detection platform – an array of more than 1,000 specialized aptamers – to screen 170 blood samples from 90 patients diagnosed with malignant mesothelioma and 80 participants with previous asbestos exposure. The work follows a smaller 39-subject study that Pass and Somalogic presented in October in which the panel distinguished mesothelioma cases from controls with 100 percent specificity and 80 percent sensitivity (PM 10/15/2010).
In the case of mesothelioma diagnostics, "you're shooting for the highest sensitivity possible," Pass told ProteoMonitor. Such a test, he said, would be used to screen high-risk individuals such as those previously exposed to asbestos. Positive cases would be sent for imaging via CT scan or endoscopy.
Mesothelioma is estimated to cause 15,000 to 20,000 deaths per year. Treatment is most effective when started in stage 1 of the disease, but currently there are no good early diagnostics, Pass noted.
Soluble mesothelin-related protein has been considered a potential biomarker for the disease, but, Pass said, "we've been looking at [it] for the last five years, but it doesn't have nearly the characteristics of this [13-protein panel]. For SMRP the area under the curve is approximately .78 to .8 – done many times in many different populations – as opposed to this test, where we're getting areas under the curve that approach .96, .97."
Much of the work on SMRP was done on subjects from the Carotene and Retinol Efficacy Trial – an 18,314-subject trial studying the effects of beta-carotene and retinyl palmitate on patients at high risk of lung cancer. The population included a 9,000-individual asbestos-exposed cohort that Pass noted he and Somalogic have access to through their participation in the Early Detection Research Network.
"Blood [from these 9,000 subjects] was measured on a yearly basis over ten years, and 49 mesotheliomas developed from that cohort," he said. "It's a perfect uniform cohort for the next step of validation for this sort of [test] and I think the [US Food & Drug Administration] will look very favorably if the performance in that cohort is comparable to what we've seen."
Pass has also received a three-year grant through the EDRN to screen the populations of several villages in central Turkey that have exhibited extremely high rates of mesothelioma.
"That will start later on this year," he said, "and we will be taking specimens over the three-year effort that will be extra that we could longitudinally profile if [Somalogic] wishes."
According to Somalogic director of corporate strategy Mark Messenbaugh, the company is currently exploring commercialization strategies including possible partnerships for the diagnostic, but "nothing has been set on that."
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