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Somalogic Launches Validation Studies of Protein Biomarkers for Pancreatic Cancer and Mesothelioma

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By Adam Bonislawski

Clinical proteomics firm Somalogic has begun validation of its protein biomarker-based diagnostics for pancreatic cancer and mesothelioma.

For each test – both of which employ roughly a dozen proteins detected using the company's Somamer detection platform – Somalogic is planning trials on the order of 400 patients, which it expects to finish within a year, clinical research director Rachel Ostroff told ProteoMonitor.

The pancreatic cancer panel – to which Quest Diagnostics has the commercial rights – is aimed at two clinical indications. The first, Ostroff said, is as a screening test in high-risk populations, such as "people with a family history or known genetic predisposition or people who have high levels of smoking and alcohol use."

The second use is as a differential diagnostic to help physicians determine whether a patient showing symptoms consistent with pancreatic cancer does, in fact, have the disease.

The panel will be adapted for each indication by varying the decision thresholds according to the intended use, Ostroff said. In the case of the screening test, specificity will be maximized to avoid false positives that could lead to unnecessary biopsies. In the case of the differential diagnostic, sensitivity will be maximized given that patients presenting symptoms would likely be moved on for additional procedures regardless.

Ostroff said that given the rarity of pancreatic cancer in even high-risk populations, the screening test would need a specificity of approximately 98 percent to be useful. In data presented at last month's American Association for Cancer Research International Conference on Molecular Diagnostics in Cancer Therapeutic Development, the pancreatic cancer panel showed specificity of 97 percent and sensitivity of 66 percent. Adjusted for differential diagnoses purposes, it demonstrated sensitivity of 92 percent and specificity of 60 percent.

The company also presented data showing that its mesothelioma panel demonstrated 100 percent specificity with 80 percent sensitivity. Somalogic is currently exploring commercialization strategies including possible partnerships for this diagnostic, director of corporate strategy Mark Messenbaugh told ProteoMonitor.

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