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Bioprognos Gets CE Mark for Lung Cancer Dx Algorithm

NEW YORK (360Dx) – Spanish diagnostics firm Bioprognos announced yesterday that it has received CE marking for MBDAA for Lung Neoplasia Dx — an algorithm used in the diagnosis of lung cancer — clearing it for sale in the European Union.

MBDAA is short for multiple biomarkers disease activity algorithm. According to Bioprognos, the lung cancer algorithm calculates a patient's risk for developing the disease, and provides a histological determination in the case of a positive result. It works by combining the values of six tumor markers obtained through a blood test along with other patient data. It has a sensitivity of 90 percent and a specificity of 98 percent.

The algorithm was developed based on the results of a eight-year study conducted at the Hospital Clínic de Barcelona using technology from the hospital and the Fundació Clínic per a la Recerca Biomèdica, Bioprognos said.

The company also has MBDAA algorithms for ovarian and prostate cancers in the final stages of validation, and it intends to pursue regulatory approval for its diagnostic algorithms in the EU, the US, and China.