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AnchorDx Receives CE Mark for Lung Cancer Early Diagnosis Test

NEW YORK – Chinese oncology diagnostics firm AnchorDx said Wednesday that its PulmoSeek lung cancer early detection assay, has received CE marking, with a reagents license issued by the Netherlands' CIBG of Ministry of Health, Welfare, and Sport.

PulmoSeek uses cell-free DNA methylation analysis to identify epigenetic patterns specific to malignant cells and is intended for cancer detection and diagnosis in individuals with pulmonary nodules between 5 and 30 millimeters. According to the Guangzhou, China-based company, prospective clinical data has previously shown the test to have 100 percent sensitivity in a subgroup of 6-to-20-millimeter nodules and 97 percent sensitivity for stage I tumors, outperforming CT scans in a study published last year.

The CE mark will allow the firm to promote its lung cancer assay for the first time in countries that recognize the classification.

In the long term, AnchorDx has said it intends to develop its technology to support screening tests for the early detection of six major cancer types.