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FDA clears Fujirebio Diagnostics CYFRA 21-1 assay kit

The US Food and Drug Administration (FDA) has granted 510 (k) clearance to the Japan-based Fujirebio Diagnostics’ CYFRA 21-1 EIA assay to monitor disease progression during the course of disease and treatment of lung cancer patients.

The CYFRA 21-1 assay kit is indicated for the quantitative determination of soluble cytokeratin 19 fragments in human serum.

Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.

Data submitted to FDA showed that changes in CYFRA 21-1 values correlated with changes in disease status in 76% of the studied patient population.

Fujirebio Diagnostics Sales and Marketing VP Monte Wiltse said the clearance of the CYFRA 21-1 assay kit adds to Fujirebio’s growing portfolio of tumor marker assays for ovarian cancer, pancreatic cancer, breast cancer and other malignancies.