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.