Compelo Medical Devices is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

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.