Fujirebio Diagnostics Inc has received FDA 510(k) clearance for its CYFRA 21-1™ EIA assay to monitor disease progression during the course of disease and treatment of lung cancer patients. This is the first biomarker assay kit to be cleared by the FDA for use in the management of patients with lung cancer.
"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," commented Monte Wiltse, VP of sales and marketing at Fujirebio Diagnostics. "Achieving FDA clearance of the CYFRA 21-1 assay kit for lung cancer is the first step in what we anticipate will be a strong pipeline of innovations that help physicians in the management of lung cancer."
The CYFRA 21-1 assay kit is indicated for the quantitative determination of soluble cytokeratin 19 fragments in human serum. It is to be used as an aid in monitoring disease progression during the course of disease and treatment in patients with lung cancer. 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.
According to the Surveillance Epidemiology and End Results (SEER) database of the National Cancer Institute (NCI), an estimated 222,520 new cases of lung cancer were diagnosed in the US in 2010, and roughly 157,300 Americans died of the disease.
Source: Fujirebio Diagnostics Inc