Fujirebio's lung cancer blood test cleared in US
This article was originally published in Clinica
The US FDA has granted 510(k) clearance for Fujirebio Diagnostics' CYFRA 21-1 assay, which can now be used to monitor lung cancer progression and treatment. The Tokyo, Japan firm says the test is the first biomarker assay kit to be cleared by the FDA for use in the management of patients with lung cancer. CYFRA 21-1 can be used for the quantitative determination of soluble fragments of the tumour biomarker cytokeratin 19 in human serum. The test should be used in conjunction with other clinical methods of monitoring lung cancer.
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