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Bio-Rad Gets FDA Clearance, CE Marking for Updated Tumor Marker Control

NEW YORK (360Dx) – Bio-Rad Laboratories today announced 510(k) clearance and CE marking for an updated version of the Liquichek Tumor Marker Control.

The updated control has four new analytes and is being launched for the immunoassay-based tumor marker testing market. The control now features HE4 and HER-2neu. The two other new analytes, proGRP and SCC, are available only outside of the US.

The control also offers low levels of prostate-specific antigen, high levels of cancer antigens, and ferritin.

Citing an industry report, Bio-Rad said that the immunoassay-based tumor marker testing market is estimated to reach $1.4 billion by 2021.