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Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis

Shots: Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT Analyser & Immunoglobulin Isotypes (GAM) Assay, an automated mass spectrometry-based platform, for aiding diagnosis of MM & related conditions The EXENT System detects & isotypes low-concentration M-proteins with high sensitivity to identify them by molecular weight, differentiating endogenous from therapeutic antibodies & providing…

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