The US Food and Drug Administration (FDA) granted 510(k) clearance to the EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay, a first-of-its-kind automated platform for detecting and isotyping M-proteins in patients with multiple myeloma and related disorders.
The EXENT system offers increased sensitivity for low-concentration M-proteins by molecular weight, reducing subjective interpretation and flagging exogenous ones from therapeutic antibodies. It supports evaluation of multiple myeloma, smoldering multiple myeloma, Waldenström’s macroglobulinemia, amyloid light chain amyloidosis, and monoclonal gammopathy of undetermined significance. The platform provides up to six hours of walkaway time per shift and requires no mass spectrometry, according to the press release from Thermo Fisher Scientific, the manufacturer.
The EXENT system is now available in the US and more than a dozen countries worldwide, including Canada, Australia, and most of Europe.
“Our continued goal is to equip laboratories and clinicians with technologies that deliver greater accuracy, efficiency and clarity, enabling more informed clinical decisions and improving the patient journey,” said Stephen Harding, vice president and general manager, protein diagnostics, at Thermo Fisher Scientific.
