Thermo Fisher Scientific Reports the US FDA’s Extended Approval of Freelite Assays for Multiple Myeloma
Shots:
- The US FDA has granted extended 510k clearance to Optilite Freelite assays for the assessment of monoclonal gammopathy of undetermined significance (MGUS), antecedent to multiple myeloma
- Freelite assays are used to diagnose & monitor monoclonal gammopathies by measuring serum kappa and lambda free light chains and detecting small amount of monoclonal FLC proteins that are not identified by serum protein electrophoresis
- The assay has been FDA cleared to diagnose & monitor multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinemia, AL amyloidosis, light chain deposition disease, and connective tissue diseases like systemic lupus erythematosus (SLE)
Ref: Bayer | Image: Bayer
Related News:- Bayer and Thermo Fisher Scientific Partner to Develop NGS-Based Companion Diagnostic Assays (CDx)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
