The FDA granted 510(k) clearance to the EXENT System to aid in the diagnosis of multiple myeloma and related disorders.
The FDA has granted 510(k) clearance to the EXENT Analyser and Immunoglobulin Isotypes (GAM) Assay (EXENT System) to aid in the diagnosis of multiple myeloma and related disorders.1
With 510(k) clearance, the EXENT System is now permitted for clinical use in the United States, and it is also cleared for use in Canada, Australia, Belgium, Brazil, France, Germany, Italy, the Netherlands, New Zealand, Spain, Switzerland, and the United Kingdom.
“The clearance of the EXENT System represents a significant advancement in the tools available to aid in the diagnosis of multiple myeloma,” Noemi Puig, MD, PhD, of the Department of Hematology of University Hospital Salamanca in Spain, stated in a news release. “By combining increased sensitivity with ease of use and automated workflows, laboratories can achieve greater clarity and diagnostic confidence, ultimately supporting improved patient care.”
By identifying M-proteins based on unique molecular weight, the EXENT System is designed to allow for the clear detection of naturally occurring endogenous proteins and known exogenous M-proteins, such as those stemming from therapeutic antibodies. The EXENT System is intended to aid in the diagnosis of multiple myeloma, Waldenström macroglobulinemia, and amyloid light chain amyloidosis, and it can also assist in the evaluation of monoclonal gammopathy of undetermined significance (MGUS).
“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,” Stephen Harding, vice president and general manager of Protein Diagnostics at Thermo Fisher Scientific, added in the news release. “The EXENT System reflects Thermo Fisher’s commitment to advancing diagnostic solutions that meet well-defined clinical needs.”
The EXENT System is an automated mass spectrometry solution designed for monoclonal gammopathy diagnostics, enabling the identification and measurement of M-proteins in serum with increased sensitivity beyond conventional testing methods.2 The system includes 3 steps: sample preparation, analysis, and review.
The sample is automatically performed by the liquid handler before being analyzed, and during this process, the system automatically isolates immunoglobulins via isotype-specific paramagnetic reagents. During analysis, the MALDI-ToF mass spectrometer uses load and click technology to rapidly analyze the patient sample. By combining integrated calibration and control routines with automated sample measurement, the need for expertise in the use of mass spectrometry is removed. Results are then prepared for review using intuitive workflow and data management software. The EXENT System can manage a throughput of up to 150 samples today, along with up to 50 samples in individual runs.
Per the International Myeloma Foundation, more than 176,000 patients worldwide are diagnosed with multiple myeloma each year; however, current diagnostic pathways have been associated with slow and uncertain results, in part due to subjective interpretation.1,3
In a review of challenges and delays in diagnosis of multiple myeloma published in Diagnostics (Basel), study authors concluded that although multiple myeloma is the second most common hematologic malignancy worldwide, diagnosis is often delayed due to non-specific symptoms, lack of awareness, and multifactorial barriers with patients, clinicians, and health care systems.3 As such, diagnosis of multiple myeloma can often occur at later stages of the disease, leading to increased morbidity and worsened quality of life.
Study authors concluded that reduction in diagnosis delays can be aided in the future by increased awareness via educational programs, the development of algorithm-based approaches in primary care settings, the integration of artificial intelligence tools, and the use of biomarker-based risk assessment, particularly for patients with MGUS.
