Thermo Fisher Scientific has received U.S. Food and Drug Administration (FDA) clearance for its EXENT System, an automated test that helps doctors diagnose multiple myeloma.
The system detects and identifies abnormal antibodies called M-proteins, which are produced by cancerous plasma cells and play a crucial role in the disease. By providing fast, sensitive, and reliable results, the EXENT System can help doctors detect multiple myeloma earlier, according to Thermo Fisher.
FDA clearance is required for medical devices to be used in the U.S. and essentially means that the system meets the FDA’s safety guidelines for such use. The system is now available for clinical use in the U.S. and Canada, where it was also recently cleared, as well as in Australia, New Zealand, Brazil, and several European countries.
“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, a researcher at University Hospital Salamanca, Spain, said in a Thermo Fisher press 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.”
Automated results speed diagnosis
Multiple myeloma is a form of blood cancer that originates in plasma cells, immune cells responsible for producing antibodies that help the body fight infection. In multiple myeloma, these plasma cells grow uncontrollably inside the bone marrow, the soft tissue where new blood cells are made. As they multiply, myeloma cells release abnormal antibodies known as M proteins.
The type of myeloma a person has is determined by the kind of M-protein produced. Antibodies are made up of two parts: a heavy chain (IgG, IgA, IgD, IgE, or IgM) and a light chain (kappa or lambda). The combination of these chains identifies the M-protein type.
A myeloma diagnosis can be a slow process. It relies on multiple medical tests, including blood and urine analysis to detect M-protein and other markers, as well as a bone marrow biopsy and imaging tests to detect abnormal plasma cell growth.
The EXENT system is designed to detect and classify M-proteins at low levels, providing automated and accurate results that reduce the need for manual interpretation, thereby helping clinicians diagnose the disease more quickly. The system combines Thermo Fisher’s EXENT Analyser with the company’s EXENT GAM Assay to quantify and track specific M-proteins.
EXENT GAM Assay separates M-proteins using paramagnetic beads, small particles that bind to human IgG, IgA, IgM, total kappa, and total lambda, and separate them using a magnetic field. The isolated antibodies are then identified based on their molecular mass through mass spectrometry and analyzed using data analysis software to quantify M proteins.
The system can also distinguish M-proteins associated with the disease from those derived from sources such as therapeutic antibodies, giving clinicians insights into disease status.
“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, PhD, Thermo Fisher’s vice president and general manager of protein diagnostics. “The EXENT System reflects Thermo Fisher’s commitment to advancing diagnostic solutions that meet well-defined clinical needs.”
According to the company, the system can also help diagnose and evaluate Waldenström’s Macroglobulinemia, a type of B-cell cancer characterized by high IgM levels. It can also help detect smoldering multiple myeloma, the asymptomatic precursor to active multiple myeloma; light-chain amyloidosis, when plasma cells produce high levels of abnormal light-chain proteins that clump into fibrils in organs; and monoclonal gammopathy of undetermined significance, a related, precancerous condition.
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