Sebia launches M-inSight®, a test for monitoring
multiple myeloma patients
Corgenix, a Sebia Group company, CAP/CLIA clinical laboratory,
positions Sebia to globally commercialize M-inSight®, a novel noninvasive liquid biopsy assay for Minimal Residual Disease (MRD)
monitoring in multiple myeloma
Paris, France, September 27, 2023 – Sebia, a world leader in multiple myeloma
diagnostics and monitoring, today announces the launch of its serum based Minimal
Residual Disease (MRD) test for monitoring in multiple myeloma. M-inSight® is aLaboratory Developed Test (LDT) being offered by Corgenix, College of American
Pathologists (CAP)-accredited, Clinical Laboratory Improvement Amendments (CLIA) licensed clinical laboratory and part of the Sebia Group.
M-inSight® is a personalized, targeted mass spectrometry assay, to detect with
unprecedented sensitivity the monoclonal protein (M-protein) secreted by the patient’s
tumor cells in serum. The technology is based on clonotypic peptides mass spectrometry,
which avoids the interference with the polyclonal background leading to an ultra-sensitivetest.
MRD describes the low levels of myeloma cells that persist in the bone marrow after
treatment but cannot be detected with conventional outcome measures and eventuallylead to relapse. MRD status is an important prognostic marker and studies have shown its
potential as a surrogate endpoint for progression-free survival. MRD testing monitors theeffectiveness of a treatment and could be a driver in treatment decisions.
As new therapies emerge to treat patients suffering from multiple myeloma, there is anurgent need for high sensitivity MRD testing in serum to track disease burden andtreatment efficacy, without the limitations of current bone marrow-based assays. Theseare typically invasive, painful and not suited for frequent measurement.
M-inSight® was developed in partnership with Erasmus Medical Center, Rotterdam andRadboud University Medical Center, Nijmegen, both in The Netherlands.
“We are proud to launch M-inSight® to improve the management of multiple myeloma andquality of life for patients, as well as assisting in the drug development and validation
process”, said Dr Pierre Sonigo, chief scientific officer at Sebia. “By testing in serum withequivalent sensitivity to bone marrow, we will solve current challenges in multiple myeloma
MRD-testing, allowing for a more frequent and reliable monitoring of response totreatment.”
Sebia is currently the only global partner covering the process of M-protein testing frominitial detection to MRD and is committed to developing other liquid biopsy tests such as
Circulating Tumor Cells (CTC) and new biomarkers.
About multiple myeloma
Multiple myeloma is the second most common blood cancer in the world, affecting morethan 170,000 people worldwide. Multiple myeloma is the cancer of plasma cellscharacterized by the clonal expansion of plasma cells that predominantly reside in the bonemarrow. Each year over 32,000 new cases are diagnosed in the United States, and almost

13,000 patients die of the disease. Patients with multiple myeloma continue to relapse
over time, making it a difficult to treat and incurable malignancy.
About M-inSight®
M-inSight® is a Laboratory Developed Test (LDT) validated for clinical use, offered byCorgenix, a Sebia Group company, a CAP-accredited CLIA-licensed clinical laboratory.
Patients suffering from multiple myeloma can now have access to M-inSight®. Pharmacompanies developing and commercializing drugs in multiple myeloma can also benefit
from this innovative assay to get deeper insights in their drug development and clinical
trials.
www.minsight-mrd.com
About Corgenix
Corgenix is a CAP/CLIA accredited laboratory based in Colorado, USA. Founded in 1990
and part of the Sebia group, it is specialized in clinical trial management and physicianordered patient testing.
The company also has CDMO capabilities catering to clients in the biotechnology andpharmaceutical industry, cancer centers and academic laboratories.
www.corgenix.com
About Sebia
Founded in 1967, Sebia is a world-leading provider of clinical protein electrophoresis
equipment and reagents, a technology used for in vitro diagnostic testing. Its systems
analyze proteins in order to screen and monitor various diseases and conditions; primarily
oncology (multiple myeloma), metabolic disorders, hemoglobinopathy, rare diseases andmore recently autoimmunity. Sebia is offering the largest range of analytical solutions indiagnosis and monitoring of multiple myeloma, including serum and urine protein(s)electrophoresis (SPE/UPE) for screening and identification (Immunotyping /Immunofixation), measurement of FLC and follow-up monoclonal antibody therapy with
HYDRASHIFT portfolio.
www.sebia.com
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