Rapid Novor, a provider in mass spectrometry (MS)-based antibody protein sequencing, announced its diagnostic laboratory obtained the Clinical Laboratory Improvement Amendments (CLIA) certification for their EasyM assay as a laboratory developed test (LDT).
With the EasyM personalized blood test for Multiple Myeloma, clinicians have access to a simple liquid biopsy for highly sensitive measurable residual disease (MRD) monitoring of multiple myeloma, the company says.
Multiple myeloma is the second most common form of hematological cancer with roughly 175,000 new cases worldwide each year, according to the company. The presence of MRD is an important prognostic factor for multiple myeloma and typically requires ongoing assessments for detection and monitoring of disease progression. However, current clinical tests for MRD often lack the sensitivity or require the invasive, expensive, and time-intensive practice of bone marrow biopsies—putting physical and financial burden on the patients.
“The CLIA certification for EasyM is a major milestone in multiple myeloma MRD testing,” says Liqiang Yang, PhD, chief strategy officer at Rapid Novor. “EasyM now provides a much-needed option for patients with multiple myeloma who can benefit from frequent monitoring of their disease especially during the complete remission (CR) stage without invasive bone-marrow aspirates. The non-invasive and highly sensitive nature of EasyM makes it an ideal assay to assess MRD status as an efficacy endpoint for clinical trials of novel therapeutic drugs.”
The EasyM assay measures the levels of M-protein—a well-known biomarker for multiple myeloma—using Rapid Novor’s proprietary MS-based protein sequencing technology. EasyM can improve the way the disease is monitored to foster informed decisions on potential therapies and treatment regimens. Data from retrospective clinical studies suggest that EasyM could provide earlier predictions of relapse compared to conventional methods.
The CLIA certification of Rapid Novor’s Diagnostic Laboratory means that patients in the U.S. diagnosed with multiple myeloma will now be able to access EasyM as a clinical testing option for enhanced disease monitoring. Rapid Novor is currently in the process of obtaining certification of the EasyM assay within Canada to bring this non-invasive, sensitive, clinical test to Canadian patients with multiple myeloma.