Rapid Novor’s Blood Test for Multiple Myeloma Monitoring is CLIA Certified for Clinical Use in the US
Rapid Novor Inc., the world’s leader in mass spectrometry (MS)-based antibody protein sequencing, announced today that its diagnostic laboratory obtained the Clinical Laboratory Improvement Amendments (CLIA) certification for their EasyM™ assay as a Laboratory Developed Test (LDT). EasyM™ is the world’s first personalized blood test for Multiple Myeloma to receive such certification. This means clinicians now have access to a simple blood test for highly sensitive measurable residual disease (MRD) monitoring of multiple myeloma.
Multiple myeloma is the second most common form of hematological (blood) cancer with ~175,000 new cases worldwide each year. 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,” said Dr. Liqiang Yang, 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 US 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.