In Multiple Myeloma (MM), antibody-producing plasma cells undergo malignant clonal expansion, resulting in the production of unique aberrant antibodies known as Myeloma (M) proteins. The malignant plasma cells (and their DNA and RNA) remain in the bone marrow, with only a very small amount circulating in the blood. The sensitivity of DNA sequencing-based tests is hence greatly limited to the location of the tumour in the bone marrow and the amount of biopsy tissue available.
In contrast, the secreted M-protein circulates in the blood. This feature of MM makes the M-protein an attractive biomarker, whose unique sequence is accessible only through protein sequencing and is thus not confounded by antibody therapeutics used in treatment, unlike SPEP and IFE. Since the blood of most MM patients contains highly abundant M-proteins unique to each patient, our technology can exploit the nature of MM for a more sensitive, frequent, and personalized test. To monitor patient-specific M-protein levels, EasyM™ involves two steps:
First Step : Decoding the M-protein
A patient’s M-Protein is first sequenced directly from a diagnostic blood sample to identify patient-specific, unique protein sequences.
Second Step : Monitoring the M-protein
Identified unique protein sequences are tracked using EasyM™’s built-in, targeted, and personalized assay to quantify and monitor the M-protein in patients during and post-treatment.
EasyM™ exploits both mass spectrometry (MS)-based protein sequencing and quantification technologies enhanced by machine learning algorithms. The company’s core protein sequencing technology is rooted in Rapid Novor’s team experience of over 20 years of academic and industry research and innovations. This technology allows high-throughput reading of the full sequence of unknown proteins. Protein sequencing is a novel technology with unique advantages over conventional (DNA) sequencing in disease detection. Furthermore, EasyM™’s technology does not require the use of bone marrow aspiration and is more sensitive than other conventional blood biopsies.
EasyM™ has been validated in a retrospective clinical trial with 55 patients, and over 300 historical blood samples in collaboration with a large Canadian hospital. In this retrospective study, EasyM™ was capable of detecting relapse as early as 8 months before SPEP and IFE standard methods. Results from this study have been published at the 2018 and 2019 annual meetings for the American Society of Hematology. Another large clinical trial is ongoing in collaboration with a major center in the US.
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Earlier Relapse Detection.
Truly personalized monitoring for Multiple Myeloma patients