EasyM, blood test for residual myeloma activity, certified in US
Easier and quicker way of monitoring people for cancer's return
Multiple myeloma patients in the U.S. will now have access to Rapid Novor‘s noninvasive and highly sensitive blood test for monitoring minimal residual disease activity, or the small number of cancer cells that remain in a patient’s body after treatment.
The test, called EasyM, previously was available only for research purposes. Its potential for clinical use follows the company’s diagnostic laboratory in Ontario, Canada, being given Clinical Laboratory and Improvement Amendments (CLIA) certification from U.S. regulatory authorities.
CLIA certification essentially means that the laboratory conducting these tests meets certain federal standards for laboratory testing on human samples in terms of accuracy, reliability, and timeliness.
“The CLIA certification for EasyM is a major milestone in multiple myeloma MRD testing,” Liqiang Yang, PhD, chief strategy officer at Rapid Novor, said in a company press release.
EasyM measures M-protein levels in a blood sample with high sensitivity
“EasyM now provides a much-needed option for patients with multiple myeloma who can benefit from frequent monitoring of their disease,” Yang added.
According to Rapid Novor, EasyM is the “world’s first personalized blood test for Multiple Myeloma to receive such certification,” and the company is seeking similar certification in Canada.
Minimal residual disease (MRD) activity is considered an important indicator of myeloma prognosis, since remaining cancer cells can drive disease relapse and progression. Even patients in complete remission who show no remaining signs of cancer require ongoing monitoring for MRD.
To date, the most sensitive way of measuring MRD involves obtaining bone marrow samples, an invasive, expensive, and time-consuming approach, Rapid Novor stated.
EasyM uses a small blood sample to measure the levels of M-protein, an abnormal antibody produced by myeloma cells that’s an established biomarker for the disease.
Other blood tests can measure M-protein to help with a myeloma diagnosis, but they aren’t necessarily sensitive enough to detect that small amounts that would be present with MRD, the company noted.
EasyM uses Rapid Novor’s proprietary sequencing technology to analyze a person’s M-protein sequence. That individual “fingerprint” is then used to quantify the protein over time, as often as needed.
In a recent pilot study involving 19 myeloma patients, EasyM accurately predicted MRD negativity, as assessed with a bone marrow-based test called clonoSEQ assay. It also showed greater sensitivity, detecting M-protein in 79% of samples considered MRD-negative by the clonoSEQ test.
That assay, which has U.S. Food and Drug Administration (FDA) clearance for use in myeloma patients’ bone marrow samples, uses DNA sequencing to look for signatures of cancer cells.
EasyM also might be able to predict a myeloma relapse up to 10 months earlier than traditional tests, according to Rapid Novor. In doing so, the test can support earlier and more informed decisions about treatment approaches.
It also could help in evaluating the potential of new myeloma therapies.
“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,” Yang said.
CLIA clearance marks EasyM as a laboratory developed test that can be manufactured and conducted only at Rapid Novor’s diagnostic lab in Ontario. Clinicians wishing to use the test for their patients will collect blood samples and ship them to that facility.