The assay is designed to detect minimal residual disease with greater sensitivity than conventional flow cytometry.
ARUP Laboratories announced the launch of ARUP Clarispect Multiple Myeloma MRD by Spectral Flow Cytometry, an assay designed to characterize small neoplastic populations with higher sensitivity than conventional flow cytometry. The test provides minimal residual disease (MRD) profiling for patients with multiple myeloma, according to a press release from ARUP Laboratories.
ARUP Laboratories positions itself as the first large reference laboratory in the US to offer spectral flow technology for clinical use.
“We are harnessing a technology that’s relatively new in the diagnostic space,” says Madhu Menon, MD, PhD, head of clinical operations for hematopathology at ARUP, in a release. “By offering a superior technique with higher sensitivity, we will directly impact a subset of patients who otherwise would not have been identified as MRD positive.”
Multiple myeloma, a cancer of plasma cells that produce antibodies, affects approximately 202,000 individuals in the US, based on 2023 data. The American Cancer Society estimates that 36,000 new cases will be diagnosed in 2026.
MRD assessment is used for the evaluation of treatment efficacy, as well as prognostication and risk stratification. MRD status is associated with clinical outcomes because higher levels of residual disease indicate an increased likelihood of relapse.
“We will be able to detect the reemergence of disease at an earlier timepoint, which will then facilitate more informed decisions at an earlier timepoint,” says Menon in a release.
Spectral flow cytometry technology captures emission data across the full spectrum of light, making it possible to interrogate more than 40 markers simultaneously. The assay for multiple myeloma assesses 18 markers. By consolidating relevant markers into a single tube, the assay requires less specimen volume, which is vital for difficult-to-obtain specimens such as bone marrow.
“The number of antigens we can bring to bear will facilitate easier interpretation and, by extension, greatly increase our sensitivity,” says David Ng, MD, medical director of hematopathology, hematologic flow cytometry, and applied artificial intelligence and bioinformatics at ARUP, in a release.
The assay can identify extremely low levels of residual disease, detecting as few as 14 neoplastic cells in a population of 5 million analyzed cells with 95% confidence, according to Ng.
“We see large volumes with high complexity cases, including rare diseases,” says Tracy George, MD, ARUP chief scientific officer and president of the innovation business unit, in a release. “This ensures not only the breadth and depth of our validation, but also the quality of our interpretations.”
ARUP Laboratories plans to continue expanding its MRD by spectral flow cytometry testing suite.
Photo caption: ARUP Clarispect Multiple Myeloma MRD by Spectral Flow Cytometry characterizes small neoplastic populations with greater sensitivity than conventional flow cytometry while requiring less specimen volume.
Photo credit: ARUP Laboratories