The ClonoSIGHT MRD test has been shown to offer sensitivity for the detection of residual cancer cells in marrow or blood. Test results are generated in 7 days using the company’s CLIA-certified laboratory and can be used to better measure a patient’s risk of post-treatment relapse and guide subsequent care.
“The launch of ClonoSIGHT marks an important step toward improved treatment paradigms in blood cancers, which are driven by sensitive and specific measurements of residual disease,” says Tom Willis, PhD, Sequenta’s CEO. “This product builds on more than 2 decades of clinical research into the value of MRD and brings the incredible power of next-generation sequencing to bear on the important problem of rare cancer cell detection.”
The test uses the company’s proprietary LymphoSIGHT™ platform, which works by sequencing unique DNA signatures that are present in immune cells to allow tracking of malignant subpopulations even when they are present at levels as low as one cell per million white blood cells. The sequencing-based readout provides quantitative results that can be directly interpreted by oncologists.
“The LymphoSIGHT technology has been validated in the past year in more than 10 clinical trials, two of which have already appeared in peer-reviewed journals, with others under review,” says Malek Faham, MD, PhD, chief scientific officer, Sequenta. “These studies have demonstrated not only the technical improvements in sensitivity and specificity of the ClonoSIGHT test, but also the relevance of its performance for patient prognosis in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL).”
These early studies have shown that the LymphoSIGHT method was able to detect residual disease in as many as 10% of children with ALL who were negative by flow cytometry. It also detected residual disease in significant numbers of MCL patients who were negative by PET scans and subsequently suffered fatal relapses, the company says. Larger studies, including prospective studies conducted by oncology cooperative groups, are currently under way to extend the validation of the test.