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.