Recently, Adaptive Biotechnologies Corporation received expanded FDA clearance for their clonoSEQ Assay. Using this specific assay, they are able to assess “Minimal Residual Disease” or MRD in Patients with Chronic Lymphocytic Leukemia. Adaptive Biotechnologies is a commercial biotechnology company that focuses on bridging the gap between genetics of the immune systems to clinical products that diagnose and treat disease. With the FDA approval, clonoSEQ is the first and only FDA-cleared in vitro diagnostic for MRD monitoring for Chronic Lymphocytic Leukemia. ClonoSEQ can detect one single cancer cell among millions of healthy cells.
Source: https://investors.adaptivebiotech.com/news-releases/news-release-details/adaptive-biotechnologies-receives-expanded-fda-clearance