TEST:

PDACatch assay

"Singlera Genomics...presented the results of its initial preclinical study of the PDACatch test, an assay to detect pancreatic cancer in individuals at high risk for the disease, at the HM Hospitals annual Hyper-early Diagnosis in Oncology and its Clinical Management meeting....As part of the preclinical study, Singlera demonstrated that the PDACatch assay could non-invasively retrospectively identify early stage pancreatic cancer in a background population of high-risk patients at high sensitivity."

Taken together, MGISEQ-2000 demonstrated similar data quality, consistency of the methylation levels, comparable analytic sensitivity, and matching clinical performance, supporting its application in future non-invasive early cancer detection investigations by detecting distinct methylation patterns of cfDNAs.

"Singlera Genomics...announced that it had received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its PDACatch assay, a novel DNA methylation-based liquid biopsy assay for the detection of pancreatic adenocarcinoma in individuals at high risk for the disease...Singlera Genomics is in the process of launching a prospective study and clinical trial to further evaluate and obtain pre-market approval for the PDACatch assay."