The cell collection device already has FDA clearance, while the firm intends to conduct trials in support of a filing for marketing clearance of the assay.
The test detects methylation status at 31 sites and is used to determine elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease.
The test relies on a signature that Almac developed for stratifying breast cancer patients, but which, as the researchers showed, can be used in other cancers as well.
The JHU technology leverages an epigenetic biomarker panel and a sponge-on-a-string collection device, as well as a PCR-based method, to detect Barrett's esophagus.
