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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.
Funded by a five-year, $3.7 million NIH grant, the firm plans to offer an assay that is cheaper and less invasive than standard upper endoscopies.
The PAVmed subsidiary will have the option to license the biomarkers for a year after the completion of a Phase II study evaluating their accuracy.
The test detects methylation status at 31 sites and is used to determine elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease.
As part of the collaboration, UNC will use the firm's BarreGen assay to target molecular changes to predict resistance or relapse following ablation.
The company missed the analysts' average estimates on the top and bottom lines, but it raised its full-year 2019 revenue guidance.
The diagnostic can now be used to identify patients with esophageal squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
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.
The firm's tool uses a balloon catheter to collect cells from a targeted region of the esophagus without the need for endoscopy