News and analysis on disease research and diagnostics.
The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.
The assay could provide detection of HBV infection at early stages, potentially preventing progression to cirrhosis or hepatocellular carcinoma.
The company said that recent regulatory and reimbursement decisions have been favorable and will help spur adoption of clinical NGS testing.
The firm has developed microbubbles that bind to target molecules based on surface antibodies.
Named shieldin, the complex is involved in DNA damage repair processes and also plays a role in sensitizing BRCA1-depleted tumor cells to PARP inhibitors.
