epigenetics

The company recently had a second pre-submission with FDA and expects to begin a prospective trial of its test in the second half of this year.

The Oslo-based company plans to develop a test that can identify high-risk individuals based on an epigenetic signature.

The company recently presented results from its Aurora assay for multi-cancer screening and plans to launch a $100 test for the US and Chinese markets.

The firm is planning a hybrid approach to clinical translation, including launching some of its own cancer tests and licensing technology to other labs.

The firm expects to launch a 510(k)-cleared version of its Bladder EpiCheck recurrence assay early next year followed by an RUO early-stage lung cancer assay.

The company's goal is to serve what it sees as a massive but underaddressed target group: Asian women.

The company reported that its genome-wide methylation approach could detect 77 percent of stage II cancers in its ongoing case-control CCGA study.