News and reporting on cell-free DNA testing.
The firm expects to receive a CE mark later this year for its RT-qPCR breast cancer recurrence assay, which characterizes epithelial CTCs by detecting cytokeratin-19 expression.
Natera alleges Inivata infringes its US Patent Nos. 10,262,755 and 10,597,709, which cover cancer monitoring and molecular residual disease testing.
The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
Last year, the company processed more than 1 million tests, most of them for its reproductive health business, but interest in Prospera and Signatera is growing.
The company had been working to expand its retrospective data over the last year and half and is now readying to move forward with prospective studies.
