The clearances include one for an AI-assisted quality control software that detects six common whole-slide image artifacts.

Recent catalysts such as an FDA approval, NCCN guideline inclusion, and Japanese regulatory approval have fueled the firm's goals to expand its presence.

The clearance also includes a predetermined change control plan to lower regulatory hurdles around changes to the software's use.

The technology supports the adoption of digital pathology and artificial intelligence in cancer diagnostics by enabling greater consistency in laboratory slide staining.

Natera's Q2 net loss was $67.0 million, or $.47 per share, compared to a net loss of $100.9 million, or $.74 per share, in Q2 of last year. On average, analysts had expected a loss of $.53 per share.

The company also submitted a request for a CLIA waiver for the test, which would permit its use in decentralized testing locations.

Cancer early detection firm Grail said after the close of the market Wednesday that its second-quarter revenue grew 26 percent year over year, noting that it is preparing for an expected advisory ...