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.

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

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

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

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 ...

The test received PDMA approval for colorectal cancer in June, making it the country's first PMDA-approved MRD test.

The firm also offered updates on its autoimmune disease, newborn screening, and other specialty diagnostics businesses from the sidelines of the conference.

The firm raised its full-year 2026 revenue guidance to a new range of $6.42 billion to $6.48 billion from prior guidance of $6.41 billion to $6.46 billion.

The issue of developing pediatric reference intervals for common laboratory tests has been one of the organization's priorities.

Executives disclosed new directions in neurodegenerative disease testing and low-volume sample collection for high-volume testing.