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.
Executives disclosed new directions in neurodegenerative disease testing and low-volume sample collection for high-volume testing.
The firm also offered updates on its autoimmune disease, newborn screening, and other specialty diagnostics businesses from the sidelines of the conference.
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 issue of developing pediatric reference intervals for common laboratory tests has been one of the organization's priorities.
The company also submitted a request for a CLIA waiver for the test, which would permit its use in decentralized testing locations.
Genprex plans to potentially integrate TROP2 expression for patient selection in NSCLC clinical studies, while Roche will validate assays using its TROP2 antibody.
The test received PDMA approval for colorectal cancer in June, making it the country's first PMDA-approved MRD test.
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