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

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

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.

The Helsinki-based company said it will use the funds to support further development of its AI-based digital pathology platform.

Genprex plans to potentially integrate TROP2 expression for patient selection in NSCLC clinical studies, while Roche will validate assays using its TROP2 antibody.

The ELISA-based CIZ1B Biomarker Blood Test for Lung Cancer is designed to detect the lung cancer-produced biomarker CIZ1B. It was developed by UK-based Cizzle Biotechnology, which licensed it in the ...

The Chicago-based company is developing a POC field-effect transistor (FET)-based analyzer that it plans initially to target to the fertility testing space.