NEW YORK – In July, the US Food and Drug Administration granted more than a dozen 510(k) clearances to in vitro diagnostic products, including offerings from Hamamatsu, Roche, Cepheid, and Siemens ...

An analyst with investment bank Leerink partners noted that Freenome is addressing a significant total addressable market in liquid biopsy cancer screening.

LisenID uses a biomarker called loss of imprinting to apply to ambiguous biopsy results and return a diagnosis of lung cancer.

Natera's tissue-free assay Latitude will be used in Kupando's clinical trial of its lead immunotherapy candidate KUP-101.

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

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

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

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.

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