NEW YORK – Proteotype Diagnostics is barreling toward the clinical market with a new study planned for Enlighten, its multicancer early detection test, while another study is set to commence that will ...

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.

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.