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.

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.