The DOJ alleged Agendia submitted false claims to Medicare, Medicaid, and other government payors for its MammaPrint breast cancer test.

The firm presented data at AACR that showed the test had high accuracy when distinguishing ovarian cancer at early stages.

The French firm said that its CaloPix slide image viewing and management software is cleared for use with a pair of scanners from Hamamatsu and Leica.

Investors and consultants in the space said that they have seen rising enthusiasm among investors as recent funding rounds ...

Among other impacts, the committee's closure could hamper efforts to modernize CLIA regulations, which has been a priority among many in the clinical lab space.

NEW YORK – A team led by investigators at Institut Pasteur has commenced work on a new lateral flow assay that could be used to detect the presence of the malaria-causing parasite Plasmodium vivax in ...

Tempus' FDA-approved xT CDx test is being used as an investigational assay in Verastem's global Phase 3 RAMP-301 clinical trial.

The lateral flow, fingerprick blood test measures monoclonal proteins, with results that can be read on a phone app.