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

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

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

Upfront will use the proceeds to accelerate the commercialization of its lateral flow test, called LVOne, for triaging stroke ...

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.

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 ...

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.

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.

NEW YORK – Roche announced on Wednesday that its Ventana MET (SP44) RxDx Assay has received approval from the US Food and Drug Administration for use as a companion diagnostic to determine which lung ...

NEW YORK – OncoHost said Thursday that it and three partner medical centers will use a €2.5 million ($2.80 million) grant from the EU's European Innovation Council Transition program to develop a ...