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.

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 ...

NEW YORK – Tribun Health said Tuesday that it has secured US Food and Drug Administration 510(k) marketing clearance for the use of its image management system with whole-slide imaging scanners from ...

NEW YORK – Tempus AI announced on Tuesday that it has partnered with Verastem Oncology to develop a companion diagnostic test for an ovarian cancer combination treatment. Tempus completed confirmatory ...

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.

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