The proposed rule would amend CLIA to provide patients direct access to lab test reports and amend the HIPAA Privacy Rule to remove the exceptions that relate to CLIA ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

During the year, the industry saw continued consolidation, the end of a key advisory body, the rise in DTC testing and advanced diagnostics, and another stab at PAMA reform.

A laboratory test has confirmed that a diarrhoea outbreak, which has killed at least four patients and affected over 1,400 ...