Laboratory

The ability to view laboratory results, track symptoms and sharing them with a provider were rated as the most useful potential app functions by patients with rheumatic and musculoskeletal diseases, according to data.

The FDA proposed a rule today to start regulating laboratory developed tests to ensure test safety and effectiveness, the agency said in a press release on Friday.

FDA announced the creation of a voluntary pilot program that will assist clinicians in selecting the appropriate treatment for patients with cancer through the use of laboratory-developed tests, according to an FDA press release.

Ascend announced the opening of a new laboratory in Sunnyvale, California, for testing services specific to kidney disease, according to a press release.

SYNAPS Dx has announced the opening of a new laboratory to support the launch of DISCERN, a minimally invasive diagnostic test to identify Alzheimer’s disease in people with dementia.

CareDx Inc. announced in a press release that its AlloMap Kidney completed the Clinical Laboratory Improvement Amendments validation, allowing it to move forward for a commercial launch.

A new BP control laboratory utilizing the national Patient-Centered Outcomes Research Network, or PCORnet, has the potential to improve surveillance of patients with hypertension and enhance comparative effectiveness research on the topic, according to a presentation at the American Heart Association Epidemiology, Prevention, Lifestyle and Cardiometabolic Health Scientific Sessions.

The FDA announced it issued a warning letter to Mylan Laboratories Limited over violations of current good manufacturing practice observed during an inspection of a drug manufacturing facility in India.