The agency said that it will during emergencies balance the risks of delaying access to tests compared with the risks of harm from inaccurate test results.

The agency said that it will during emergencies balance the risks of delaying access to tests compared with the risks of harm from inaccurate test results.

The companies will initially focus on the development of companion diagnostics that can be used in research and clinical trials in collaborations with pharma companies.

AD, the test measures epigenetic markers in mitochondrial DNA to assess the likelihood that a person with mild cognitive impairment will progress to dementia.

Helio Diagnostics will help with feasibility and development, performance verification, analytical and clinical validation, industrialization and tech transfer, and more.

Last week, readers were most interested in a story about the lack of evidence to support the widespread use of multi-cancer screening tests.

Stakeholders noted that challenges like supply chain breakdowns and staffing shortages are too global in scope for any one ...

The new rule, which went into effect Sept. 19, returns FDA's regulations on in vitro diagnostics to their previous form, which did not explicitly give FDA authority over LDTs.

The facility is expected to allow Hemex to scale up access to its point-of-care sickle cell diagnostic testing platform in high-burden countries.

The company's Liaison TSH-R Ab assay is used to aid the diagnosis of the autoimmune disorder Graves' disease and monitoring of treatment effectiveness.

Stakeholders noted that challenges like supply chain breakdowns and staffing shortages are too global in scope for any one laboratory to effectively prepare for on its own.