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Group K said that the partners are developing a RT-LAMP system for use at the point of care in resource-limited areas where real-time RT-PCR is not available.

Members of the FDA, CDC, and CMS, comprising the Tri-Agency Task Force for Emergency Diagnostics, will work together to quickly respond to public health needs.

Proficiency testing providers told CMS last year that an update to the rule, which has not been changed since 1992, is long overdue.

A deep analysis of data from drug tests performed at Quest over the past six years has helped the company identify which drug tests are needed by clinicians.

CAP will work with the CDC and others to develop, publish, and encourage adoption of technical solutions for cancer and biomarker electronic reporting.

The blood test provides a simple alternative to complex methods of insulin resistance testing used primarily for research, the company said.

The CDC is leading the way to discover what causes the polio-like syndrome, as hospital labs also continue testing patient samples. 

HP said it will coordinate with the CDC to first evaluate inkjet printing technology in regional labs and later explore a larger rollout in labs nationwide.

Selected companies developing innovative technologies and products could receive breakthrough device designation and greater access to FDA guidance.

The workflow — which involves two immunoassays instead of the standard immunoassay followed by a Western blot — was tested using the agency's Lyme Serum Repository.

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