Laboratory-developed Tests: An Uncertain Path
HPAI. Measles. Oropouche. Dengue. With new and re-emerging biological threats in full swing, public health laboratories have been responding using testing that has been developed in real-time. With LDT regulations recently introduced by FDA, the expectation is that public health laboratories will continue to develop tests, but innovations and responses will slow as the regulatory system is established by federal partners for a more "one size fits all" approach. How are public health laboratories adapting?
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