Profiling Pathogens for Public Health
Genomic epidemiology can provide insights into pathogen transmission and evolution—and facilitate better countermeasures against infectious disease.
The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
CDC Calls Continued Rise in Cases of STIs “Alarming”
Health inequities and disrupted STI testing and care during the pandemic continued to contribute to a rise in cases in 2021.
The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
Senators to HHS: Keep Covering At-Home COVID-19 Tests After PHE Ends
Group of 18 senators says ending Medicare coverage for at-home COVID-19 tests would undo efforts to contain spread of the coronavirus.