The portable test from Visby Medical will be able to detect gonorrhea and assess susceptibility to ciprofloxacin.
The low-cost lateral flow assay showed high sensitivity and specificity in 400 patients with symptoms of gonorrhea, and results were available in 30 minutes.
Health officials say the STI epidemic is at a tipping point, with more federal support needed for testing and treatment.
Intravacc will receive an award of $633,000 to develop its meningococcal outer membrane vesicle vaccine for preventing gonorrhea infections.
The FDA said the test offers a private and quick testing option, along with streamlined treatment, if needed.
Most of the newly affected Finnish farms raised foxes, but some also produced raccoon dogs.
The investigational oral antibiotic zoliflodacin would be the first new treatment for gonorrhea in decades.
The vaccine targets outer membrane vesicles that are common to both Neisseria meningitidis and Neisseria gonorrhoeae.
Gonorrhea infections in China are showing decreasing susceptibility to ceftriaxone along with high levels of resistance to other antibiotics.
The designation means that the NgG vaccine, which is in a phase 2 trial, will receive expedited review by FDA officials.
