Table 1.

FDA-approved (nonpanel) molecular tests per organism/organism group


Organism
Number
of Tests*

Organism
Number
of Tests*
Adenovirus3Influenza and respiratory viruses50
Bacillus anthracis1Leishmania spp.1
Bordetella spp.5Mycobacterium tuberculosis8
Candida spp.6Mycobacterium spp.9
Clostridium difficile17Mycoplasma genitalium1
Coxiella burnetii1Mycoplasma pneumoniae2
Chlamydia trachomatis/Neisseria gonorrhoeae47Nonvariola orthopoxvirus1
Cytomegalovirus5Norovirus1
Dengue virus1Plasmodium spp.1
Enterococcus spp.6Rickettsia spp.1
Enterovirus1Staphylococci19
Escherichia coli/Klebsiella pneumoniae/Pseudomonas aeruginosa1Streptococci21
Francisella tularensis1Shiga toxin1
Herpes simplex virus18Trichomonas vaginalis7
Hepatitis virus14Variola1
Human metapneumovirus3Yersinia pestis1
Human papillomavirus7

*Modified from www.fda.gov nucleic-acid–based tests.