Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Aptima® Mycoplasma genitalium assay, the first and only FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection (STI). This newest Aptima assay joins a growing suite of market-leading tests offered by Hologic to help combat the rise of STIs in the U.S. Hologic’s first-in-category assay, cleared through the FDA’s De Novo request process, provides laboratories with a highly sensitive and specific molecular diagnostic method to identify infections and enable effective treatment. First discovered in the early 1980s, Mycoplasma genitalium (M. genitalium) was listed as an emerging public health threat by the U.S. Centers for Disease Control and Prevention (CDC) in 2015.