Medical technology firm Hologic has secured approval from the US Food and Drug Administration (FDA) for its Aptima Mycoplasma genitalium assay.
Aptima is said to be the first and only FDA-cleared test to detect the under-recognized and common sexually transmitted infection (STI).
Approved via FDA’s de novo request process, the firm’s first-in-category assay serves as a highly sensitive and specific molecular diagnostic method for laboratories to detect infections and provide better treatment.
Mycoplasma genitalium (M. genitalium), which was first discovered in the early 1980s, was recognized as an emerging public health threat by the US Centers for Disease Control and Prevention (CDC) in 2015.
Hologic senior principal research scientist and research director Dr Damon Getman said: “Although Mycoplasma genitalium is typically more common than gonorrhea, there is very little public awareness of this rising sexually transmitted infection, which can cause serious and potentially devastating health problems.
The introduction of the Aptima Mycoplasma genitalium assay gives healthcare professionals the opportunity to provide optimal care for their patients and reflects Hologic’s commitment to developing innovative solutions that address emerging public health threats.”
The symptoms of M. genitalium in man include urethritis, which is the swelling and inflammation of the urethra. Its symptoms in women include cervicitis, which is the swelling and inflammation of the cervix.
According to the company, the ribosomal RNA-based M. genitalium assay showed greater sensitivity than lab-developed or CE-marked DNA-based tests in published research.
During 1990s, Hologic launched first FDA-cleared diagnostic test kit for STIs, which is developed by using RNA-based technology.
The firm’s other Aptima STI products include assays for chlamydia, gonorrhea, human papillomavirus (HPV), herpes simplex viruses (HSV 1&2), trichomonas, and Zika virus
Aptima virology portfolio is comprised of quantitative assays for the human immunodeficiency virus (HIV) and hepatitis B and C (HBV and HCV). All assays can be run on fully-automated Panther system.
Hologic diagnostic solutions division president Tom West said: “They exemplify Hologic’s dedication to help arm laboratories and healthcare professionals with superior diagnostic tools to identify harmful infections, and this FDA clearance represents another milestone in furthering that mission.”