Hologic Receives FDA Approval for Aptima® Mycoplasma genitalium Assay, the First and Only Diagnostic Test for This Emerging STI in the U.S.

VCBeat (WeChat Official Account: vcbeat) has learned that Hologic (Nasdaq: HOLX) recently announced that its Aptima® Mycoplasma genitalium assay has received approval from the U.S. Food and Drug Administration (FDA). This marks the first and only FDA-approved test for this sexually transmitted infection (STI). Mycoplasma genitalium infections have become increasingly prevalent yet remain underrecognized. The latest Aptima assay complements Hologic’s existing portfolio of industry-leading tests, aiming to help address the growing burden of sexually transmitted infections in the United States.

Mycoplasma genitalium was first discovered in the early 1980s and was listed as an emerging public health threat by the U.S. Centers for Disease Control and Prevention (CDC) in 2015. Due to the lack of FDA-approved tests to date, M. genitalium infections are often misdiagnosed as other sexually transmitted infections, and in some cases, infected individuals are incorrectly treated with antibiotics. This typically fails to control the underlying infection and instead leads to increased transmission and cross-infection.

“Although Mycoplasma genitalium is more common than gonorrhea, public awareness of this sexually transmitted infection remains low, which can lead to serious health problems,” said Dr. Damon Getman, Senior Principal Research Scientist and Director at Hologic. “The introduction of the Aptima Mycoplasma genitalium assay provides healthcare professionals and patients with optimal conditions for care, further demonstrating Hologic’s commitment to innovative solutions that address emerging public health threats.”

In men, symptoms of Mycoplasma genitalium infection may include urethritis, urethral swelling, and other inflammatory conditions. In women, M. genitalium is associated with cervicitis and cervical swelling; if left untreated, the infection can lead to infertility and increase the risk of acquiring and transmitting HIV. Some individuals infected with M. genitalium may remain asymptomatic or present with symptoms similar to those of chlamydial infection, making accurate diagnostic testing crucial for identifying the bacterial infection and initiating appropriate treatment. Studies indicate that up to 50% of infected women and 42% of infected men may harbor antibiotic-resistant strains, further underscoring the importance of early detection and regular screening.

“The team of scientists and engineers who developed this analytical method is dedicated to helping laboratories and healthcare professionals use optimal diagnostic tools to identify harmful infections,” said Tom West, President of Hologic’s Diagnostic Solutions segment. “FDA clearance is another milestone in advancing this technology and mission.”

Hologic Official Website – Testing Tools Introduction Page

Studies have shown that Hologic’s ribosomal RNA-based assay for *Mycoplasma genitalium* demonstrates higher sensitivity than DNA-based testing platforms. Leveraging its innovative RNA-based technology, Hologic launched the first FDA-approved diagnostic kit for sexually transmitted infections (STIs) in the 1990s. Since then, Hologic has expanded its Aptima STI portfolio to include assays for *Chlamydia*, *Gonorrhea*, human papillomavirus (HPV), herpes simplex virus (HSV-1 and HSV-2), *Trichomonas vaginalis*, and Zika virus. In 2017, Aptima assays helped approximately 40 million patients obtain rapid, high-quality test results.

Founded in 1985, Hologic is an innovative medical technology company primarily dedicated to improving women’s health and well-being through early detection and treatment. Hologic’s Panther and Panther Fusion® systems offer 14 FDA-cleared or approved assays, covering more than 20 common pathogens.

Now, Hologic has become the only high-throughput molecular diagnostics platform in the United States that integrates ten medical testing categories—including comprehensive health, cervical health, viral load, respiratory testing, and open-channel assays—into a single fully automated system.