25 January 2019 - - The US Food and Drug Administration has granted clearance for US-based medical technology company Hologic, Inc.'s (NASDAQ: HOLX) Aptima Mycoplasma genitalium assay, the first and only FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection, the company said.

This newest Aptima assay joins a growing suite of market-leading tests offered by Hologic to help combat the rise of STIs in the US.

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 US Centers for Disease Control and Prevention in 2015.

Current estimates indicate that M. genitalium may affect more than 15% of men and women in certain high-risk populations, and its prevalence is growing.

Because of the lack of an FDA-cleared test until now, M. genitalium has often been misdiagnosed as other STIs and, in some cases, treated with the wrong antibiotics. This often leaves the underlying infection untreated, which can lead to increased transmission and recurrent infections.

In men, M. genitalium symptoms may include urethritis, the swelling and inflammation of the urethra. In women, M. genitalium has been linked to cervicitis, the swelling and inflammation of the cervix.

If left untreated, infections can lead to infertility in women and increased risk of HIV acquisition and transmission.

Patients infected with M. genitalium may be asymptomatic or experience symptoms similar to those associated with a chlamydial infection, so accurate diagnostic tests are critical to help healthcare professionals and their laboratory partners identify these bacterial infections and treat them appropriately.

Research has shown as many as 50% of women and 42 % of men with M. genitalium may have an antibiotic-resistant strain, further emphasizing the importance of early detection and regular screening.

In published research, Hologic's ribosomal RNA-based M. genitalium assay displayed greater sensitivity than lab-developed or CE-marked DNA-based tests.

Hologic introduced the first FDA-cleared diagnostic test kit for STIs in the 1990s using its innovative RNA-based technology.

Since then, Hologic has expanded its Aptima STI portfolio to include assays for chlamydia, gonorrhea, human papillomavirus, herpes simplex viruses (HSV 1 and 2), trichomonas, and Zika virus. The Aptima virology portfolio also includes quantitative assays for the human immunodeficiency virus and hepatitis B and C (HBV and HCV). All are available on Hologic's fully-automated Panther system.

In 2017, the Aptima assays helped an estimated 40 m patients obtain fast, high-quality test results.

Including the first IVD for the detection of Mycoplasma genitalium, Hologic's Panther and Panther Fusion system now offers 14 FDA-cleared or approved assays that detect more than 20 pathogens, making it the only high-throughput molecular diagnostic platform in the United States to combine comprehensive sexual health, cervical health, viral load, respiratory testing and open channel10 functionality on a fully automated system.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment.