Hologic receives FDA clearance for Mycoplasma genitalium assay – Medical Device Network

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Hologic has received clearance from the US Food and Drug Administration (FDA) to market its Aptima assay for the detection of the sexually transmitted infection (STI), Mycoplasma genitalium.

Aptima is said to be the first test approved to diagnose this STI, which is under-recognised but common.

“The infection is often misdiagnosed and can develop resistance to antibiotics if the wrong treatment is prescribed to a patient.”

Mycoplasma gentialium is the smallest known bacterium that can replicate. Patients infected with the disease often show no symptoms. If left untreated, it can result in infertility, miscarriage and premature birth in women and testicle pain, inflammation and sexually associated reactive arthritis in men.

The infection is often misdiagnosed and can develop resistance to antibiotics if the wrong treatment is prescribed to a patient.

The ribosomal RNA-based assay is expected to offer a highly sensitive and specific molecular diagnostic option for laboratories to detect infections and facilitate better treatment.

Hologic noted that the Aptima assay demonstrated greater sensitivity when compared to other lab-developed and CE-marked DNA-based tests.

Hologic research director Damon Getman said: “Although Mycoplasma genitalium is typically more common than gonorrhoea, 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.”

First discovered in the early 1980s, the STI was considered as an emerging public health threat by the US Centers for Disease Control and Prevention (CDC) in 2015.

Aptima Mycoplasma genitalium assay is part of Hologic’s Aptima STI portfolio, which includes tests for chlamydia, gonorrhoea, human papillomavirus (HPV), herpes simplex viruses (HSV 1&2), trichomonas and Zika virus.

The company also provides Aptima virology assays for HIV and hepatitis B and C (HBV and HCV).

Additional reporting by Charlotte Edwards. 



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