FDA Approves the First Product for Diagnosis of Mycoplasma Genitalium
Recently, the FDA approved the first product for diagnosing Mycoplasma genitalium. Mycoplasma genitalium being detected is a sexually transmitted infection (STI), which is increasingly common but not fully recognized by the public. Aptima Mycoplasma genitalium test developed by hologic, an innovative medical technology company, is the first product of its kind approved by the FDA.
Mycoplasma genitalium is unfamiliar to many people and even many doctors, but Mycoplasma genitalium infection is more common than gonorrhea. In the United States, for example, about 15-30% of male urethritis and 10-30% of female cervicitis are caused by this bacterium. If not treated, it may lead to infertility in women with infection. In 2015, Mycoplasma genitalium was listed as a new public health threat by the CDC in the United States.
Because there was no reliable detection method in the past, Mycoplasma genitalium infection was easily missed or misdiagnosed as other bacterial infection. In some cases, patients get the wrong antibiotic treatment, which leads to increased transmission and recurrence of infection. At the same time, it may cause more and more serious drug resistance of this microorganism.
The approved aptima for diagnosing Mycoplasma genitalium is a nucleic acid amplification test for hospital use. It is a molecular diagnostic tool with high sensitivity and specificity to detect Mycoplasma genitalium in urine, urethra, penile tip, cervical, or vaginal swabs.
The approval was based on clinical studies involving 11774 samples. The data showed that the best clinical performance was obtained by using vaginal swabs, with an accuracy of 90%. The recognition accuracy of male urethra, urine and penis mouth samples was also 90%, and that of female urine and cervical samples was 77.8% and 81.5%, respectively. In addition, the accuracy of all kinds of negative samples was 97.8-99.6%.
"With accurate and reliable detection methods to identify what kind of bacteria causes the infection, doctors can prescribe the right medicine, thus reducing the abuse of antibiotics and helping to solve the problem of drug resistance." Dr. Scott Gottlieb, FDA director, said.
Especially for the patients who still have uncomfortable symptoms after antibiotic treatment, it is of little significance to treat them with antibiotics at this time. Fuyan Pill and Diuretic and Anti-inflammatory Pill, herbal medicines with functions of clearing away heat and toxin, promoting blood circulation and removing blood stasis, and invigorating spleen and removing dampness, can be used to treat not only Mycoplasma infection but also enhancing patients' immunity through comprehensive conditioning.
Besides, it can help treat the complications, removing the focus thoroughly, and preventing the recurrence of Mycoplasma. Moreover, because the medicine is made up of natural herbs with reasonable compatibility, the usage and dosage are also strict, there will not be any side effects or drug resistance even if patients take it for a long time.
