The U.S. Food and Drug Administration has approved the marketing of two extragenital diagnostic testings for the sexually transmitted infections chlamydia and gonorrhea.
FDA Clears 2 New STI Testing Devices
The Aptima Combo 2 Assay and the Xpert CT/NG can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonnorrhoeae through the examination of extragenital specimens. The two devices are the first to be cleared for the testing of these infections using samples from the throat and the rectum.
"The availability of these two tests will fill an unmet public health need, by allowing for more screening," stated Tim Stenzel from the FDA's Center for Devices and Radiological Health. "It is best for patients if both of these sexually transmitted infections are caught and treated right away, as significant complications can occur if left untreated."
The decision, which was announced on Thursday, May 23, is based on the clinical data collected through a cross-sectional study of both devices. The multi-site trials involving 2,500 patients evaluated and proved the safety and accuracy of the devices.
The clearance was granted to Hologic, Inc. (Aptima Combo 2 Assay) and Cepheid (Xpert CT/NG).
Prior to the new devices, testing for chlamydia and gonorrhea were only made using urine, vagina, and endocervical samples.
Sexually Transmitted Infections Steadily Increasing
The approval of the two extragenital diagnostic testing devices should help curb the increasing number of new cases of sexually transmitted infections in the United States. According to the data by the Centers for Disease Control and Prevention, there is an estimated 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea across the country in 2017 alone.
Both chlamydia and gonorrhea are spread through sexual intercourse, including anal and oral contact. Both are also very treatable with medicine, especially when caught early. However, when left untreated, sexually transmitted infections could lead to serious complications such as infertility for both men and women.
Often, people infected with chlamydia and gonorrhea do not experience any symptoms. Most of the time, people who do have it are not aware that they are infected. That is why both infections are very common in the United States.
The public health experts recommend regular screening for STD, even if no symptoms manifest.