Regulatory Focus™ > News Articles > 2019 > 5 > FDA Clears New Tests for Chlamydia, Gonorrhea, Zika Virus and Prosthetic Joint Infections

FDA Clears New Tests for Chlamydia, Gonorrhea, Zika Virus and Prosthetic Joint Infections

Posted 23 May 2019 | By Michael Mezher 

FDA Clears New Tests for Chlamydia, Gonorrhea, Zika Virus and Prosthetic Joint Infections

The US Food and Drug Administration (FDA) on Thursday cleared three new tests that can detect the presence of chlamydia and gonorrhea and authorized the marketing of a diagnostic to detect Zika virus immunoglobulin (IgM) antibodies in human blood.
 
The agency also authorized the first diagnostic to aid in detecting whether a patient has an injection around a prosthetic joint implant.
 
Hologic’s Aptima Combo 2 Assay and Cepheid’s Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of chlamydia and gonorrhea via the throat and rectum. Other tests were previously only cleared for testing urine, vaginal and endocervical samples.
 
“Prior to today, there were no chlamydia or gonorrhea tests cleared for use on samples from the throat and rectum. The availability of these two tests will fill an unmet public health need, by allowing for more screening,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health.
 
FDA also cleared InBios International’s ZIKV Detect 2.0 IgM Capture ELISA diagnostic via the de novo review pathway, making it the first Zika diagnostic cleared for use outside of an emergency use authorization. As the diagnostic is now fully authorized for use, FDA says it has revoked the EUA it issued for the test in 2016.
 
CD Diagnostics’ Synovasure Lateral Flow Test Kit was also cleared via the de novo pathway, becoming the first diagnostic cleared to detect whether inflammation around a prosthetic joint is due to an infection.
 
According to FDA, the test can aid physicians in diagnosing an infection around a prosthetic joint more quickly than other methods, which include reviewing X-ray images or conducting a laboratory analysis of joint fluid.
 
ZIKV Detect 2.0 IgM Capture ELISA
 
Aptima Combo 2 Assay and the Xpert CT/NG
 
Synovasure Lateral Flow Test Kit

Categories: Regulatory News

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