MMWR Report on Gonorrhea and Chlamydia Incidence among MSM Spurs AHF to Call for FDA Approval of Newer Testing Technologies
Five City Study of At-risk Men-who-have-Sex-with-Men (MSM) Found that NAA (nucleic acid amplification) Testing—a More Accurate and Respected Test for Gonorrhea and Chlamydia—is Seldom Used, as it has Not Yet Been Cleared by the FDA for Such Purposes
AHF—A Clinical Participant in the Trial—Believes FDA Approval of NAA Testing for Gonorrhea and Chlamydia Could Also Help Reduce HIV Transmission among High Risk Populations
By: AIDS Healthcare Foundation
Los Angeles, CA - July 9, 2009
On the heels of the publication today of a landmark, five city US study of gonorrhea and Chlamydia infections and related testing protocols among populations of at-risk men-who-have-sex-with-men (MSM), the AIDS Healthcare Foundation (AHF)—a clinical participant in the research trial component in Los Angeles—today called on the Food and Drug Administration (FDA) to fast track approval of newer and alternative testing technologies highlighted in the study for use in the diagnosis of gonorrhea and Chlamydia infections among high-risk populations. The study, “Clinic-based Testing for Rectal and Pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis Infections by Community-based Organizations—Five Cities, United States, 2007” published in the respected Centers for Disease Control’s (CDC) Morbidity and Mortality Weekly Report (MMWR, July 9, 2009), found that one testing protocol, nucleic acid amplification (NAA), is, “…generally more sensitive and favored by most experts,” particularly for extragenital testing (for rectal and pharyngeal specimens); however, “NAA tests have not been cleared by the Food and Drug Administration (FDA) for the diagnosis…and may not be marketed for that purpose.”
“AIDS Healthcare Foundation was one of six community-based health organizations serving men-who-have-sex-with-men that participated in this study under Dr. Jeffrey Klausner’s stewardship. The results of this study are pretty straightforward, and we believe suggest simple, but prudent changes in the approval of such testing protocols by the FDA,“ said Homayoon Khanlou, MD, Chief of Medicine, US, for AIDS Healthcare Foundation. “Today, testing for both gonorrhea and Chlamydia can also be done by culture and by nucleic acid amplification. This study has shown that there are better, quicker returns and rates with NAA testing versus cultures, with NAA test results often available within 48 hours, while results of cultures are generally not available within that same timeframe.”
The study also noted that, “Manufacturers of NAA tests should pursue FDA clearance of those tests for the diagnosis of rectal and pharyngeal gonorrhea and chlamydia by gathering and submitting to the FDA sufficient data on test performance for those indications. In the interim, CDC and the Association of Public Health Laboratories can further help support increases in NAA testing by providing technical assistance and specimens to laboratories for use in verification studies,” and that, “…community-based organizations increasingly can be effective partners in the STD prevention efforts to control rectal and pharyngeal gonorrhea and Chlamydia, and possibly reduce HIV transmission in MSM.”
“We know that that gonorrhea or Chlamydia infections can be significant co-factors in the transmission of HIV,” added AHF’s Khanlou. “Presently, the CDC recommends a minimum of annual routine testing for gonorrhea and Chlamydia for at-risk MSMs. Looking at this study, we now strongly urge the FDA to fast track approval of NAA testing for gonorrhea and Chlamydia from rectal and pharyngeal specimens to streamline and improve testing for both of those diseases which, in turn, may also contribute to a reduction in the transmission of HIV infections among at-risk individuals who could also have either of those other STDs.”
