Neisseria gonorrhoeae (NG) is the second most commonly reported notifiable disease in the United States, with an estimated 820,000 cases annually. The current recommended regimen of IM ceftriaxone and oral azithromycin requires a second clinic visit and hence increases time to treat and limits the option for expedited partner treatment (EPT) and patient delivered partner therapy (PDPT), due to the logistics of injection. Additionally, super gonorrhea infections resistant to this last line of defense are beginning to emerge. For these reasons the World Health Organization has emphasized a pressing need for new drugs, as well as to seize the opportunities we have with existing drugs.
Roughly 70% of NG infections today are treatable with a single oral dose of ciprofloxacin.
Target-NG is a molecular test that determines ciprofloxacin susceptibility rapidly, rather than waiting for a culture result. Target-NG is offered as a reflex to Neisseria gonorrhoeae and Chlamydia trachomatis testing in Shield’s CLIA certified laboratory in San Jose, CA.Rates of ciprofloxacin resistance vary by state
|CIPROFLOXACIN||CEFTRIAXONE & AZITHROMYCIN|
|Single dose pill||
|IM Injection + pill|
|99.8% cure rate for sensitive infections||
|98-99% cure rate|
|Easy partner follow-up (EPT & PDPT available)||
|Limited ability for partner follow-up|
|Using up our last line of defense|
For ciprofloxacin-susceptible infections, our test allows simplified treatment with an inexpensive single-dose oral regimen, which is 99.8%+ effective. This reduces time to treat and boosts compliance, whilst also facilitating EPT & PDPT where recommended.
Our Target-NG test applies advanced molecular techniques to detect the presence or absence of mutations proven to cause ciprofloxacin resistance, and was found to have 100% sensitivity and specificity in a validation study of 26 clinical samples.
This methodology has been utilized successfully by the UCLA health system and has been part of a large-scale, NIH funded clinical trial.
In approximately 70% of cases, the last line antibiotics can be reserved for only those with infections truly requiring them. What’s more, ciprofloxacin achieves high tissue penetration which makes it particularly effective oral therapy in sensitive pharyngeal infections.
CT & NG testing is performed on pharyngeal, rectal and/or urine samples on the FDA cleared Hologic Panther and reflexed to our laboratory developed test for susceptibility testing. All tests are run in our world-class, CLIA certified, molecular diagnostics laboratory in San Jose, CA. Turnaround time is typically within 24 hours of receipt, including susceptibility testing.