Bringing Precision Medicine to STIs

The CDC has declared antibiotic-resistant gonorrhea a top three urgent threat.

A New Paradigm for gonorrhea treatment

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 treatment, IM ceftriaxone and oral azithromycin, requires a second clinic visit, due to the logistics of injection. This will limit the option for expedited partner treatment (EPT) and patient delivered partner therapy (PDPT) and risks a delay in time to treatment compared to oral therapy. Super gonorrhea infections resistant to these treatments are beginning to emerge. As such, the World Health Organization is emphasizing the pressing need for new drugs, as well as maximizing the opportunities we have with existing drugs.

Target-NG for ciprofloxacin susceptibility

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.

Roughly 70% of US gonorrhea cases can be treated effectively with ciprofloxacin Rates of ciprofloxacin resistance vary by state

The Advantages of Cipro­floxacin for NG Treatment

CIPROFLOXACIN CEFTRIAXONE & AZITHROMYCIN
Single dose pill
vs
IM Injection + pill
High cure rate across sensitive infections
vs
High cure rate
Easy partner follow-up (EPT & PDPT available)
vs
Limited ability for partner follow-up
Antibiotic stewardship
vs
Using up our last line of defense
Inexpensive
vs
Very expensive

Precision Medicine

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.

Proven Technology for Accurate Results

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.

Antibiotic Stewardship

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.

N. gonorrhoeae (NG) and C. trachomatis (CT)

CT & NG testing is performed on pharyngeal, vaginal, 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.

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Questions?

Contact us at (669) 201-0321 info@shieldbio.com