In response to the rising challenge of drug-resistant gonorrhea, Prompt Diagnostics is set to revolutionize STI treatment with a portable PCR-based test designed to provide rapid drug susceptibility information. This test aims to expand treatment options and improve patient outcomes.
Baltimore-based Prompt Diagnostics, a Johns Hopkins University spinout, has developed this test in collaboration with Novartis Pharma AG. The portable, rapid, on-cartridge magnetofluidic purification and testing (PROMPT) platform aims to make testing more accessible and affordable. The company recently secured a $1 million grant from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). This funding will support the development of tests to detect gonorrhea and assess its susceptibility to antibiotics like ceftriaxone and ciprofloxacin.
Prompt’s new test can identify the S91F mutation in the N. gonorrhoeae gyrA gene associated with ciprofloxacin resistance. This could reintroduce ciprofloxacin as a viable treatment option for many cases of gonorrhea. Gonorrhea, a major public health concern, affects millions worldwide, with a significant number of cases in underserved regions. The World Health Organization has set a goal to reduce N. gonorrhoeae infections by 90% by 2030, highlighting the need for improved diagnostic tools.
In a 2021 study, the cartridge-based test demonstrated 97.7% sensitivity and 97.6% specificity for detecting infections, with 100% concordance for ciprofloxacin resistance. The prototype platform, roughly the size of a mobile phone, can run multiple tests on a single charge, making it ideal for use in various settings, including low-resource areas.
The CARB-X grant will help transition the prototype to a manufacturable device and ensure the cartridges are shelf-stable and scalable. Prompt aims to begin manufacturing in 2025, with clinical studies to follow. The company targets a market launch by 2026 or 2027, focusing first on the US market to gain FDA clearance before expanding globally.