15-Minute Multiplex Molecular Tests to Detect STI at Point-of-Care

Annually, between 35 and 50 million tests for chlamydia and gonorrhea are conducted in the United States, largely driven by guidelines recommending annual STI screenings for many sexually active individuals and even more frequent tests for specific high-risk groups. Despite these recommendations, about half of the women eligible for screening do not undergo proper testing each year, leading to significant undertesting. Additionally, the time delay in lab-based testing can result in patients remaining untreated and potentially spreading infections, or in preemptive treatments based on best guesses that may be inappropriate, causing unnecessary costs, side effects, and potential development of antimicrobial resistance. Now, a new rapid, portable molecular STI test promises to deliver immediate results to patients and providers, enabling prompt treatment and potentially improving health outcomes, especially for patients who might otherwise postpone or forego testing.

Detect (Guilford, CT, USA) is gearing up to begin clinical validations for its 15-minute multiplex molecular STI test, based on a technology initially developed for tackling the COVID-19 pandemic. This testing relies on loop-mediated isothermal amplification (LAMP) and a simple instrument, aiming for affordability, speed, and ease of use. The instrument performs parallel reactions for quick multiplexing, as opposed to single-tube reactions. While LAMP is a widely used technology, Detect has enhanced it considerably in recent years. Challenges in LAMP for diagnostics developers, such as primer design and reaction speed, have been addressed by Detect's use of AI-based primer design tools to develop highly sensitive and specific tests. The tests also incorporate proprietary biologics like enzymes, which are self-designed and manufactured by Detect, leading to faster and more accurate results.

Detect has leveraged the same technology used for its COVID-19 test to expand its applications and upgrade the system, making it faster, more user-friendly, and more sensitive. This evolution has resulted in an advanced point-of-care system and new multiplex molecular tests. The company is now advancing its initial isothermal multiplex panel for STIs. Dealing with STI testing presented a unique challenge in sample preparation, as vaginal matrix samples, unlike saliva or nasal secretions, require additional preparation steps to make pathogens accessible. Detect has addressed this major technical hurdle by creating a cost-effective, miniaturized sample preparation component for its system. The test cartridge itself is composed of simple plastic fluidic components, shifting complex electronics or motors from the cartridge to the hub, thus reducing the cost of the cartridge.

Detect's primary market includes point-of-care testing locations like doctors' offices, urgent care clinics, nursing homes, and pharmacies, which are typically more concerned with the ongoing cost of consumables rather than the initial cost of the testing device. The company anticipates its platform to be substantially more affordable than other point-of-care systems currently on the market. Detect is focusing on validating its rapid molecular STI assay in the coming months to prepare for submission to the US Food and Drug Administration. In the future, Detect plans to enhance its STI panel to identify specific SNPs in gonorrhea bacteria that render them resistant to ciprofloxacin, a low-cost antibiotic.