5-Minute Multiplex PCR Testing System to Redefine Point-Of-Care Diagnostics

Point of care (POC) testing provides significant clinical benefits, particularly when results can be obtained quickly enough to inform clinical decisions during a single consultation, eliminating the need for follow-up visits. Such rapid diagnostics can significantly reduce costs by minimizing both the number of patient-clinician interactions required for diagnosis and treatment decisions and the need for patients to make multiple trips to the healthcare facility for a single episode of illness. Typically, POC molecular diagnostic tests can produce results within about an hour. Now, a low-cost instrument aims to redefine POC diagnostics by delivering molecular tests at the time they are most needed.

LEX Diagnostics (Melbourn, UK) is developing a PCR molecular system that offers both high speed and high sensitivity, capable of completing a test in less than 10 minutes and reporting positive results in as little as 5 minutes. This ensures that results are available quickly enough to impact clinical decisions within the same appointment. The LEX system is designed around a cartridge that receives a dry swab and conducts all necessary sample preparation, processing, and analysis internally, without the need for manual sample elution or other preparatory steps. This design not only speeds up the process but also confines all sample handling within the system, reducing the manual effort required and minimizing the exposure risk for healthcare workers.

The device's ability to provide rapid yet sensitive PCR testing is facilitated by innovative thermal cycling technology and proprietary LEX reagents. Unlike traditional systems that rely on Peltier devices, which can be costly and less reliable, LEX’s patented thermal cycler technology allows for extremely quick heating and cooling, maintaining precise thermal control. This capability ensures that enzyme-driven amplification processes are optimized for speed without sacrificing sensitivity, making rapid PCR diagnostics feasible at the POC. The LEX system is suitable for settings with a CLIA waiver, including urgent care centers, pharmacies, and physician offices.

The LEX system is capable of delivering positive results in just 5 minutes and can perform multiplex testing to identify and differentiate between Flu A, Flu B, and COVID-19. Negative results are delivered in under 10 minutes. LEX is also planning to expand its range of respiratory tests to include rapid assays for RSV and Strep A, which are expected to be completed in about 5 minutes. With the development of its second-generation instrument, LEX aims to add testing for sexually transmitted infections (STIs) to its portfolio.

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