DxLab Inc.

We have developed a new POC testing solution that utilizes a proven isothermal amplification technique, enabling highly accurate detection of targeted nucleic acids in as little as 10 minutes. Our testing solution does not involve any sample purification steps and instead works directly with crude specimens, simplifying sample collection and processing. The key feature of our solution is a portable, POC testing device with a small form factor (only weighing 5.1 lb.) that uniquely provides eight reaction chambers (i.e., test bays) that can be independently controlled in a random-access manner. Coupled with our “one-pot” assay design for simultaneous detection of targeted nucleic acids and control nucleic acid in a single reaction tube, our testing device enables up to eight samples to be tested at once on-the-spot. This testing throughput is several-fold higher compared to any existing POC testing systems (most of which can only test one sample at a time).

Key advantages of our solution include:
● Simple operation – Our test only involves four simple steps (sample collection, sample elution, sample transfer, device operation) without any need for expensive reagents or equipment for sample purification. The testing device provides clear on-screen instructions on how to run the test and automatically performs the amplification reaction on the samples. The device also performs signal processing and interpretation to provide unequivocal test results that do not involve any subjective signal interpretation. Various built-in controls in the test ensure that integrity of the amplification reaction is maintained, minimizing the rate of false-positives and false-negatives originating from various interfering sources.
● Proven device platform – Our testing device has been developed in partnership with Axxin, the ISO 13485 accredited experts in the development of diagnostic platforms. The device is built on the same core technology and platform that have been used in other FDA-approved in vitro diagnostic devices, such as Abbott’s ID Now device.
● Rapid testing time – Our testing solution provides a test result in 10-15 minutes for positive samples, 25 minutes for negative samples.
● Flexibility and adaptability – The core technology used in our testing solution is readily adjustable to target different nucleic acids, allowing for rapid development and deployment of new pathogen detection tests.
● High-throughput testing at the POC – Up to eight samples can be tested per device. Each of the test bays on our device can be controlled independently in a random-access manner, making it possible to test the samples sequentially or in parallel. This is especially useful in the POC settings, since samples can be tested as soon as they are collected, instead of waiting for all eight samples to be collected before running any test or waiting for previous sample testing to finish before starting the next test.

To confirm the capabilities of our solution, we designed our amplification reaction to target SARS-CoV-2, which could provide highly accurate detection of the virus on our testing device in as early as 10 minutes. This COVID-19 testing system received the emergency use authorization from the FDA.