RADX-TECH - LUMINOSTICS, INC. SMARTPHONE-BASED TEST FOR RAPID SARS-COV-2 ANTIGEN DETECTION FROM NASAL SWABS

Luminostics (San Jose, CA) is leveraging our de-risked and scale-ready smartphone-based diagnostics platform to develop a 15-minute smartphone-readout over-the-counter diagnostic self-test for the accurate detection of SARS-CoV-2 antigens from respiratory specimens (preferred sample type shallow nasal swab). We aim to obtain FDA EUA for this test by October 2020 and build a manufacturing capacity of >250k tests/week by November 2020. The assay & chemistry of this OTC test will be de-risked earlier through a a point-of-care version of the same product (EUA in July 2020).    Luminostics has developed a platform for high-sensitivity lateral flow immunoassays (LFAs) which is capable of orders-of-magnitude lower limits of detection (LoDs) compared to visually-read LFAsâ€"and therefore higher clinical sensitivities approaching RT-PCRâ€"using only a consumer smartphone’s optics, controlled by an app and paired with an inexpensive adapter, for readout. Our platform’s high sensitivity is enabled by the high detectability, with cheap optics, of our patented “glow-in-the-dark†persistent luminescent nanoparticles (“nanophosphorsâ€) in combination with highly optimized signal acquisition and processing algorithms. This means we can detect and quantify >100-fold lower levels of an analyte at the same per-test cost of a visual-readout LFA using the same affinity reagents, thereby enabling significant gains in clinical sensitivity. Our previous work has shown that this platform is ~90% sensitive and 99% specific for Chlamydia trachomatis detection compared to lab-based nucleic acid amplification testing methods in large clinical studies (N=437), enabling rapid, ultrasensitive, and portable diagnostics. We have also demonstrated superior anlaytical performance over existing rapid tests for other bacterial/viral pathogens.