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

Luminostics （San Jose， CA）正在利用我们的低风险和规模就绪的基于智能手机的诊断平台，开发一种15分钟的智能手机读出非处方诊断自我检测，用于准确检测呼吸道标本（首选样本类型浅鼻拭子）中的SARS-CoV-2抗原。我们的目标是在2020年10月之前获得该测试的FDA EUA，并在2020年11月之前建立每周50万25万次测试的生产能力。通过同一产品的即时护理版本（2020年7月的EUA），该OTC检测的分析和化学将更早地降低风险。Luminostics开发了一种高灵敏度横向流动免疫测定（LFAs）平台，与视觉读取的lfas<e:2>相比，该平台能够具有数量级的低检测限（LoDs），因此临床灵敏度接近rt - pcr <e:2> -仅使用消费者智能手机<e:2>的光学器件，由应用程序控制并与廉价适配器配对，用于读出。我们的平台的高灵敏度是通过高可探测性，与廉价的光学元件，我们的专利<s:2>€œglow-in-the-darkâ€持久发光纳米粒子（<e:2>€œnanophosphorsâ€）结合高度优化的信号采集和处理算法实现的。这意味着我们可以使用相同的亲和试剂，以相同的单次检测成本检测和量化100倍低水平的分析物，从而显著提高临床灵敏度。我们之前的工作表明，与大型临床研究（N=437）中基于实验室的核酸扩增检测方法相比，该平台对沙眼衣原体检测的灵敏度约为90%，特异性为99%，实现了快速、超灵敏和便携式的诊断。我们还展示了比现有的其他细菌/病毒病原体快速检测更优越的分析性能。

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 LFAs—and therefore higher clinical sensitivities approaching RT-PCR—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.