The home and point-of-care testing platforms target the need for high-performance, low-cost home tests and point-of-care tests that can potentially detect multiple respiratory infections. The awards support the development, validation, scale-up and manufacturing with the goal of bringing needed tests to the market as early as this year.
The new awards are in addition to 33 that NIH previously disbursed through its technology development program. The RADx Tech program has resulted in 32 U.S. Food and Drug Administration emergency use authorizations (EUAs), including supporting the first EUA for a home test. Companies supported by the RADx program that achieved an EUA have contributed over 840 million tests to the U.S. market since fall of 2020.
Companies receiving support from the NIH include:
- Detect, Guilford, CT, for a rapid, reverse transcriptase-loop mediated isothermal amplification (RT-LAMP) platform with mobile app-guided instructions to detect SARS-CoV-2 in about 60 minutes.
- Palogen, Palo Alto, CA, for a nanoelectronic biosensor that detects SARS-CoV-2 RNA in three minutes.
- Quidel, San Diego, for a real-time PCR platform that simultaneously detects influenza A/B, respiratory syncytial virus and SARS-CoV-2 in less than 25 minutes.
- Uh-Oh Labs, Santa Clara, CA, for a portable and reusable RT-LAMP device with single-use cartridges that detect SARS-CoV-2 in 30 minutes.
- UCLA for a next-generation sequencing technology for COVID-19 testing that will be scaled up to help increase surveillance of cases and variants in the United States.
- Becton, Dickinson and Company (BD), Franklin Lakes, NJ, for two separate product lines to detect SARS-CoV-2 in 15 minutes or less. One is a lateral flow immunoassay with a reader that delivers electronic results intended to be used in point-of-care settings. The second is an at-home lateral flow test that is digitally read by a smartphone.
- Ellume USA LLC, Frederick, MD, for a single-use, digital fluorescent immunoassay antigen test for SARS-CoV-2 and influenza A/B all-in-one platform. Results are returned in 15 minutes or less.
- Luminostics (dba Clip Health), Milpitas, CA for a rapid, smartphone-connected, antigen immunoassay that uses glow-in-the-dark nanomaterials to detect and differentiate SARS-CoV-2 and influenza A/B.
- LumiraDx, Waltham, MA, for a microfluidic immunofluorescence assay that can detect SARS-CoV-2 and influenza A/B expected to have sensitivity approaching laboratory PCR. Multiplexed assay results are provided in less than 15 minutes. The test is intended for use in point-of-care settings.
- Princeton BioMeditech, Monmouth Junction, NJ, for a lateral flow assay antigen test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B all-in-one test.
