NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA - POCTRN

null NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA

NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA

Ellume USA’s rapid at-home test was developed through the NIH RADx Initiative.


The U.S. Food and Drug Administration granted emergency use authorization (EUA) today for an innovative COVID-19 viral antigen test developed with support from the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Initiative. Ellume USA LLC, Valencia, California, designed the test for use at home without a prescription. This is the first EUA awarded for an at-home COVID test that can be purchased over the counter. Ellume developed the test with a $30 million contract and technical support from the RADx Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of NIH.

The test is performed using a mid-turbinate nasal swab designed for comfortable self-sampling.  The sample is inserted into a single-use cartridge that returns results in 15 minutes. The at-home test analyzer connects to the user’s smartphone through Bluetooth and pairs with a downloadable app that provides step-by-step instructions and displays results.

Users can share real-time results from the test, selling for approximately $30, with healthcare professionals, employers, and schools for efficient COVID-19 tracking. Ellume plans to scale-up manufacturing to deliver millions of home tests per month in 2021.

Read the full release here >

RADx: Rapid Acceleration of Diagnostics

In response to the COVID-19 pandemic, the Rapid Acceleration of Diagnostics (RADxsm) initiative was formed to accelerate the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect SARS-CoV-2, the virus that causes COVID-19.

ABOUT RADx

In the News 

Two New Over-the-Counter At-Home COVID-19 Tests Brought to U.S. Market Quickly by Biden-Harris Administration

New HHS actions add to Biden administration efforts to increase access to easy-to-use over-the-counter COVID-19 tests

NIH RADx initiative expands COVID-19 testing innovation for additional types of rapid tests

The need for new test verification and regulatory support for innovative diagnostics

NIH-funded screening study builds case for frequent COVID-19 antigen testing

RADx partnerships speed new COVID testing

One Year of RADx Tech Success

Publication reveals essential ingredients of the groundbreaking NIH RADx national diagnostics effort 

Innovative COVID-19 Testing RADx Tech Reports Unveiled in Special Issue of IEEE Open Journal of Engineering in Medicine and Biology

Luminostics Announces FDA Authorization and Production Scale-Up of US-Manufactured Smartphone-Based COVID-19 Rapid Test

RADx Expects COVID-19 Portfolio to Accelerate an Era of At-Home Infectious Disease Testing (Login Required)

VIC Foundry, Inc. Receives NIH RADx Funding for Development of an At-home Molecular Diagnostic Test for COVID-19

Ceres Nanosciences Opens Advanced Particle Manufacturing Plant in Northern Virginia to Expand Nanotrap® Particle Manufacturing Capacity for COVID-19 Testing

COVID-19 Testing: Three Breakthrough Solutions in the RADx Initiative

NIH Director: Collaboration Amid Chaos, and Biden’s First 100 Days - How Francis Collins sees the COVID response changing with the new administration

The National Strategy From the COVID-19 Response and Pandemic Preparedness

Winners of HHS Design-a-thon to Develop Innovative Digital Health Tools for COVID-19 At-Anywhere Diagnostic Tests Announced

The Need for More and Better Testing for COVID-19