The days of a swab up the nose for COVID-19 testing are coming to an end with NOWDiagnostic's fingerstick test
The days of having a swab stuck up your nose for a COVID-19 test have come to an end.
A Springdale-based business, NOWDiagnostics, Inc., announced Wednesday it has received emergency use authorization for its ADEXUSDx COVID-19 antibody test that uses a drop of blood from a finger. The authorization is for use in moderate-complex settings and at the point-of-care from the U.S. Food and Drug Administration.
“The ADEXUSDx COVID-19 Test is literally a lab at the tip of your finger, specifically designed to make diagnostic testing possible at home," Kevin Clark, chief executive officer of NOWDiagnostics, Inc., said. "This EUA approval is the first step in making that a reality."
The rapid-results fingerstick test is the only emergency use authorized, self-contained assay available that measures the presence of COVID-19 antibodies to deliver "accurate, reliable, and affordable results in 15 minutes," according to a NOWDiagnostics. The performance of the test does not require a phlebotomist, buffers, reagents, or additional equipment.ADEXUSDx COVID-19 is specifically a COVID antibody test, a company spokesperson explains. So the test is not for active infection but can tell if a person has had COVID-19 and are potentially immune. Because it’s entirely self-contained, the test can be done on the spot without a doctor, pharmacist or other trained professional with specialty equipment. The test would also not need to be sent to a lab for processing.
During the emergency use authorization, however, it will only be used by trained professionals. The devices have been sent throughout the nation and NowDiagnostics in Springdale is on track to produce 2 million of the ADEXUSDx COVID-19 Test devices per month. The facility now employs about 95 people.
Development of the device began last spring when NowDiagnostics was working on similar fingerstick tests. They quickly changed focus to having the device detect the COVID-19 antibodies. Funding for the project has come from both local and national investors, Clark said. The company has 36 products in the pipeline now, including fingerstick tests for sexually transmitted diseases, food intolerance and strep throat.
"Think of it a cross between a urine pregnancy test and a glucose test," Clark said of the ADEXUSDx COVID-19 Test.
The company has 65 patents related to the device, which can also be used to test children. The goal, Clark said, is to get the cost of the device down to the price of a doctor's office co-pay.
It’s the only USA-made COVID antibody test, the company spokesperson added, and it targets antibodies to the spike protein of the SARS-CoV-2 virus. The current COVID-19 vaccines target the SARS-CoV-2 spike protein, so unless the antibody test is looking for antibodies to that protein, which the ADEXUSDx test does, the test results will have no meaning, the spokesperson noted. Some countries, including Israel, are requiring antibody tests to the spike protein as a condition for entering the country to check and see if a person has been vaccinated.
"A passport is not good enough anymore," Clark said, noting that the ADEXUSDx test could be used to clear travelers for entry into countries that require proof of COVID-19 resistance.
Following the emergency use authorization, NOWDiagnostics will begin offering the ADEXUSDx COVID-19 Test for use across a variety of Clinical Laboratory Improvement Amendments-waived health care settings including pharmacies, clinics, and hospital emergency rooms. This is while studies are ongoing to make the ADEXUSDx-patented technology available for over-the-counter detection of SARS-CoV-2 antibodies.
The application to use the ADEXUSDx COVID-19 Test for moderate complexity testing was originally submitted to the FDA in May 2020. In August 2020, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, provided funding and technical support to NOWDiagnostics for the development of the ADEXUSDx COVID-19 Test. Point of care (CLIA Waiver) performance data were subsequently submitted to the FDA in November 2020 to expand the use of the test.
Clark noted that the ADEXUSDx COVID-19 Test uses the same platform as their other FDA-cleared and/or CE marked, next-generation tests which are "affordable, portable, and deliver laboratory-quality results in minutes without any additional supplies."
Clark said they believe antibody testing is essential to America’s recovery from the COVID-19 pandemic, especially with the ongoing rollout of vaccines, and they're "proud to be responding to the urgent need for a reliable COVID-19 antibody test that targets the spike protein with our made-in-the-U.S.A. product.”
Developed and manufactured at NOWDiagnostics’ Springdale facility with materials sourced from American suppliers, the ADEXUSDx COVID-19 Test uses a drop (40 μL) of fingerstick or venous whole blood, serum, or plasma to identify individuals with SARS-CoV-2 antibodies.
U.S. Rep. Steve Womack, along with U.S. Sens. John Boozman and Tom Cotton, released the following statement regarding the announcement that NOWDiagnostics received an emergency use authorization from the FDA.
“Thanks to the incredible work of NOWDiagnostics, the only U.S.-made antibody test of its kind was developed and manufactured here in Springdale," the lawmakers said. "And while every Arkansan should be proud of our state’s contribution to America’s health, unfortunately, slow FDA approval prevented its earlier release. We will work together to ensure the FDA prioritizes a more efficient review process.”