Company seeks Emergency OK from FDA for blood drop test

Springdale-Based NOWDiagnostics is seeking FDA approval for a rapid COVID-19 antibody test developed in their labs. The test is called the ADEXUSDx COVID-19 Antibody Test.

NOWDiagnostics, or NOWDx for short, have worked on the antibody test since February.

The testing company calls the test a simple, affordable, portable test. The tests using a small drop of blood take anywhere from 10 to 15 minutes to reveal results.

The Emergency Use Authorization from the FDA has a lower threshold for test approval, however NOWDiagnostics is confident they have achieved success well beyond the threshold required.

NOWDiagnostics said it has worked with various health departments, best-in-class national facilities, hospitals, and laboratories. Through the cultivation of a geographically diverse pool they ensured their COVID-19 test would be sensitive enough to pick up a wide variety of blood samples and types.

“This platform is really the first Ive seen [that] it’s simple enough that everyone can do the test, and yet sensitive enough to give us laboratory quality results.” Kevin Clark, CEO of NOWDiagnostics said.

The test is currently being evaluated at the National Cancer Institute, and the Mayo Clinic as well.

“You can become infected tomorrow, even PCR (polymerise chain reaction) testing won’t pick up a positive, or won’t be able to pick up that you’ve been infected or exposed for three or four days, and the antibodies usually start by the time the symptoms start, so really with any kind of imaging test the only answer is more testing.” Clark said.

For those who may not know what PCR testing is, “At the moment the majority of the current COVID-19 tests that all the reports are coming from are using PCR,” says University of Sussex senior lecturer in microbiology Dr Edward Wright. “They detect the genetic information of the virus, the RNA. That’s only possible if the virus is there and someone is actively infected.”

PCR tests are used to detect the presence of an antigen, rather than the presence of the body’s immune response, or antibodies. By detecting viral RNA, which will be present in the body before antibodies form or symptoms of the disease are present, the tests can tell whether or not someone has the virus very early on.

“If there’s a chance of exposure, you test, you test three days later, five days later. Most people if they’ve been exposed they show symptoms in the five to seven day window, and that’s the time that you really have to keep testing.” Clark said.

NOWDiagnositcs is also developing a rapid saliva test to detect active COVID-19 viruses and antibodies. Development has been approved by the FDA