FDA Authorizes First COVID-19 Diagnostic Test for Individuals Without Symptoms

On July 24, the FDA authorized its first COVID-19 diagnostic test for people who haven’t shown any symptoms. This form of broad-based screening is meant to test individuals who don’t suspect that they’ve come into contact with anyone with the disease. 

Since testing efforts began, diagnostic tests had been reserved for individuals with telltale symptoms of a COVID-19 infection, such as fever and dry cough. Efforts had also been targeted toward high-risk populations, including the immunocompromised and front-line healthcare workers. 



The FDA issued an emergency use authorization (EUA) for LabCorp’s RE-PCR Test, which now includes testing asymptomatic COVID-19 carriers. 

The EUA also gives the green light for pooled sample testing, a technique by which multiple samples can be evaluated as a single test. Individual tests are performed should the group test reveal a positive result. 



Asymptomatic spread has been a particularly difficult challenge to overcome. LabCorp’s test is a step toward preventing outbreaks while conserving testing manpower and resources. The test may even provide the threshold of certainty required to reopen businesses, schools, and other organizations. 

LabCorp’s CEO Adam Schechter revealed that COVID-19 is spreading faster than the company can keep up, lengthening turnaround times for results. The company is currently processing more than 160,000 tests per day, amounting to over a million each week. 

The company has expanded its testing capacity by just over 8 times since the early stages of the pandemic during late March. The problem is that the number of cases in the US is outrunning the number of tests the company can produce within an effective time frame. 

For individuals who aren’t in the hospital, turnaround time should be within the range of 2 to 3 days. The sooner a carrier is identified, the easier it is to trace the people they’ve been in contact with. Average turnaround time currently is roughly 3 to 5 days. 

Batch testing may be the strategy we need to get ahead of asymptomatic transmission. This approach was first FDA-approved for Quest Diagnostics in the second last week of July. Quest Diagnostics and LabCorp account for more than half of commercial testing efforts in the US. 

There is one caveat. Because positive results are buried within a group, batch testing works best in areas of low prevalence. However, COVID-19 surges are occurring across the country, with tens of thousands of new infections cropping up every day. The total number of confirmed cases jumped from 3 to 4 million in just two weeks.