Makers of a new saliva Covid-19 test seeks EUA from FDA despite not needing it

A company with CLIA certification has developed a saliva test for Covid-19 and is asking for an Emergency Use Authorization from the Food and Drug Administration although it doesn’t need to use it on patients.

The average Joe/Jane/Jaswinder/Jaehee has never had to really contend with knowing the intricacies of Lab-developed tests (LDTs), CLIA waivers, FDA approved ones and all the different ways a test is developed. Now daily news about some new Covid-19 test or another and crackdowns on fake vaccines and tests have created a confusing scenario.  Add to that, companies that first announced the availability of at-home tests only to be forced to pause their plans to launch them once FDA warned that it hasn’t approved any at-homes Covid-19 tests.

As a result, one company is taking an interesting stance toward testing. Southwest Regional PCR Laboratory doing business as MicroGen DX is a laboratory that is CLIA-certified and therefore doesn’t need approval from the FDA to run a saliva test for Covid-19, which it has developed. The company claims that it is the first national laboratory to offer a validated Covid-19 test using saliva and sputum samples. But given the climate of confusion surrounding tests, it decided to ask the FDA for a EUA (emergency use authorization) for its PCR diagnostic assay despite not needing it.

On March 30, Chelsie Geyer, a microbiologist with the Office of In Vitro Diagnostics and Radiological Health from the FDA, sent a letter to the company saying “…EUA is not required for your assay at this time.”

Geyer made this determination based on FDA’s understanding that the MicroGencDX uses the “same primers/probes, positive/negative/extraction controls, and the same approach to interpretation as the CDC assay.”

MicroGenDX runs its Covid-19 Rapid PCR Test at its diagnostic laboratory in Lubbock Texas with a 24-hour turnaround from the time it receives a sample, according to a news release from the company. It has the ability to test 5,000 Covid-19 samples a day and hopes to be able to increase that to 10,000 per day in the future.

A spokeswoman for MicroGen DX confirmed that the company has completed actions suggested by the FDA that include performing a “bridging study to demonstrate similar LoDs when the assay is run with your modifications vs. according to the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.”  [LoD is short for “limit of detection” which refers to the smallest amount or concentration of analyte in the test sample that can be reliably distinguished from zero.]

FDA has gone on to list the MicroGen DX  among the labs that are currently offering validated Covid-19 tests (See Q3 on this page).

Despite the FDA’s support, the spokeswoman said that MicroGen Dx is still pursuing the Emergency Use Authorization.

“Currently, the lab is still seeking a formal EUA letter in an effort to thwart all confusion created by at-home test kits in particular in the recent weeks,” wrote Ashley Moore, in an email.

Source: FDA, Flickr