mLife Diagnostics LLC of Marshall announced that the U.S. Food and Drug Administration has granted Emergency Use Authorization, or EUA, for the mLife True saliva COVID-19 collection kit for testing at Express Gene Molecular Diagnostics Laboratory of Miami, Florida.
mLife CEO Alan Loudermilk said that this authorization allows any clinic in the country to utilize the new, and less invasive COVID-19 test created by the company.
“Basically, when the EUA is granted for one location, as long as you are doing the exact same thing as they are at the clinic with the EUA, it is counted under the EUA,” Loudermilk explained.
This authorization was granted by the FDA after collection of specimens to fulfill the FDA’s requirements was achieved through a clinical trial at Hospitality Health ER in Longview.
Loudermilk said he credits Hospitality Health ER for this important milestone in mLife’s COVID-19 testing program.
“I am in awe of the physicians, nurses and staff of Hospitality Health ER for the hard work and dedication that they demonstrated in caring for the many COVID patients that arrived at the ER during this pandemic. Our frontline medical workers in a time like this truly are heroes,” Loudermilk said. “Special thanks to Dr. Gene Kelly for his guidance and oversight and to Rehan Tariq for his helpful suggestions and exceptional work with the patients throughout the trial.”
Though the testing was delayed after FDA standards changed in the middle of the collection process, Loudermilk said that they were able to get authorization much faster than what is standard, due in part to the ongoing pandemic.
“Hospitality Health ER is focused on patient care, and we viewed this as an opportunity to help make a new COVID testing method available to patients here and across the country,” said Dr. Kelly.
Hospitality Health ER Vice President Jill Shipp said that they were very excited to participate in the testing process for the new kits, since their clinic has been on the front lines of the battle against COVID-19 since January 2020.
“We are a family owned company, so everything that we have done has really been grassroots, we don’t have a big corporation that supports us and backs us,” Shipp said. “So we were looking for someone to partner with. We really wanted someone who was doing something; we wanted someone to be aggressive.”
Both Shipp and Loudermilk credited Dr. Kelly’s drive to research COVID-19 and to do everything possible to assist in the fight against it, for the success of the testing process at Hospitality Health ER.
“It’s truly an honor to participate in something that is really making a difference. To know that the extra work that you put in now can really impact the millions of people in the future is amazing.” Shipp said.
The EUA expressly references testing at Express Gene Molecular Diagnostics Laboratory using the Thermo Fisher TaqPath COVID-19 Combo Kit. Loudermilk noted that other labs using the Thermo Fisher TaqPath Kit may also now provide testing services using the mLife True collection kit.
Loudermilk said that the company is still in the process of getting authorization for their version of the new saliva based kit that can be used for at home testing. This version of the kit will have a plastic vile, rather than glass, and a different type of liquid buffer as well.
The group’s first commercial shipment of the kits was on July 30, according to Loudermilk, who said that certain states do not require the EUA before clinics are allowed to utilize the new kits.
“We are supplying kits to the states of Michigan, Ohio and South Carolina currently. The State of Texas is likely to open up now, as they were waiting on the EUA from the FDA,” Loudermilk said.
The company currently has 100k kits available in Marshall to deliver to interested customers.
How the test works
Loudermilk previous explained that the kit works by taking the noninvasive saliva swab, which can be done by anyone, unlike the usual COVID-19 test that requires a medical professional.
The kit then instructs users to firmly grip the mLife True collector tube in one hand with the bottom of the tube positioned on a firm surface. The saliva swab is then inserted into the vial to be sent to the labs.
And because the aim is to optimize the workflow for Corona, Loudermilk said his company created a buffer for the kit. This buffer will not be available in the at home kit, which is still in the works for FDA authorization.
Instead of the buffer, which Loudermilk said could be potentially dangerous if mixed with bleach, the at home kit includes robust tubes and tight caps that prevent any leakage from the samples.
“The first thing we did was we came up with this design, and then we also came up with a buffer, working with a partner that deactivates the virus,” Loudermilk said. “So, you have to assume everybody that you test is corona positive, so we assume that’s the case and we collect the specimen and deposit it in this vial. It has a viral deactivation, RNA preservation agent; so it kills the virus, but preserves its RNA, so that we can detect it.”
The sample is placed inside of a specimen bag, and triple bagged for further security.
It has a vial and a special preservative, and the specimen is delivered the next day to a lab with a capped bottle (resolving potential leak problems with other collectors). The current test is for the detection of the virus based on viral RNA detection. Antibody tests using the mLife True kit are under development. Results are expected within about 24 hours.
Loudermilk said that this new test design is simple, and is the perfect replacement for the more invasive sinus test, especially for those who get tested frequently.
“Now a days there are people who get tested every day, because they have to for work, or for sports, there are certain office buildings that won’t let you in without a test,” he said. “This allows a much simpler option that anyone can do, which will hurt a lot less for those who made need to do frequent testing.”