With the discomfort and sometimes pain that come along with nasal swabs, the demand for a less stressful coronavirus testing solution has been high. Thus, a local Marshall company, “mLife Diagnostics LLC”, has answered the call, inventing an oral COVID-19 test kit that’s designed to not only be more manageable, but also more safe.
“We hope eventually it would be available for at-home, but initially it’s available through doctors in our lab,” said Alan R. Loudermilk, CEO of mLife Diagnostics. “But it’s designed to be easy to use — so easy that we do not have to have healthcare professionals such as doctors or nurses to administer it.”
Loudermilk said he was initially working on a drug testing product called “mLife Verified” when the need for a coronavirus testing kit came his way instead.
“About two-and-half years ago, we got involved in a medical startup and were making a drug test where we took a prototype and created this product called the mLife Verified,” he said, noting it’s a drug test that calls for the instant detection of drugs through an oral swab process that’s sent to a laboratory.
“We launched it early March of this year, and then the coronavirus hit,” said Loudermilk. “So, the customer said we’re not interested in drug tests anymore.”
More interested in responding to the global COVID-19 pandemic, Loudermilk then came up with the idea of his new invention, the “mLife DX True” oral fluid/viral collection kit.
“I came up with this idea about six weeks ago,” the inventor and local business owner said. “In 30 days we went from concept to production.
“We came up with the idea sitting right here,” he said of his 511 N. Washington Ave. location, “and then 30 days later, we were in production.”
Loudermilk said the concept is similar to his drug testing kit, which is the collection of oral specimen to be tested. The concept is also to optimize the workflow for COVID-19.
“We’re in production,” said Loudermilk. “It’s available if a doctor prescribes it through the lab. We’re not available for at-home yet, because that requires that extra FDA approval.”
“But we have two, what is called CAP CLIA labs that are certified, that have validated the use of our instrument to detect the coronavirus,” said Loudermilk.
Being CLIA (Clinical Laboratory Improvement Amendments) certified and CAP (College of American Pathologists) accredited guarantee that test results are meeting industry standards for clinical laboratory testing.
“So under their rules if a doctor says run the specimen and test it at the labs, those labs will run the result,” said Loudermilk.
HOW IT WORKS
The test depends on an oral swab that has to be thoroughly saturated with saliva. A solid red rectangle indicator bar on the swab will indicate that the swab is thoroughly saturated.
The kit then instructs 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.
“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,” the CEO 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.
“You put a label on the vial, put it in triple bags for safety, but the moment you drop it in this buffer, within 30 seconds to one minute, all of the virus is killed,” explained Loudermilk. “It’s deactivated. So the specimen itself, it kills the virus, it kills the bacteria, so this is now a safe sample.”
Another important thing, he said, is that the sample can withstand weeks of ambient, warm temperature.
“We ship this to the lab, so this specimen needs to stay stable for a period of time, so you can ship it to the lab; and so we have data on the buffer that shows that this will stay stable for several weeks,” said Loudermilk. “It can be sent to the lab, the lab receives it and does the test and they post your results either via a secure portal or a secure email link that complies with HIPAA (Health Insurance Portability and Accountability Act).
Loudermilk said test results have been proven to return in less than 24 hours.
“We had a usability test on (last) Friday. The participants in that study took the test at 4 p.m.; and within less than 24 hours later they had their results,” he said.
REASON FOR DEMAND
Loudermilk said he believes the demand for an oral swab is high because of the presumed comfort and safety it presents compared to a nasal swab.
“Nasal swabs are very painful, and they require a medical professional to administer it,” he said. “Actually, administering it particularly to people that are symptomatic, even if they’re not, you may get a cough or they may breathe on you. You’ve gotta be right up (on the patient).
“There’s no social distancing in administering the nasal swab,” Loudermilk continued. “The healthcare worker has to put on this expensive PPE (personal protective equipment), (and) they’re still exposed.”
In addition to being safer, oral swabs are also considered just as accurate, he said.
“We think that saliva has been proven to be just as accurate or more accurate and it can be administered and put no one at risk,” said Loudermilk. “So this can be self-administered or can be under supervision of a doctor.”
A great thing is it still allows for social distancing, he noted.
“I can be a doctor, my patient can be 10-feet away and guide them,” Loudermilk explained. Thus, “there’s no need to put our healthcare workers at risk for a nasal swab, when this is just as accurate.”
The kit comes along with an instructional video and instructions for users.
“And the virus is deactivated, so it’s safer handling on the shipment there,” said Loudermilk.
“So our view is simple — Saliva is better, it’s just as accurate and no one gets put at risk to take the sample,” said Loudermilk. “And I can do it in a doctor’s office or I can do it in a work setting or down; or down the road if the FDA approves it, I can do it at home. So that’s what we would like to see happen.”
News of the Marshall-made invention has already drawn the attention of interested parties across the world.
“We’ve been contacted in the Middle East, South America, (and) Asia about this product already, so the word has spread pretty fast,” said Loudermilk, sharing they’ve also visited with the Texas Secretary of State.
“Our hope is that we can get local labs, and local government agencies and companies to work with us to help people get back to work. And let’s get testing,” he said. “If you need to test somebody, let’s not put our healthcare workers at risk. Let’s do this instead of a nasal swab.”
The next hurdle mLife Diagnostics has to reach now is proving to the FDA that the oral tests are just as good as or better than the nasal ones.
“That’s what the FDA wants us to prove,” said Loudermilk. Thus, “we have to find 60 willing participants who will do the nasal swab — 30 positive (COVID-19 people), 30 negative — and then we will also do our oral swab with them (and compare the accuracy).”
The inventor said they are proud to have designed their oral product in the USA.
“US sourcing is important because we can control it. We do it here. We’re not waiting for something to come in from some faraway place. We control our own production here in the United States — — Marshall invented and US made.”