With school now in session and the threat of COVID-19 and its Delta variant rising, mLife Diagnostics LLC, of Marshall, is making itself available to offer its own non-invasive COVID-19 testing kit to aid schools.

“It’s a weird environment, the schools need to reopen and if you need testing, how do you do it?” said Adam Loudermilk, CEO of the company.

With the virus leaving even local schools in a pickle — some like Waskom having to temporarily close down as a proactive measure to stop the spread of COVID-19 and Wiley College having to temporarily implement a campus-wide quarantine, Loudermilk said mLife is ready to help where needed.

“mLife is ready to assist schools, companies, governmental agencies and other groups with their COVID and drug testing needs,” said Loudermilk.

mLife Diagnostics first launched its initial oral fluid testing product, the mLife Verify drug testing kit, in March 2020, but changed its focus when the need for a coronavirus testing kit came their way instead. Because of the emergence of the global COVID-19 pandemic, at the time, mLife switched its product development efforts from drug testing and optimized it to disease testing.

“In a little over a month, mLife launched a completely new product, the mLife True kit, for detecting infectious diseases such as COVID-19,” shared Loudermilk.

“The mLife True kit received FDA authorization and has been extensively used for COVID-19 testing around the country,” he said, noting its popularity particularly throughout Michigan, South Carolina, California, Ohio, Florida, Washington, and Texas.

“mLife is well positioned now to provide test kits as schools re-open,” Loudermilk said.

Oral vs. nasal

mLife believes the option of an oral solution, for particularly young school children, is preferable because of the comfort and safety it provides compared to a nasal swab.

“As we look into the coming school year, mLife believes that its testing products will find increased use in testing children,” said Loudermilk.

One reason for this is because oral swabs are considered not only more comfortable, but less painful.

“Nasal swabs are generally considered uncomfortable at best, and painful with potential side effects such as bleeding or other complications at worst,” said Loudermilk. “These concerns are amplified in the case of testing children or persons with nasal medical conditions.”

For a child, it could be traumatizing for a long swab to be inserted into the nose, he noted. It could also be upsetting from a parent’s perspective to have the swab inserted into their child’s nose, potentially repetitively.

“If you’re administering that swab to a child, and they all of a sudden are screaming and grimacing, their chance of injury goes up, and guess what, you’re going to pull out,” Loudermilk said of the nasal swab procedure. “Your collection is how much (aggressive) you are, almost, because even if the child doesn’t like it, to get a good specimen you may have to go in and do it longer, do it deeper.”

He noted that the mLife True oral swab kit has been tested on children as young as 2 years old, one of which happened to test positive.

“The oral swab turns red to provide an indication that enough saliva has been collected. It is almost like a game for them. It takes a little time to collect enough saliva, but the collection process is simple and is not invasive and poses minimal risk to the student or the person overseeing the collection.”

The company’s oral product has proven to provide not only a less stressful COVID-19 testing solution, but more accurate results that return within the next day from the lab, he indicated.

“The True products provide a specimen that is sent to a lab typically for what is known as PCR testing, with the results coming next day,” said Loudermilk.

“We are proud to say that we have yet to miss next day results posting with our partner labs and the mLife True kit,” he said.

Loudermilk explained that the mLife True kit provides a polymerase chain reaction (PCR), which is the “gold standard” testing for detecting genetic material in a specimen.

PCR tests

“In the case of COVID, the PCR test detects specific genetic fragments of RNA from the coronavirus. mLife’s initial partner lab, Express Gene of Miami, Florida, analyzes the specimen for three specific gene fragments, the S gene, the N gene and the ORF1ab gene,” he explained. “Analyzing for three separate gene fragments generally makes the test more accurate as effectively it is running three separate tests at the same time, and allows the test to maintain accuracy even with virus mutations such as the Delta variant.

“PCR using three genes is an important consideration for the accuracy of the test and confidence in the posted results,” he added.

Alan Loudermilk credits Dr. Mohammad Faghihi, for his dedicated efforts in COVID-19 PCR testing, and for his hard work in obtaining FDA authorization for the mLife True device and Express Gene.

“When considering a nasal swab versus an oral swab for the younger population or even older students that might need repeat testing (such as athletes), oral swabs with PCR lab testing should be an alternative that is considered,” said Loudermilk.

He noted that although one of the antigen rapid tests that the federal government has provided for free yields results within a matter of minutes, such rapid tests can be inaccurate if their application is not properly understood.

“A lot of people understand only that a test if free — not its real limitations or whatever,” said Loudermilk.

“The US government has given away millions of the Abbott BinaxNOW antigen test kits, so effectively they were ‘free’ — but ‘free’ is only one consideration,” he said. “There should be consideration of the overall experience and outcome for the students, the parents, and the school nursing personnel.

“Moreover, we understand that with ‘home rule,’ school districts have substantial discretion over testing programs with federal grants being available for the cost of the testing program. Cost should not be the issue; what is best for the students and school medical staff should be the prime consideration,” he added. “Start with that nasal swab versus oral swab comparison discussed earlier. Invasiveness, risk of injury, difficulty of collection, etc., the nasal swab has serious shortcomings particularly for younger students. From an accuracy standpoint, you must consider the accuracy of a PCR test versus a rapid antigen test.”

Loudermilk cited a recent study led by the University of Southern California and Los Angeles health authorities in which results from the nasal BinaxNOW antigen test were compared with an oral PCR test.

According to the study, PCR positive children were found positive on the rapid test only 56.2% of the time, which dropped to 51.1% if the students had no symptoms.

“This presents similar odds to flipping a coin,” said Loudermilk. “In other words, you get a rapid result, but in the case of positive children, it is almost a flip of the coin as to whether the rapid test says positive or negative. So you went through the nasal swab experience and if the result is negative you just cannot be that confident in the result.”

“When considering a nasal swab versus an oral swab for the younger population or even older students that might need repeat testing (such as athletes), oral swabs with PCR lab testing should be an alternative that is considered,” said Loudermilk.

With mLife’s product, “there’s no trauma and you get your results next day, but you have confidence in the results,” he said.

While rapid tests can make a valuable contribution, Loudermilk said school officials, parents and students should be made truly aware of their limitations so that they can make the best decisions possible for themselves and their children.

He advised that mLife has kits readily available now for school nurses to use for testing.

“We have plenty of production capacity and units in stock, and lab capacity to immediately start the testing programs in schools,” said Loudermilk. “We would come in and help set up the program for them.”

He said the company also offers training, administrative support services, and has the ability to provide staffing for the testing, if requested. Nevertheless, mLife’s kits are easily trained, said mLife’s Jeanie Davis.

“It’s easy to train someone how to administer our kit,” she said. “It’s not only less traumatizing on the kids, it’s going to be easier for your nurses and administrators because they’re not going to have to fight these kids that are terrified , that maybe already had to have that done and know what it’s like. It’s going to make their lives a lot simpler by using our kit.”

Continued growth

mLife’s also pleased to announce continuing efforts to develop new products, with the latest being the mLife True Plus, the company’s third line of products.

“These products are similar to the mLife True, but one or more test strips are included in the stem of the swab,” explained Loudermilk. “You simply put the swab in the mouth, scrub the inside surfaces of the mouth, and then let the swab absorb saliva. Within a few minutes, you read the result much like you would a thermometer. And, if desired, you can compress the swab and deposit a specimen in a vial that can be sent to the lab for confirmation or other testing.

“We are a believer in having gold standard lab testing available as an option,” he said.

Additionally, mLife is also boosting sales efforts for the Verify product to aid in drug testing. Expounding on the Verify product, Loudermilk said mLife is particularly proud to have the city of Marshall using the company’s Verify kit for pre-employment screening.

“We are grateful to work with the city of Marshall as an early customer as we advance oral fluid testing here and throughout the country and world,” said Loudermilk. “We are saving the city time and money with a better product and service offering.”

Reflecting on the last two years since its launch of its first product, mLife is proud to now have established itself as a leader in oral fluids collection and testing, boasting three quality product lines.

“We started from square one with no experience in dealing with the FDA and the political machinery of government,” said Loudermilk. “We will have many more battles ahead against large, well-funded and politically connected competitors.”

Nevertheless, he said this Marshall and East Texas-based company is ready for the challenge, and looks forward to continuing to provide results that can be counted on throughout the country, and particularly home in East Texas.

“It’s a small town and a small company in a small town that hopes to make noise on a big stage,” said Loudermilk.

“Of course we’d like for everybody around here to be able to benefit from it,” added Davis.

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