How one small, high-tech lab adapted when the pandemic changed everything

How bad does it hurt?

It’s a routine question asked by doctors, and the answers help them figure out what’s ailing their patients and how to relieve their suffering.

But while assessing pain can be a key to a medical diagnosis, it's usually remarkably unscientific. Doctors typically ask their patients to rank their pain on a scale of 1 to 10, a totally subjective analysis that is subject to mistakes, misinterpretation, and exaggeration.

Surely there should be a better way to diagnose such a critical part of medical care.

That idea motivated researchers at Ethos Laboratories in 2013 to begin studying the chemistry of pain. Founded in 2010 and now based in Newport, Ethos Laboratories began as a small firm offering urine tests that doctors could use to ensure their patients were taking their medications as prescribed.

Originally based in Fairfield, Ohio, Ethos moved to Newport in 2013, as CEO Brian Kincaid was searching for a more urban location for the company and its workforce.

“We were looking for a place that would allow our employees to get outside, walk around, and feel like they’re part of a community,” Kincaid says.

There were plenty of suburban office park locations to look at, he said, but “we wanted to create an environment for our employees that felt like a nice place to go,” he says. “Newport has character.”

It found a vacant, 30,000 square foot former Trauth Dairy facility that it renovated into laboratory and diagnostic space, and joined a growing life sciences environment in Northern Kentucky that includes Wood Hudson Cancer Research Labs in Newport, Bexion Pharmaceuticals in Covington, PPD Laboratories in Campbell County, and ViaCord in Boone County.

And as the Covid-19 pandemic swept the region and the country, Ethos researchers developed tests for the viral infection to help schools, nursng homes, and other facilities to keep operating, and is now offering a test that can show how well the Covid vaccines work.
  
Before the new virus changed the business and medical landscape, Ethos leaders had developed relationships with physicians across the country, some of whom wanted better, more accurate methods for assessing pain. “They didn’t have reliable tests,” Kincaid says.

Researchers at the startup spent four years analyzing what makes pain hurt and in 2017 introduced a test that identified “biomarkers” of pain, measurable changes in the body’s chemistry that could help doctors find the right treatment, possibly without using opioids, or at least without using so much.

“Pain is very complex,” Kincaid says. “There’s not a lot of objective measurements that can be used. We focused on biochemistry as a factor in someone’s pain.”

Ethos researchers analyzed the data of more than 17,000 patients and found that 77 percent of them had at least one measurable abnormality in their biochemistry, such as chronic inflammation or nerve damage.

“There was very little focus or attention paid to biochemistry,” Kincaid says. “That’s what we’ve done.”

"We created a scale that generates a score of 0 to 100, indicating the likelihood that biochemistry is playing a role in pain,” Kincaid says.

The test uses a urine sample that is processed at the Ethos facility, with the results reported back to the doctors the next day, Kincaid says.

“The goal is to add an element for a physician to consider with their chronic pain patients,” Kincaid says. “This gives them the opportunity to have a new conversation with the pain patient. This may be the first time they found that they can treat it without opiates or needles.”

With the test available in 38 states, things were going fine until about a year ago, when the pandemic changed everything. People stopped going to see their doctors.

In short order, Ethos adapted to the new reality. It built a new lab devoted to the new national emergency – detecting the Covid-19 virus. Ethos became the first lab to receive the FDA’s emergency use authorization for a test using a new technology called matrix-assisted laser desorption ionization–time of flight mass spectrometry. In layman’s terms, that means the test is a bit more complex and labor intensive than other Covid tests, using a three-step process, and looking at five biomarkers for the virus instead of just one or two.

That complexity resulted in fewer false positives or false negatives, issues that had plagued Covid testing from the beginning.

“Having a false negative gives somebody a sense of not having the virus and being noncontagious, and then going out in public,” Kincaid says. “Having those five markers gave us higher confidence in the results.”

Ethos has been working with school districts to offer ongoing testing, universities on return-to-campus testing and long-term care facilities, Kincaid says.

Ethos has grown from 140 employees before Covid to about 225, with about 90 based in Newport, Kincaid says.

Then late last year, Ethos began offering a test to determine how immune one is from being infected with the virus. While the vaccines currently on the market prevent people from getting sick from the virus or showing symptoms, they don’t necessarily prevent infection.

The test is called Tru-Immune and it may help government officials, medical experts and other determine the levels of immunity in the population and when a return to post-Covid “normalcy” might be possible.

“Tru-Immune is the first test to evaluate protective immunity to the SARS-CoV-2 virus that does not require the use of live virus, cell culture or even pseudovirus,” says Joshua Gunn, chief science officer of Ethos.

“This is a test that can indicate whether the vaccination produced the neutralizing antibodies,” Kincaid says. “From a peace-of-mind standpoint, this test can tell if the vaccine that I just got worked and did it do what it was supposed to do?”

And peace of mind is a worthy goal anytime, especially in the Covid era.

 

 

Read more articles by David Holthaus.

David Holthaus is the managing editor of NKY Thrives, an award-winning journalist, and a Cincinnati native. When not writing or editing, he's likely to be bicycling, hiking, reading or watching classic movies.
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