This tiny Texas company is running most of the drive-thru Covid-19 testing in the U.S.

On March 13, President Trump stood next to the CEOs of LabCorp, Quest Diagnostics, Walgreens, and Walmart in the Rose Garden, declared a national emergency, and promised the government would work with pharmacies and retailers to create drive-thru testing sites to help get the coronavirus pandemic under control.

Four months later, more than 700 federally backed drive-thru sites are collecting thousands of tests per day. The government has spent nearly $230 million to pay for the tests run at those sites, which it calls Community-Based Testing Sites.

But it’s not LabCorp or Quest running the majority of those sites — instead, it’s a tiny Texas company whose CEO was not in the Rose Garden that day.

That company, eTrueNorth, doesn’t run Covid-19 tests, ship them to and from labs, or employ the staff at testing sites. Instead, the company is acting as a kind of conductor, helping to oversee a patchwork of clinical laboratories, pharmacy staff, and technical infrastructure. The company has brought in more than $90 million in federal contracts to help oversee more than 350 sites and pay for the tests, according to a federal contracts database.

Interviews with public health officials, retailers and independent labs that have dealt with eTrueNorth paint the company’s work as a functional, flexible piece of a testing infrastructure that has otherwise been plagued with problems. They say that the company has listened to their partners and created a network of independent labs that can deliver results relatively quickly.

“We couldn’t have pulled it off without a partnership with eTrueNorth. They were answering their phones Sunday night at seven o’clock,” said Nancy Lyons, the chief pharmacist for McKesson’s Health Mart, which hosted some eTrueNorth-run sites. It’s been “a really great partnership … with them — even in the midst of things that didn’t always go perfectly the first time.”

However, eTrueNorth’s contribution to the U.S. testing effort has been relatively small. Its labs have run far fewer tests than larger commercial labs — and experts warn the federal government’s broader approach to testing still leaves much to be desired.

“I think that these [drive-thru] testing sites are actually a net good, in general. What I don’t know, though, is … was the bang worth the buck?” said Geoffrey Baird, the interim chair of laboratory medicine at the University of Washington who has not worked with eTrueNorth. “That’s something that six months from now, we need to look back and say, ‘Well, in the places where these things were implemented, were there slower spreads?’”

In 2013, Coral May decided to begin yet another company. A serial entrepreneur and a registered nurse, May incorporated eTrueNorth as E3Health Solutions in Mansfield, Texas, with Michael McEntee. May is the CEO of that company; McEntee is the chairman.

eTrueNorth is among a string of health-related organizations May has founded and folded in the past two decades, including Predictive Strategies, E3 Communications, and the American Association of Mid-Life Women, according to public records.

What May and McEntee’s new company offered its earliest clients was expertise. May had worked for Humana in the late 1990s; McEntee was a licensed clinical laboratory specialist. Together, they knew how to bring a pharmacy up to scratch with the various state and federal laboratory regulations and how to develop an electronic records system that could connect pharmacies’ computer systems to insurance records and report results to multiple people and places while respecting medical privacy laws.

In the fall of 2016, Walmart became one of the company’s clients. The retailer wanted to get some pharmacies ready to do some basic clinical tests like flu screenings. eTrueNorth has also handled Walmart’s employee wellness days and screenings.

Those kinds of employee wellness programs were the bread and butter of eTrueNorth’s business before the pandemic. Keeping people up to date on their basic care appealed to both employers and insurance companies, which hoped regular care would keep their costs low. And being able to perform some basic tests was a potential source of new revenue for pharmacies.

“People are creatures of habit,” said May. “Patients may see their [primary care] provider, once or twice, maybe four times a year — but they’re in the pharmacy, on average twice a month.”

So when Walmart was asked to help build a Covid-19 testing strategy, it turned to Quest and eTrueNorth — two testing partners it had worked with before.

But Walmart’s pharmacy-based labs — and most of the other labs that eTrueNorth helped establish — don’t have the requisite certification to run high-complexity tests like most of the early Covid-19 tests.

Labs in the United States are governed by a set of standards called the Clinical Laboratory Improvement Amendments, or CLIA. Laboratories that want to run very simple tests can apply for waivers from these regulations. But some tests require professionals to run a more involved protocol or use more complex equipment.

For eTrueNorth to sign a contract with the Department of Health and Human Services, it needed to find CLIA-certified labs that would run whatever tests they collected. Eventually, it found three: HealthQuest Esoterics in California, Gravity Diagnostics in Kentucky, and Reditus Laboratories near Peoria, Ill.

Before the coronavirus, a good chunk of Reditus’ clientele was podiatrists. But the lab had a certification from regulators to run high-complexity tests — like some Covid-19 diagnostic tests. And it had the machines that could run ThermoFisher’s TaqPath Covid-19 test — one of the first diagnostic tests the FDA authorized.

Reditus can process about 6,500 to 7,000 tests a day, though not all of those come from the Community-Based Testing Sites program. (The lab also processes tests run for a local meatpacking plant and at sites that the state of Illinois operates.)

“We basically went from being a toenail lab to being a Covid lab within a matter of two weeks,” said Molly Rossi, Reditus’ clinical laboratory manager. (Molly Rossi is married to the lab’s CEO, Aaron Rossi.) “It was such a fast turnaround.”

Both Aaron and Molly Rossi said the partnership with eTrueNorth has run relatively smoothly, though they admit they are grading on a curve. “No one had experience with this — this has never existed. So there’s definitely growing pains,” said Aaron Rossi.

They particularly valued the company’s flexibility, Molly Rossi said.

“We could say ‘Hey, this isn’t working super well, like what would you think if we did this instead?’” she said. “That’s not always the case at some of these sites.”

eTrueNorth’s willingness to pivot has been especially helpful in Louisiana, according to Kim Hood, a community-based testing sites director for the Louisiana Department of Health. She has been working with the company since early July, when HHS tasked eTrueNorth and others with setting up several high-capacity temporary “surge testing” sites there and in Texas and Florida.

Hood and her team asked for multiple, mobile units, rather than the single testing site that HHS had originally authorized; they also wanted to open the sites earlier and keep them running later than HHS’s original plan.

And perhaps most crucially, she said, they department wanted to make on-site registration happen. Hood says it was no small ask; pre-registrations are intended to prevent hours-long lines of cars seen at some testing sites. But at some surge sites, eTrueNorth’s system was adapted to make on-site registration possible.

Working with eTrueNorth “has been as positive [an experience] as testing outside in 105 degrees can possibly be,” she told STAT.

So far, eTrueNorth’s labs have avoided some of the turnaround delays that have plagued larger labs like Quest, which is now saying that some test results might not be available for one or two weeks. According to Hood and Walmart, results of the tests collected at eTrueNorth’s sites have come back within three to five days.

However, the federal government’s community-based testing sites account for a remarkably small proportion of the country’s daily count. By July 24, about 1.1 million people had been tested over three months through the CBTS program, according to recent congressional testimony; an eTrueNorth spokesperson characterized the CBTS program as “an integral component of the nation’s testing landscape.”

According to the CDC, labs across the country have reported results from more than 52,000,000 tests.

The HHS funding for the CBTS program — which appears to total about $230 million, according to contracts — also pales in comparison to the more than $10 billion the agency has given state and local authorities for their testing efforts.

“I think we have done a great job at making testing available. Is there work to be done? Sure. I think there’s always work to be done,” said May, the CEO of eTrueNorth. “There is testing available. And there are also supply chain constraints.”