At least three Virginia universities have hired a fledgling New Orleans-based company on no-bid contracts to provide Covid-19 tests to students before allowing them to move into campus dorms, sparking criticism from some faculty members and students.
The company, Kallaco, continues to conduct screening tests designed to keep the virus from spiraling out of control. The College of William & Mary, George Mason University, and Virginia Commonwealth University are among the institutions that contracted with Kallaco — which was incorporated less than four months ago — to handle testing.
Kallaco’s throat-swab test is not approved by the FDA for at-home use.
There’s one problem: The U.S. Food and Drug Administration confirmed to The Chronicle this week that Kallaco’s throat-swab test is not approved for at-home use. That means the FDA has approved the test’s use only when a medical professional collects the samples.
That’s not what’s happening.
Instead, students have been receiving the test kits in the mail and swabbing their own throats. Because of this, the results might be inaccurate. An infected student could receive a false negative, and potentially infect others.
The procedure can be complex for an 18-year-old just starting college. An incoming freshman at William & Mary told The Chronicle that his test instructed him to locate and swab his “bilateral posterior pharynx.”
“Kallaco is an opportunistic company that’s exploiting the pandemic for their gains,” said Bethany Letiecq, an associate professor of human development at George Mason University. “And they’re willing to use ill-gotten procedures and put people’s lives in jeopardy to make a lot of money, off of higher education.”
Letiecq is president of her campus’s chapter of the American Association of University Professors, and she is demanding that George Mason sever ties with Kallaco, retest all affected students using a different company, and investigate how Kallaco was chosen in the first place.
Amy Cheronis, a spokeswoman for Kallaco, responded that the firm “is providing a much-needed solution in these unprecedented times.”
“We stand by the economics of our model and are proud that we have been able to provide testing services through Kallaco that are at, or in many cases, below market rates. The notion that we are ‘exploiting the pandemic for gain’ or that the tests provided through Kallaco are ‘ill-gotten procedures’ is patently untrue.”
Cheronis said that an application has been submitted with the FDA for performing the Covid tests at home, and that the tests are allowed to proceed while FDA review is pending.
Meanwhile, Letiecq and several other faculty members, from both George Mason and Virginia Commonwealth, recently wrote to the Virginia Department of Health, asking it to “investigate this matter immediately.”
The agency declined.
“I don’t think I’ve slept in a week, more than a couple of hours,” Letiecq told The Chronicle. “Because I keep thinking if somebody dies and I don’t do enough to spread the word, how do you live with that?”
$4 Million in Contracts
Kallaco’s no-bid contracts at the three institutions range in value, but collectively, the company stands to be paid more than $4 million for its testing suite of services and related software.
Virginia Commonwealth University selected Kallaco for a no-bid contract on July 15. The university had to fill out a Sole Source Documentation Form to justify paying the company $438,900 without considering any competitors.
Thomas Briggs, assistant vice president for safety and risk management, wrote that another testing company, the better-known LabCorp, had been unable to meet the university’s need to test athletes in May.
And so Briggs recommended Kallaco, which, he said, “offers a service via a web-based app that provides data analysis on testing, testing results, daily health checks and other messaging abilities in collaboration with VCU Health.”
At that point, Kallaco had been in business for less than three months. It had been named Kallaco for just eight days, after nixing the company’s previous name: Strataclear Solutions.
Shortly after the VCU contract was approved, George Mason and William & Mary also hired Kallaco.
Three other Virginia colleges, too, have signed contracts with Kallaco: Randolph-Macon College, Hampden-Sydney College, and Virginia State University.
Hampden-Sydney opted to administer its Kallaco tests differently — having trained staff to test students as they arrived on campus.
Students say the mobile app promised by Kallaco never materialized. It was never available for download in Apple’s app store, they say. And while it appeared in the Google Play store for Android users, it later disappeared from that platform, according to Carter Rainey, a student at George Mason.
“The fact that there’s no approved app … is just something that doesn’t sit right with me,” Rainey said. “I don’t feel that I can trust Kallaco.”
Kallaco said the company “does have a mobile app for clients but has found that a responsive web portal is easier at this time for the universities to customize and incorporate into their system.”
University presidents have acknowledged the growing controversy surrounding Kallaco but are largely standing by the company — for now.
In an email sent Monday night to Letiecq and several other key faculty, President Gregory Washington, of George Mason University, noted that Virginia law does not require colleges to conduct Covid testing before the start of the semester. Washington wrote that some colleges in the state are not doing pre-semester tests at all, and he said George Mason’s tests had identified some students who had the virus. Those students were not allowed on campus until a subsequent negative test result, he wrote.
“This does not ensure that we will catch everyone and that is not the goal,” Washington wrote. “But it does ensure that we will identify some. Look, a student could have taken our pretest and 15 minutes after mailing his/her result could actually contract the virus. We knew the limitations and that is why the home testing was not as big of an issue for us.”
Washington wrote that the university is partnering with multiple providers for Covid testing, because a single company cannot meet the demand. He stressed that “this will not be perfect. We will make mistakes. We are establishing protocols and processes as we speak.”
We acknowledge Kallaco is a new technology company. In fact, most companies in this space are new.
Virginia Commonwealth’s president, Michael Rao, posted a message on the university website Monday that largely parroted Kallaco’s explanation for why there is nothing wrong with the company’s tests.
“We acknowledge Kallaco is a new technology company,” Rao wrote. “In fact, most companies in this space are new. They are being held accountable as is any company doing business with VCU and the VCU Health System.”
“To date, Kallaco has delivered and analyzed 4,401 COVID-19 entry tests for our residential students,” the president wrote. “The results allowed 4,386 students who tested negative (99.7% of those tested) to move into student housing and 15 others who tested positive to seek appropriate care.”
Student Venting
Discussion forums on the social news site Reddit show that students at some of the Virginia institutions were taken aback by the hiring of Kallaco. And after a few perfunctory Google searches, their concerns only grew.
Students noted that Kallaco’s CEO, John Spivey, had started numerous companies in his home state of Louisiana. They voiced concerns that Kallaco’s website was bare, and contacting the company proved difficult.
As testing ramped up, students vented about delays in results, which postponed their ability to move into campus residences. Some students were perplexed by testing vials that were labeled: “For research use only. Not for use in diagnostic procedures.”
And instead of getting positive or negative results, some students said their results came back as “rejected.”
Kallaco said this happens in only 1 percent of cases.
“A specimen is typically rejected if it is compromised or damaged in shipping,” the company said. “In these cases, a new test kit is immediately sent to the student for retesting.”
Letiecq, the George Mason professor, said her disappointment is deepened by the fact that university leaders are stubbornly sticking with Kallaco.
“I think they have boxed themselves into a corner, and I don’t think they know how to get out of it,” the professor said. “But they need to just come clean. They need to just say, We made a mistake, and they need to once again rebuild the public trust.”
Letiecq noted that Covid-19 has ravaged minority communities and that George Mason is a particularly diverse institution: Roughly 45 percent of its students are members of racial or ethnic minority groups.
“We’re an institution talking about racial justice — while we’re doing this?” she asked.
