Faculty members are raising concerns about the reliability of the tests being used to screen students at three prominent Virginia universities for COVID-19 before they return to campus.
George Mason, William & Mary and Virginia Commonwealth University all contracted with Kallaco, a newly-formed corporation, to provide at-home testing kits and health tracking software for the thousands of students expected to return to campus. But faculty leaders, who released a letter to university administrators and the Virginia Department of Health on Friday, said the partnership raised red flags from the beginning.
Kallaco was chosen through sole-source procurement, which allowed the schools to purchase services from the company without competitive bidding. In some cases, the company was chosen over established diagnostic labs, including LabCorp and Quest.
But public records show that Kallaco, based in Delaware, was only incorporated in April by a New Orleans-based founder with a background in health care consulting but no laboratory testing experience. A Kallaco spokeswoman said the company processed the majority of Virginia’s student testing through Opteo Laboratory, a genetics testing company also based in New Orleans.
“We are concerned that the companies involved may not have sufficient experience for such an important task,” the letter reads “It seems odd to us that this young IT company, which has been awarded sole source state contracts with a potential value of over $4 million, has been entrusted with the critical COVID-19 testing for up to 28,500 students at our universities.”
More concerning, faculty said, was the lack of information available on the tests sent out to students. Opteo Laboratory has not been authorized by the U.S. Food and Drug Administration as having validated its own COVID-19 diagnostic test, according to one of the agency’s online databases. It currently advertises PCR (short for polymerase chain reaction) testing through a diagnostic system — and assay — developed by the life sciences company Thermo Fisher.
Kallaco spokeswoman Amy Cheronis said that the company’s current partners have all chosen PCR testing through Opteo. “Once we assign a laboratory partner to a client, we then orchestrate the ordering and shipping of kits (specific to that laboratory partner) to our clients for use in their community of users,” she wrote in a Monday email.
VCU could not provide further details on the exact test sent to students, describing it only as “the throat swab PCR test as approved by FDA,” according to a Friday email from spokesman Michael Porter. But Melanie Balog, a spokeswoman for George Mason, confirmed that the university sent out Thermo Fisher’s TaqPath COVID-19 Combo Kit.
That test kit has not been validated for samples self-collected by patients, according to an Aug. 19 email from the FDA in response to a query from a George Mason professor. Two days earlier, the FDA also released a letter warning that the TaqPath Combo Kit also carried a risk of false results “based on two issues related to the test kit” and the associated software.
Faculty at George Mason and VCU said the information raised concerns that residential students were being screened with invalid tests before returning to campus. In online forums, multiple students reported that their test results were listed as “rejected” by Kallaco. One George Mason student shared a photo of a sample tube stamped with “For Research Use Only — Not For Use in Diagnostic Procedures.”
To date, Opteo — a lab that’s now tested thousands of students for COVID-19 — has not submitted any of its results to the Virginia Department of Health, agency spokeswoman Tammie Smith confirmed in an email on Friday. Private labs are required by state and federal regulations to report positive coronavirus test results to state health departments.
“We plan to reach out to them,” Smith wrote. “We also plan to reach out to the universities and colleges to ask them to help us identify any private labs conducting testing for them so we can work together on ensuring the lab reports are sent to VDH.”
The combined value of the contracts between Kallaco and all three universities is more than $1 million. Procurement documents show that all three schools chose Kallaco over established testing services, including LabCorp and Quest, at least partially due to concerns around testing volume and turnaround times as they prepared to reopen their campuses to residential students.
“LabCorp is the only other testing service that we looked at and they were unable to meet our need for the athletes in May,” Thomas Briggs, VCU’s assistant vice president of safety and risk management, wrote in a July 15 procurement request. A July 25 request signed by Ed Aractingi, William & Mary’s chief information officer, states that “Kallaco has confirmed its ability to meet W&M’s need for an estimated 9,000 test kits prior to the start of the fall semester.”
“Given circumstances related to pandemic, single source for the testing option — especially with limited availability of kits in market,” reads a note at the bottom of the document. Price was also a factor. George Mason’s procurement request mentions that Kallaco was “between an estimated $200,000 and $300,000 less expensive than One Medical,” an established health services company.
But even with Kallaco promising fast turnaround times, students and faculty at multiple universities said that testing quickly became mired in delays. Elias Nafziger, a junior at William & Mary, said he mailed back his test kit on Aug. 6 but didn’t receive results until Aug. 11 — the day he was originally scheduled to move back to campus.
George Mason had to address technical issues and delayed test deliveries in a July 30 Facebook post. Emails obtained by the Mercury show the delays forced the university to extend its original deadline for test results from Aug. 5 to Aug. 10. Even then, some students were expected to arrive on campus without receiving results.
“For students who need to stay on campus while results are pending, Mason Housing Staff will be able to provide options during the move-in process,” reads an Aug. 10 university email with the subject line “Information for those still waiting on Kallaco test results.”
“Students in this situation — referred to as ‘quiet quarantine’ — will be permitted to utilize campus dining grab & go meal service but will be expected to wear a face mask at all times and otherwise socially distance from others when not in their private bedroom,” the email continues.
Balog said that as of Friday, 10 additional George Mason students were tested for move-in. “Six of those results have come back and they were all negative. Four more students are waiting on their results,” she wrote in an email. A total of five students are quarantining as they wait for test results from Kallaco or another provider, “either at home, in a solo room or in a temporary quarantine space on campus,” Balog added.
She did not provide additional information about whether positive cases have been found on campus. Yesterday, VCU confirmed that 25 students and 11 employees have tested positive for COVID-19 since the campus reopened earlier this week. William & Mary said that confirmed positives are low, but refused to provide an exact number.
“So far, our return-to-campus testing positivity rates are so low (under 10 in the respective categories for students and employees), that providing them would compromise the privacy of those individuals who tested positive and who are not currently on campus,” spokeswoman Suzanne Clavet wrote in an email on Friday.
CLARIFICATION: The faculty leaders who sent a letter to state officials Friday represented GMU and VCU. This post has been updated to clarify that detail.