Saturday, November 26, 2022

FDA: W&M COVID-19 testing provider has no emergency use authorization

Residents and family members wore masks and followed physical distancing protocols when moving into residence halls Aug. 12-14. (WYDaily/Courtesy of W&M News, Jim Agnew)
Residents and family members wore masks and followed physical distancing protocols when moving into residence halls Aug. 12-14. (WYDaily/Courtesy of W&M News, Jim Agnew)

As more and more universities in the nation that have opened for in-person classes continue to see a surge in positive coronavirus cases, William & Mary seems to be poised to proceed with its own classes as planned.

The university decided to test all its students for the coronavirus before arriving on campus for the fall semester but it appears it used a provider whose coronavirus tests were not approved by the U.S. Food and Drug Administration.

University officials have opted to send at-home testing kits to students, operating an honor system, leaving students to test themselves and send the samples to a laboratory for processing with results available before they set foot on campus.

FDA spokesman James McKinney wrote in an email neither Kallaco, the third party provider who partnered with the college and VCU Health for the COVID-19 test kits, or Opteo Laboratory, the testing lab Kallaco used to process the tests had not received FDA’s emergency use authorization.

“Those two companies do not have EUAs currently,” he said, referring WYDaily to a section of the FDA’s FAQs on Testing for SARS-CoV-2 webpage.

The following screenshot from the FDA’s website shows Opteo Laboratory LLC had notified the FDA “they have validated their own COVID-19 diagnostic test” and per CLIA, the laboratory has met the requirements to “perform high complexity tests.”

The laboratory’s current authorization status is “Not FDA Authorized.”

This section of the FDA’s website notes the department does not object using validated tests while the laboratory is preparing an EUA request and believes 15 business days is a “reasonable period of time” to submit an EUA request.

Certain developers have completed the EUA process before offering clinical testing instead of notifying the FDA under the CLIA policy.

“If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be addressed in a timely manner, the FDA intends to remove the laboratory from this list and may take additional actions as appropriate,” according to the FDA’s website. “Note that many other laboratories, including public health, commercial, and healthcare system/academic laboratories, around the country are providing testing for COVID-19 using an EUA authorized test.”

While the FDA noted the nasal or throat swab tests used to detect COVID-19 are “highly accurate,” the department noted the ThermoFisher systems could give false positives.

Opteo Laboratory’s website states the company processes the throat swab samples using ThermoFisher Quant Studio 12K Flex Real Time PCR System for the SARS-CoV-2 assay.

Not only did W&M use the Kallaco tests, VCU did, too.

The VCU and GMU chapters of the American Association of University Professors questioned just how reliable the test were and on Aug. 21, AUUPMason said in a Facebook post that tests sent to its students in July and August were not approved for self-administration by the FDA’s EUA program, which “radically undermines” their confidence for a safe return to campus, according to the Capitol News Service.

Opteo Laboratory did not immediately respond for comment.

W&M response

The university posted a statement on its COVID-19 Testing page, about its partnership with Kallaco in response to the scrutiny.

“Our testing partner, Kallaco Health & Technology, confirms that their labs are CLIA approved and the test kits provided to our students have been approved by the FDA for home collection,” according to the news release which linked to Kallaco’s statement about the COVID-19 tests. “We remain in constant contact with the company CEO and Kallaco is committed to providing concrete answers to any concern raised.”

Both the university and VCU Health decided to pick Kallaco as the COVID-19 testing provider through the “state’s procurement bid process” and even though Kallaco was recently created, the founders “have a long history in software development and the healthcare space,” which was vetted by W&M’s chief information security officer, according to the university’s statement.

W&M spokeswoman Erin Zagursky wrote in an email Aug. 18 that fewer than 10 college students and employees have tested positive for the virus before coming to campus but she did not share the exact number of positive cases, citing privacy issues.

The William & Mary’s Regional COVID-19 Testing Results dashboard, which is updated daily, as of Tuesday showed the university had tested 4,422 students and 604 employees.

The dashboard shows 13 students tested positive before coming to campus. Fewer than 10 employees have tested positive for the virus.

It remains unclear whether the employees tested positive prior to setting foot on campus.

“Positive test remain below the reporting threshold required to protect the privacy of individuals,” according to the university’s COVID-19 dashboard. “Positivity rates for W&M are lower overall than rates for the region. Individuals in the W&M community that test positive are included in regional and City numbers.”

So why didn’t William & Mary have its students, faculty and staff get tested for COVID-19 at a doctor’s office instead of the self-swab test kits?

Suzanne Clavet, another spokeswoman for W&M, wrote in an previous email to WYDaily the university chose to have the students tests themselves at home to have more consistent testing data and let students who are positive but asymptomatic know they have the virus.

“This centralized testing approach allows the university to contribute to the public health data analysis that is helping to drive Virginia’s, as well as the university’s, responses to the pandemic,” she wrote on Aug. 5. “Using a centralized vendor allowed the university to pay for the testing.”

WYDaily reached out to Clavet on Monday to confirm the university used Kallaco for the COVID-19 student testing and if the testing provider was cheaper or more expensive than using private labs such as LabCorp or Quest Diagnostics.

She responded via email, saying the university thought the “best course of action” was to test all the students before they returned to campus in the fall and one of the many reasons the college chose Kallaco was due to the company’s “robust network of national labs.”

“Having central collection and reporting of test results allows the university to monitor positivity rates on campus and share the data, as seen on the university’s COVID-19 Dashboard, with the community,” she wrote.

Clavet did not answer whether using the Kallaco tests were cheaper or more expensive than LabCorp or Quest Diagnostics.

Kallaco’s response

“Kallaco is proud to be a trusted partner delivering the highest-quality COVID-19 testing available in the United States,” according to the company’s statement. “Our company, which marries the latest in technology and testing, was created by U.S. healthcare executives who have worked for decades supporting universities, hospitals and employers in many different capacities, all driven by the intention to provide a much-needed, modern service when communities need it most.”

The company partnered with three CLIA certified labs, including Opteo Laboratory, to give test results in 36 to 48 hours and to date has tested more than 20,000 people.

“Much of the Virginia university testing to date has been in concert with Kallaco’s partners at Opeto Labs, which is a high complexity CLIA laboratory,” the company noted.

The company added the average testing turnaround time is 44 hours and they plan to post more information on their website in an effort to be as “transparent as possible.”

“The testing provided by Kallaco has all of the licenses required in the U.S,” according to Kallaco’s statement. “Our testing has been submitted to the FDA through the Emergency Use Authorization (EUA) process and our labs have the authority to run this test under current FDA EUA guidelines.”

HealthEco LLC

WYDaily reached out to HealthEco LLC, a Chicago-based health care firm also run by ex hospital executives who had partnered with Kallaco recently, to see the extent of their partnership, if they had tested the COVID-19 tests and why they decided to partner with the company.

HealthEco managing partner Kyle Hathaway referred WYDaily to Amy Cheronis, who was tasked with “handling all news inquiries,” for comment.

Cheronis told WYDaily in an email HealthEco is a “consultancy” which works with health care startups and health systems, including Kallaco.

“Kallaco’s mission to create connected communities of care resonated with HealthEco’s overall mission to bring together the healthcare ecosystem to better improve health outcomes,” Cheronis wrote in an email. “Their leadership team is well known in the healthcare community and their reputation for creating valuable solutions within healthcare is impeccable.”

She confirmed Opteo Labs processed the W&M COVID-19 test kits, adding the collection kits had been “internally validated” and sent to the FDA “under EAU guidelines.”

“The tests are analyzed by qualified medical professionals in labs that comply with Clinical Laboratory Improvement Amendments, CLIA, regulations,” she added. “Kallaco continues to work with the FDA as new guidance and requirements evolve for testing.”

Cheronis said Kallaco’s testing through their laboratory partners all have licenses required in the U.S.

“As an extra step, the testing methodology has been submitted to the FDA and that Kallaco laboratory partners have the authority to run the tests under FDA Emergency Use Authorization (EUA) guidelines,” she wrote.

As of Tuesday, Virginia has 114,635 positive cases, 9,259 hospitalizations and 2,494 deaths, according to the Virginia Department of Health website.

The latest coronavirus cases, hospitalizations and deaths in the Historic Triangle from the Virginia Department of Health. (WYDaily/ Julia Marsigliano)
The latest coronavirus cases, hospitalizations and deaths in the Historic Triangle from the Virginia Department of Health. (WYDaily/ Julia Marsigliano)

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Julia Marsigliano
Julia Marsiglianohttp://wydaily.com
Julia Marsigliano is a multimedia reporter for WYDaily. She covers everything on the Peninsula from local government and law enforcement agencies to family-run businesses and weather updates. Before WYDaily, she covered Hampton and Newport News for WYDaily’s sister publication, HNNDaily before both publications merged in December 2018. Julia was born in Tokyo, Japan and moved to Long Island, New York in 2001. A true New Yorker, she loves pizza, bagels and good Chinese food. Send comments, tips and other tidbits to julia@localvoicemedia.com. You can follow her on Twitter at @jmarsigliano

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