Lee’s Summit Lab That Got FDA Warning Letter Over Its COVID-19 Test Says It Complies With The Law
CoreMedica Laboratories was one of several diagnostic companies that received warnings from the FDA in July stating it offered unauthorized COVID-19 testing services.
A Lee’s Summit blood testing company that received a warning letter from the Food and Drug Administration about its at-home COVID-19 antibody test says it is fully compliant with the law.
CoreMedica Laboratories received the warning in July stating it was offering unauthorized COVID-19 testing services.
The letter directed the company to take action within 48 hours. But CoreMedica’s website continues to advertise its antibody test.
Cory Zuehlsdorf, the founder and CEO of the company, acknowledged that when the FDA conducted its review of CoreMedica’s website in June, “we had some inconsistencies with the way we were doing self-collection.”
“But since that time they have also granted self-collection on the PCR test to a few companies, and now we’re working with them on the serology side to get our self-collection process approved as well,” he said.
PCR tests are used to detect a virus’ genetic material. Those are different from serology tests like CoreMedica’s, which detect the presence of antibodies generated by the body’s immune response to a viral infection.
Although CoreMedica has removed the language over which the FDA issued its warning, it is still offering a COVID-19 antibody screening test using a fingerstick.
Zuehlsdorf said the test is a modified version of one developed by drug company Roche, which has received so-called emergency use authorization for the test. CoreMedica collects dried blood and then turns it back into wet blood, which is then run through the test, Zuehlsdorf said.
For that reason, he said, the FDA doesn’t even have jurisdiction over labs like CoreMedica, which do laboratory developed tests, or LDTs, that are designed, manufactured and used within a single laboratory. The FDA says it generally doesn’t enforce pre-market review and other FDA requirements for LDTs because they’re relatively simple lab tests and generally available on a limited basis.
But that exception doesn’t apply to home collection or direct-to-consumer tests, which do require FDA review before they’re marketed.
Zuehlsdorf insisted that CoreMedica does not offer direct-to-consumer tests. Instead, he said, it offers a direct-to-consumer blood collection method for laboratory tests run solely at its lab. And the blood collection method has been approved by the FDA.
Zuehlsdorf also pointed to recent guidance by the Department of Health and Human Services stating that labs developing LDTs do not need pre-market review by the FDA. But that guidance also specifically says that direct-to-consumer tests are not considered LDTs.
“Any DTC (direct-to-consumer) test, including tests shipped by commercial labs, are still required to go through pre-market review at FDA, as they are clearly medical devices under applicable statutes,” the department says in its FAQ section on laboratory developed tests.
While Zuehlsdorf said CoreMedica immediately responded to the FDA’s warning letter, the agency does not appear to agree – at least not yet – that the company is in compliance.
On the FDA’s listing of firms that have received warning letters, the agency places an asterisk in a column called “Corrective Status” to indicate that a firm has come into compliance. No asterisk, however, appears for CoreMedica.
James McKinney, a spokesman for the FDA, confirmed in an email that “the asterisk does not appear beside their name on the website.” He was unable to provide further information on CoreMedica's status.
Zuehlsdorf said the FDA was mistaken in its assessment.
"The FDA does not know us from Adam and had no idea of exactly what we were doing or offering until I responded with the information in my response to them," he said in a follow-up email to KCUR. "I will bet they still haven't reviewed it. "
Zuehlsdorf said he could not share his response to the FDA "as it gives away some unshared details and some of our IP."
Zuehlsdorf founded CoreMedica in 2010. Before the COVID-19 pandemic, most of its business came from screenings it conducted for corporate wellness programs. But the pandemic caused that business to dry up, Zuehlsdorf said, leading him to offer serology testing as a way to keep the lab open.
“So you can imagine that I had 263 screening events lined up between February and the end of May, and practically overnight they all went away with COVID,” he said.
CoreMedica markets its blood sample collection kit for COVID-19 on its own website and through a website called TestMyDrop. According to both websites, users can finger-stick themselves and send the resulting samples to CoreMedica for serology testing.
In May, CoreMedica sent out a press release touting its test, saying it could be completed anywhere, “reducing the need to travel to a doctor’s office or testing site.” The company said it was collaborating with the COVID-19 task force in Cass County and the Cass Community Health Foundation.
Dr. Kevin Latinis, a scientific advisor for the task force who is quoted in the release, said the technology has been available for decades “where you prick your finger and there’s blood that goes on these little pieces of paper. It dries out, you can mail it through the mail and then it gets rehydrated at the lab and run just like a regular blood drop.”
“Technically what happened was CoreMedica put out a marketing release and published it on their website – that they were using their home testing kit, which they use for corporate wellness, cholesterol and blood sugars and all that – for COVID, and that wasn't legitimate with the FDA,” Latinis said.
Latinis, a rheumatologist with a Ph.D. in immunology, has since joined CoreMedica as its chief medical director.
Latinis said CoreMedica's test was especially useful at a nursing home in Harrisonville, Missouri, that had experienced a lot of deaths.
“I work in Harrisonville and one of the things we did was use the kit to go in there and screen a lot of their employees and residents,” he said. “And we were able to find a couple of silent carriers and get them out of there until they were better.”
CoreMedica is not the only Kansas City area company that has received warning letters from the FDA or from the Federal Trade Commission about marketing unauthorized COVID-19 tests or treatments.
Other area companies that have received such letters in recent months and the tests or treatments they offered include:
· Epigenetics Healing Center in Overland Park, Kansas, which promoted vitamin and glutathione IV treatments.
· McDonagh Medical Center in Gladstone, Missouri, which promoted high-dose vitamin C, ozone therapy, ultraviolet blood therapy, hyperbaric oxygen therapy and other treatments and products.
· Revive & Rally Health Lounge in downtown Kansas City, Missouri, which promoted vitamin C treatment.
· Cathay Natural in downtown Kansas City, Missouri, which promoted herbal products and traditional Chinese medicine treatments.
A review of those companies’ websites appears to show they have stopped offering the products in question.
And though not based in the Kansas City area, televangelist Jim Bakker, whose Jim Bakker Show originates in Blue Eye, Missouri, was also the recipient of an FDA warning letter in March. The letter called Bakker to task for promoting something called “Silver Sol Liquid” or “Silver Solution” to prevent, treat, or cure COVID-19.
A few days later, Missouri Attorney General Eric Schmitt sued Bakker and his production company to stop them from advertising or selling the products as treatments for the coronavirus. The case is pending in Stone County, Missouri.