Dubious firms offering antibody tests
Companies with little to no experience in testing trying to cash in
“You could see the train wreck coming.”
Scott Becker CEO of the Association of Public Health Laboratories
David Heath, Donovan Slack and Kevin McCoy
Investors accused him in court of deceiving them by driving a Rolls-Royce and wearing a gold Rolex to hide his bankruptcy. The Food and Drug Administration barred him from selling dietary supplements after his company failed a string of inspections.
Yet Paul Edalat’s company, Vivera Pharmaceuticals, is one of more than 150 with the FDA’s blessing to sell coronavirus antibody tests – tests that could become vital gatekeepers to reopening America.
For nine critical weeks during the pandemic, the agency exercised little of its power to decide which companies
“We have a great test, that’s all I can say.
Stephen McColgan Vivera’s chief medical officer
could sell blood tests aimed at detecting whether someone was previously infected. In that vacuum of oversight, USA TODAY — in the most thorough independent review to date — found a nascent industry with inexperienced or dubious companies jockeying to cash in.
For now, public health experts say antibody tests are valuable only for research and identifying plasma donors who could help those who are sick. But if scientists establish that having the virus leads to immunity, the tests could help people decide whether to return to work, socialize or travel. Relying on inaccurate tests poses grave risks.
The FDA’s list of tests has included those from companies with little to no background in medical testing, including one that sells vape pens and one headed by a self-proclaimed technology evangelist. Like Vivera Pharmaceuticals, some have ties to the world of dietary and health supplements; one advertises a male enhancement powder.
At least five companies have claimed that their tests can be used to diagnose COVID-19, a violation of FDA guidelines. Another offers a do-it-yourself option.
Facing withering criticism, the FDA recently tightened its restrictions, requiring companies to submit data on their test’s accuracy and how it will be marketed. In recent days, about 30 tests have been dropped from the FDA list, some of them voluntarily.
The FDA’s new rules spell out a process for evaluating the tests, but not the manufacturers. As a result, even companies led by CEOs with a history of legal entanglements can sell tests.
Responding to USA TODAY’s findings, the FDA said in a written statement that it takes fraud seriously and “continually monitors and conducts surveillance for fraudulent and inappropriately marketed medical products, including tests.”
“We unfortunately have seen unscrupulous actors marketing fraudulent medical products, including drugs and test kits, using the pandemic as an opportunity to take advantage of Americans’ anxiety,” the agency said.
Scott Becker, CEO of the Association of Public Health Laboratories, said lab representatives were on a conference call with the FDA in March. As the agency outlined its initial plans to allow virtually all comers to sell antibody tests, he said, “You could see the train wreck coming.”
‘FDA confidential’
Currently, the only other products Vivera sells are gel pads to relieve scarring. On March 22, the company applied with the FDA for an emergency-use authorization to sell antibody tests. That approval is far less rigorous than the normal FDA review of new medical products, an approach the agency chose to speed up testing in the pandemic.
Vivera’s chief medical officer, Stephen McColgan, told USA TODAY he expects approval soon.
The FDA now requires all companies to reveal the results of validation tests to the agency. Many companies post accuracy numbers on their websites. Vivera does not – and when asked about the test’s accuracy, McColgan was reluctant to answer.
“It’s all FDA confidential,” he said. “We have a great test, that’s all I can say. There’s no reason your readers need to hear this because they don’t have the level of knowledge to understand.”
Later McColgan offered rough estimates of the test’s accuracy, describing it as “very high.”
Vivera’s antibody test is made by a German company Edalat identified as PharmACT. That company has not applied with the FDA. But because Vivera adds small devices to the test box, including lancets to prick fingers, Edalat contended “the FDA looks at us more as the manufacturer.”
The FDA declined to discuss specific companies but said manufacturers should be the ones applying for emergency-use authorization, naming their distributors in their application.
Edalat has a history with the FDA. In 2014, the agency went to court to stop his company, SciLabs Nutraceuticals, from selling dietary supplements, alleging the products had not been tested to ensure they contained only dietary ingredients. At the time, Edalat said: “We would rather work with the FDA than fight them; they play a critical role in consumer safety.”
Just before the Justice Department issued a permanent injunction on behalf of the FDA, SciLabs went under and Edalat declared Chapter 7 bankruptcy. Months later, four investors allege Edalat persuaded them to put $2 million into a company called Pharma Pak Inc., whose products included the controversial hemp product CBD oil.
The investors filed suit, saying they didn’t know Edalat was not allowed to sell supplements.
“Defendant Paul Edalat is a fraud,” the investor lawsuit alleges. It contends he tried to fool investors with his extravagant lifestyle: staying in luxury suites, “wearing a diamond-studded gold Rolex watch which he brags that he purchased for more than $50,000,” and “driving fancy cars, including two Rolls-Royces, three Lamborghinis, a Land Rover, a BMW, a Ferrari, and a Hummer, among others.”
The suit went before a federal jury, which found that Edalat defrauded and libeled some of the investors. He was ordered to pay them $880,000.
In a case awaiting trial, Alternate Health Inc. alleges Edalat told lies to ink a 2017 agreement worth $4.2 million to sell a cannabis supplement. The Canadian company claims Edalat said he could produce the product and didn’t reveal he was barred from doing so.
Edalat is pursuing counterclaims against some of the plaintiffs who sued him in the Pharma Pak case, federal court records show. An appeal in that case also is pending. Edalat similarly filed a counterclaim in the Canadian company case, which court records show is awaiting a scheduled Sept. 29 trial date.
When USA TODAY asked Edalat if the FDA had expressed concern about his history, he said, “No, not at all.” The ongoing agency injunction, he said, involved a different branch of the FDA: Supplements are considered food, while antibody tests are medical products.
‘We see a need’
Experience in medical testing is not a prerequisite to dive into that world today, thanks to the lax FDA rules for antibody tests.
On its website, Jiangsu Eubo Biotechnology Co. offers male enhancement powders, human growth hormones, anti-hair loss powders, steroids and, until the FDA dropped it from the authorized list on May 21, rapid COVID-19 tests. The company’s website features an illustration of barely dressed male and female fitness models. An email sent to the Chinese company bounced back.
In February, another company, Naturitious, sprang up in California. Owner Danny Xu said he had previously manufactured dietary supplements along with test strips to detect ketosis for lowcarb dieters. Producing antibody test kits, he told USA TODAY, is a “pretty similar” process.
Xu said his company has manufactured and shipped 200,000 test kits so far, mostly overseas. The Naturitious website cautions that they are for “professional use only by clinical laboratories and healthcare workers.” It offers an option for customers to buy parts and build their own kits.
Xu said he got into the antibody test business because he wanted to “do something helpful in this pandemic.” But, he said, it’s too complicated for a long-term commitment.
“Working with FDA is hard,” he said. “Dealing with customers is also hard.”
Pacific Connect Group LLC, based in Hong Kong, is run by a physical therapist for the Chinese Olympic Committee. He teamed up with a recent graduate of Rice University who worked briefly for a hardware design company and started a business to automate airport baggage checking.
Company president Jason Wong and Zach Bielak, his vice president of operations, are now selling N95 and surgical masks.
“We are not doctors. We are not medical specialists. We are businessmen. We see a need,” Bielak said.
The duo pledged not to sell their tests unless they get the FDA’s emergency-use authorization.
Not a test to diagnose COVID-19
The FDA requires manufacturers to make it clear that antibody tests should not be used to diagnose active COVID-19, the disease caused by the coronavirus. But at least five companies with antibody tests still on the FDA list say their tests can be used that way. Two corrected their claims after being contacted by USA TODAY last week.
Antibodies don’t show up in the blood immediately when a person is infected. So a test that typically uses a nasal swab to gather mucous is used to diagnose COVID-19.
The FDA says when it becomes aware of fraudulent claims regarding antibody tests, it will “take appropriate action, including criminal or civil action.” The agency requires disclaimers by companies, including, “Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.”
Singapore-based Sensing Self presents its test as a pre-screening tool – a finger-prick blood test individuals can administer themselves before deciding if a lab test is warranted. The site blaresin a pop-up message that the company has the “world’s first COVID-19 Prescreening test,” with results in 10 minutes.
On its product page, Sensing Self also said its test is for diagnostic use, and detecting antibodies “is an effective method for the rapid diagnosis of COVID-19 infection.” It adds: “No lab visits, no doctors Just one finger prick of blood.”
Co-founder and CEO Shripal Gandhi said Sensing Self has sold a “pretty significant quantity across the world” but declined to say how many or where. He said the company has focused on Europe and Asia and now is working with prominent U.S. universities.
Following inquiries from USA TODAY, the company changed the language on its product page.
"We thank you for alerting us,” Gandhi said, “and we have updated the word ‘diagnostics’ to ‘screening.’”