False advertising: This Seattle Covid test center reveals the 'Wild West' of antibody screening

That a budget hotel has become a makeshift medical facility offering unproven antibody tests highlights the gaps in regulatory oversight at the local, state and federal levels during this pandemic.

Across Seattle, blue yard signs along busy streets advertise walk-in “FDA approved” antibody tests at COVID-19 Test Center.

The location, on 12th Avenue in Capitol Hill, looks less than clinical: It’s a gray AirBnB hotel with cardboard hung in the windows. An industrial-size laundry detergent bucket next to the front door has “PCR SWAB COVID test” scrawled on the lid in black marker.

Dr. Eric Friedland, an emergency room physician at Overlake Medical Center, runs Covid Test Center out of a hotel room in Roy Street Commons, the budget lodging he and his wife operate. With travel down due to the pandemic, “I have an empty hotel, and I have, you know, knowledge and passion and this other ability,” Dr. Friedland said.

Dr. Friedland said he has drawn 400 people’s blood for antibody testing so far, at $129 each, to determine whether they have already had, and recovered from, Covid-19. He has also started offering $139 self-administered swabs for active infections. “We’re trying to do the right thing and help people,” Friedland said. “This isn’t a moneymaker for me.”

This facility is not regulated by the state. And, despite Dr. Friedland’s claims, its antibody test is not FDA-approved.

That a budget hotel has become a makeshift medical facility offering unproven antibody tests highlights the gaps in regulatory oversight at the local, state and federal levels during this pandemic.

“It’s a little bit of the Wild West,” said Cyndee Jones, the director of System Blood and Lab Services at Swedish Medical Center.

Jones said the race to identify cases of Covid-19 has led to tests, drugs and medical devices of dubious validity, and “definitely when it comes to these antibody tests, because there are so many people that are desperate to have access to a test, and they’re so scared.”

The FDA has allowed manufacturers to rush tests to market and bypass its usual approval process, which takes years and thousands of trials “to prove that the test really does meet a certain manufacturer’s claims,” Jones said. No antibody tests on the market are yet FDA-approved.

The FDA has granted less-stringent, fast-tracked Emergency Use Authorizations to 13 antibody tests which have gone through a shorter series of trials to prove their validity. Those tests can be marketed as “FDA-authorized.”

In the Seattle area, FDA-authorized antibody tests are available at the University of Washington Medical Center, The Polyclinic, Swedish, LabCorp and ZOOM+Care, which all rely on the authorized Abbott Laboratories test, and Quest Diagnostics, which uses its own authorized antibody test.

Covid Test Center, meanwhile, offers antibody tests from the company Diazyme. Asked why he advertises those tests as “FDA approved” - a threshold no antibody test has passed - Dr. Friedland admitted that was false. Instead, he claimed, the Diazyme tests are FDA-authorized.

“They are almost done with their FDA approval,” Dr. Friedland said. “That should have been done at the end of last week, or this week.”

In fact, said FDA spokesperson Jim McKinney, the Diazyme tests have met neither bar: they are neither approved nor authorized.

As with most antibody tests on the market, McKinney said, the FDA “does not intend to object” to the sale of the Diazyme tests due to the agency’s current emergency policy, which allows tests to enter the market with only the manufacturer’s assurance that it has tested their accuracy.

That is a low bar, said Jones. “It kind of means somebody said ‘Yeah, I put this thing together. And I, Joe Blow, say it works.’ And then they just sell it without all of the testing to prove that it actually meets any claims," she said.

Studies have shown that many such antibody tests are highly inaccurate, with a large percentage of false positive results. False positives can make people think that they have already had Covid-19, and may now be immune to the disease. Instead, they may just have antibodies from having fought off a different coronavirus, like the common cold.

“It scares me that people would use something that’s not in either of these categories (FDA-authorized or FDA-approved) and then use that to base decisions for their life and their health on something that has no validation testing to speak of,” Jones said.

It is not yet known whether past Covid-19 infections protect people from reinfection, and if so, how long that immunity might last. However, the Covid Test Center website assures prospective patients that “A positive test means you have had the virus. You are most likely protected.”

Although Washington State Department of Health provides regulatory oversight to medical facilities, spokesperson Jessica Baggett said that Covid Test Center does not qualify for oversight because specimens collected there are analyzed off-site.

“Department of Health does not regulate COVID-19 collection facilities, however, we regulate the laboratories in which samples are processed,” the DOH said in a written statement.

Covid Test Center sends blood and nasal swabs to a lab called US BioTek, in Shoreline, which specializes in food sensitivity testing for alternative medicine practitioners.

US BioTek is the subject of a pending state DOH investigation. Baggett would not give details regarding the investigation, but said it does not involve Covid-19 testing, and is related to US BioTek’s laboratory director, Dr. Stephen Markus.

Dr. Friedland has no apparent connection to the investigation into US BioTek, and said he was not familiar with its lab director. He said he got involved with the company through a friend who sits on the US BioTek board of directors.

"They consulted with me about getting machines for testing. And so I got involved in their process, and then their marketing," Dr. Friedland said.

The Washington Medical Quality Assurance Commission is investigating Dr. Markus for his alleged involvement in a scheme to bilk drug rehabilitation patients and insurance companies out of large sums for unnecessary urine drug screens. Markus did not respond to request for comment, but according to a statement of charges, Markus has said he was unaware of the scheme and that others carried it out by forging his signature.

US Biotek CEO Jack Frausing said he only learned of the state investigation into his company from KUOW, and that he had been unable to determine the nature of the complaint. He declined to comment on the allegations against his laboratory director and said they do not involve US BioTek.

It is not the first legal trouble involving a past or present US BioTek official.

The founder of the lab, and, until two years ago, its CEO, Raymond Suen, has a 2003 felony conspiracy conviction for selling an unapproved drug: OvImmune, a chicken egg powder marketed as a cure for conditions ranging from autism to AIDS. Suen also had federal criminal and civil convictions in 1994 for manufacturing and distributing moldy injectable drugs and illegally manufacturing anabolic steroids.

Those convictions involved two of Suen’s other businesses, Meridian Valley Clinical Laboratory and a Kent pharmacy called For Your Health.

Frausing said he had heard rumors about his predecessor’s legal problems, but noted that they did not involve US BioTek.

Frausing said the Diazyme test his lab offers is high-quality and more thorough than most on the market. But he said when he learned last week that Covid Test Center was advertising the Diazyme test as FDA-approved, “it surprised me a little bit,” because his lab includes a disclaimer on every test report that says the FDA has not reviewed the validity of the antibody test.

“When I found out, I called [Dr. Friedland] and I said ‘You’ve got to change that phrasing,” Frausing said. “So yeah, he was wrong on that one.”

Covid Test Center continues to advertise its antibody tests as FDA-approved.

University of Washington pharmacy professor Rodney Ho said it’s tough for the FDA to stay on top of all of the false claims made by people selling Covid-19 products and services.

“It’s like computer hackers, right? You try to catch them, but you’re always behind the eight-ball,” Ho said. “The FDA doesn’t have enough staff to police it.”

Ho said there may also be an uptick in the number of physicians hanging a shingle to offer Covid-related goods and services due to the sudden drop in demand for elective procedures and routine medical appointments.

Along with many other Americans, Ho said, some physicians “are in dire straits as well, because they are not getting the pay they’re used to getting in normal circumstances.”

Jones said when it comes to Covid Test Center, she sees a lot of red flags: The laundry detergent bucket used to collect lab specimens. The false claims of FDA approval. A state investigation into the laboratory doing the analysis.

“I really recommend people do their due diligence, do some investigation before just going to a pop-up someplace,” Jones said. She advises finding a longstanding, established medical facility that is offering a test that is FDA-authorized.

At Covid Test Center, though, Dr. Friedland said he’s serving a valuable role, helping to test people who are unable to find testing elsewhere, or to get their insurance to pay for it.

“Maybe,” he said, “the story is about a crazy ER doctor who’s trying to do the right thing in the middle of a pandemic.”

Anna Boiko-Weyrauch contributed reporting.

Update 9/9/20 3:06 pm - An Overlake Medical Center spokesperson notified KUOW that Eric Friedland stopped working at the facility at the end of June, after this story published.