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I-TEAM uncovers unsettling background behind COVID-19 antibody testing site

Wednesday, June 10, 2020

I-TEAM uncovers unsettling background behind COVID-19 antibody testing site

After several complaints about a coronavirus antibody testing site in San Jose, TestMe2, the ABC7 I-TEAM did some research. Here's what Dan Noyes found in his investigation.

SAN JOSE, Calif. (KGO) -- In such uncertain times, many of us are trying to figure out if we've been exposed to coronavirus.

Do I have antibodies that could help prevent a future infection?

Drive-thru testing sites are popping up.

One viewer called me with concerns about a new testing company. I quickly found half a dozen customers with the same complaints.

This East Bay mom doesn't want to be identified because of medical privacy, but she has concerns about a drive-thru COVID-19 antibody testing site in San Jose called "TestMe2."

Her six-year-old son misses his grandparents during the shelter-in-place, and she thought a coronavirus antibody test would give her some confidence that a visit would be safe.

"He said, 'Mommy, Daddy, can you please go get one because if we have antibodies, if we did have it, then we can see our grandparents again.' He wanted it, so part of it was his plea, which was heartbreaking."

The company promised no out-of-pocket expenses - they'd bill insurance - and test results in 2-3 days. She's been waiting a month.

"It does make me question the legitimacy, especially because I know that several people who have gone for testing either on that day or since have also tried to get answers."

I began digging. On the TestMe2 website, you can book an appointment, but you won't find identifying information - no person's name, no phone number, no email or address.

I tried to click their Privacy Policy or Terms of Service and it didn't go anywhere.

A few searches later, I found TestMe2's owner, Vince Thayer, who calls himself a "serial entrepreneur." His chief innovation officer, Ryan Hendrickson, former Bay Club personal trainer; now, a "telemedicine expert," misspelled.

I stopped by the TestMe2 site in the parking lot of a defunct radio station on a recent Sunday, and there's Thayer and Hendrickson. They're happy to chat and allow me to get pictures, with the clients' permission, of the finger-prick blood test. While I'm there, Effat Yousefi pulls up. Her results are also overdue.

Effat Yousefi, TestMe2 Customer: "They haven't sent me anything yet."

Dan Noyes: "So, it's been over a week?"

Effat Yousefi, TestMe2 Customer: "Over a week, yeah."

Dan Noyes: "How quickly do you turn around the tests?"

Vince Thayer: "So, as soon as we get into the lab, they have a 72-hour turnaround."

Dan Noyes: "72 hours."

Thayer and Hendrickson explain they get as many as 150 customers a day, and their doctors are overwhelmed.

Dan Noyes: "I've talked to several people who haven't gotten their tests. And it's been weeks. Why is that?"

Ryan Hendrickson: "So, we actually, we're required to follow up with all positives within four days, 96 hours. However, we actually do have a bit of a backup with our negatives."

They told me the bottleneck is with their physicians who have to review the results, and I asked for names. First, Dr. Adam Gratz.

Vince Thayer said, "And he actually is the one that's running Project Baseline with Verily."

That's impressive. Verily Life Sciences is Google's sister company, and Dr. Gratz' Linkedin says he is "Verily's Site Medical Lead."

But, a Verily spokesperson tells me, Gratz actually works for a sub-contractor, and that, "Verily does not work with TestMe2 at all, and they shouldn't be making comments about Verily's program or Adam's role in the program."

I also met TestMe2's Interim Medical Director, Dr. Abdelsalam Mogasbe.

Ryan Hendrickson said, "Yeah, he's actually had a really good track record of working with people in the senior care centers in skilled nursing facilities."

Dr. Mogasbe was actually indicted along with several others in 2018, on federal charges of conspiring to receive kickbacks for referring patients to a home healthcare agency.

A Federal Court clerk said, "United States of America versus Abdelsalam Mogasbe."

I found a recording of his arraignment from San Jose Federal Court; they'll be setting a trial date next month.

Mogasbe's lawyer told the judge, "The plea will be not guilty."

Next, I wanted to know the name of the company that provides those test kits and processes the blood samples. Thayer and Hendrickson wouldn't say.

Vince Thayer told me, "They don't really want to be scrutinized with the press and everything going through all the approval process that we're doing right now."

They did say it's a Silicon Valley company. I checked the FDA's list for local labs, and found one with a test kit I had seen before - at the TestMe2 site.

It's Arrayit of Sunnyvale. Owner Mark Schena didn't return my messages, so I stopped by the lab. He happened to walk out on a call, and then agreed to an interview.

Dan Noyes: "Explain to me how the TestMe2 relationship came about."

Dr. Mark Schena: "I'm sorry?"

Dan Noyes: "The TestMe2 relationship?"

Dr. Mark Schena: "That, I'm not familiar with."

Dr. Schena told me he has a 1,400-clinic network, and he's not familiar with each one. TestMe2 later confirmed they use the Arrayit antibody test kits. Dr. Schena told me his lab takes two to three days to process a test, so he doesn't know why TestMe2 results would be so delayed sometimes.

I also wanted to know why Arrayit's stock price has hovered around a penny, and why the company faced action by the Securities and Exchange Commission.

Dan Noyes: "Explain to me why the stock was taken off the market in April."

Dr. Mark Schena: "Right, um, you know, I obviously, you probably know as much as we do."

The SEC halted trading in the company's stock, citing questions about its financial condition and operations, and claims in the marketplace that Arrayit "developed an approved COVID-19 blood test."

The FDA has not approved Arrayit's Covid-19 antibody test, nor has the FDA given an "Emergency Use Authorization" for it to be used during the pandemic. Dr. Schena tells me he has applied for an EUA.

Dr. Mark Schena: "What I can say is that we are working closely with the FDA, and we're following FDA guidelines for deploying the test."

Dan Noyes: "So, this hasn't been approved yet by the FDA."

Dr. Mark Schena: "That's correct."

He told me the test does detect covid antibodies. Then, I asked the most important question of all - are antibody tests worthwhile?

Dan Noyes: "The CDC said this week that the antibody tests may show that you were exposed, but it doesn't tell your immunity."

Dr. Mark Schena: "That's a very good point. ... It's true as a medical fact, we simply don't know that answer. But it's certainly worthwhile to know whether or not you have antibodies as a starting point."

While some tests are better than others, the CDC also now says COVID-19 antibody tests might be wrong up to half the time.

Several of the clients reached for this report say they did eventually get results, up to three weeks late. But that mom I talked to still hasn't received hers over a month later. She finally went to a different testing center and got her results back in twelve hours.

You can see the FDA's full statement on coronavirus antibody testing here.

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