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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Houston High School Student Starts Lab Business and Takes COVID-19 Rapid Antigen Testing on the Road with Mobile Clinical Laboratory

Taft Foley, III, says he got the idea for the mobile lab after waiting on a COVID-19 testing line that went ‘around the entire building’

In a remarkable example of ingenuity and observation, Texas high school student Taft Foley, III, is bringing COVID-19 testing to underserved patients, wherever they may be. He launched a medical lab company, then developed a mobile clinical laboratory which performs rapid antigen tests that can detect the presence of antigen in about 15 minutes.

Foley—who recently became an EMT after graduating from the Texas EMS Academy—designed his mobile medical lab to use Quidel Sofia SARS Antigen FIA tests (nasal swabs). Results are sent to patients by text or e-mail. Foley also works with CLIA-certified Baylor Genetics Laboratories on COVID-19 (SARS-CoV-2) RT-PCR molecular testing, which gives his customers results in 24 to 48 hours, Forbes reported.

Foley, who is 18-years-old and an Eagle Scout, said he got the idea to launch the mobile COVID-19 testing business after he went for a coronavirus test and had to wait on a line that “wrapped around the entire building,” ABC13 reported. “I said to myself, ‘There needs to be a better way,’” Foley told ABC13.

Forbes reported that Texas Mobile Medical Labs allocates a portion of test fees paid ($100 to $150/test) to help provide tests to the homeless and others who need them, such as veterans and senior citizens.

“The (majority of) tests have been done at businesses who appreciate our mobile capabilities. We arrive and test all employees onsite and have their results back in 15 minutes,” Foley told Forbes.

Taft Foley, III and his medical lab van
After raising $60,000 through events and sale of personal items, Taft Foley, III (above), purchased a van and rapid antigen tests, reported The Kinkaid Falcon. “I think that that idea is hopefully going to galvanize a lot of good things, because we as humans, we’re good at learning from one another. If my idea is good enough to inspire others to create their own businesses and ideas for the betterment of the community, then I’m all for it,” Foley told the Falcon. (Photo copyright: Texas Mobile Medical Labs.)

Other States with Mobile COVID-19 Testing

Texas is not the only state where savvy entrepreneurs like Foley and health agencies are offering mobile COVID-19 testing.

In May, Florida Gov. Ron DeSantis announced Statlab Mobile, a COVID-19 mobile laboratory out of Miami that tests people in skilled nursing and long-term care facilities and other areas of the Sunshine State.

“We believe this will be a game-changer (in long-term care),” DeSantis told the Miami Herald.

“The idea was to bring help to those who are vulnerable, those who can’t otherwise get the kind of medical information they would otherwise love to have,” Bryan Wilson, Statlab Chief Executive Officer, told Patch, which noted the tests are free.

Statlab Mobile van
Statlab Mobile (above) can perform about 3,500 Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV coronavirus tests per week, according to the Florida COVID-19 Testing website. Statlab works with Florida’s Division of Emergency Management, the National Guard, and contracted nurses to conduct coronavirus testing throughout Florida. (Photo copyright: Statlab Mobile.)

Mobile COVID Testing in Other States

Mobile medical laboratories are being deployed to help handle surges of COVID-19 cases in Massachusetts, New Jersey, and Arizona, as well.

In Massachusetts, testing vans operated by American Family Care (AFC), an urgent care provider, started heading out in November to schools and businesses state-wide with a goal to test at least 100 to 150 people daily for COVID-19, according to The Reminder.

The vans are staffed by medical providers who test people with Abbott’s BinaxNOW COVID-19 Ag Card, AFC told The Reminder. The rapid antigen test offers results in 15 minutes.

In September, Dark Daily reported that the US federal Department of Health and Human Services (HHS) awarded a $760 million contract to Abbott for 150 million rapid antigen tests to aid in detection of COVID-19 as workplaces and schools reopen.

“We’ve had several companies who would like to schedule their employees to be tested on a regular basis. But they also want to be able to make sure that if there is a potential contamination within their businesses, they have a resource to utilize to make sure they can test people right away,” Jim Brennan, Owner/CEO of Medvest, LLC, AFC urgent care’s parent company, told The Reminder.

And in Phoenix, a COVID-19 mobile medical van provides testing to underserved communities. The City of Phoenix, along with staff from the Vincere Cancer Center, use Quidel’s Sofia SARS Antigen FIA test at public and private locations and at family services centers, AZ Central reported.

Clearly, mobile COVID-19 testing labs are here to stay. They serve seniors and vulnerable populations challenged to access clinical laboratory testing at traditional locations and at COVID-19 drive-through sites. And on larger scales, mobile medical laboratories have become key resources to address coronavirus case surges and to conveniently test people at businesses and schools to help identify symptomatic individuals who should be quarantined.

Clinical laboratory managers may be impressed by how quickly mobile testing companies and entrepreneurs form partnerships with public health agencies toward making COVID-19 tests available to all at places where people live and work.

—Donna Marie Pocius

Related Information:

Houston Teen Launches Mobile COVID-19 Testing Lab

Texas EMT, 18, Opens Mobile COVID-19 Testing Lab

Taft Foley III, 18-Year-Old, Makes Mobile COVID-19 Testing Lab

TAFT Foley, ’21, Creates Mobile COVID-19 Testing Center

DeSantis Announces New COVID-19 Antibody Testing, Sanitizing and Lab on Wheels

Fast Coronavirus Lab Results in Florida Through Statlab Mobile

AFC Deploys COVID-19 Mobile Testing Vans in Community

Free Phoenix COVID-19 Mobile Testing Van Gives Results in 15 Minutes

U.S. Government Purchases 150 Million COVID-19 Antigen Tests from Abbott Laboratories for $760 Million; Only CLIA-Certified Laboratories Can Do Testing

Two Florida Clinical Laboratory COVID-19 Test Contracts Come Under Scrutiny

One medical testing company was led by a convicted felon, another was accused of delays and unreliable results

Like many states, Florida has worked hard to quickly ramp up diagnostic testing for SARS-CoV-2, the coronavirus that causes the COVID-19 illness. For the most part this has been a good thing. However, local media in that state reported problems with two no-bid contracts for clinical laboratory testing, including one with a Dallas-based company whose founder pleaded guilty last year to two felonies involving insurance fraud.

In a press conference announcing the two deals, Florida Governor Ron DeSantis said, “We have two contracts in place with two new labs that will increase our lab capacity by 18,000 samples per day.” He added that he expected a 24- to 48-hour turnaround.

“That’s a lot better than we’ve been getting from Quest and LabCorp,” he said. “These labs will be primarily where we send our samples that we collect in the long-term-care and assisted-living facilities and at the community-based walk-up sites.”

The announcement followed DeSantis’ March 9 emergency decree, which allowed state agencies to award contracts to companies without undergoing formal bidding processes, reported Florida Bulldog, an independent non-profit news site.

In his announcement, DeSantis did not identify the companies that had received the lab test contracts. However, Florida Bulldog reported that those companies were:

  • Indur Services, a Dallas-based health-coaching company, and
  • Southwest Regional PCR, a CAP-accredited lab in Lubbock, Texas, that does business as MicroGenDX Laboratory (MicroGen Diagnostics, LLC).

The Indur contract—initially valued at $11.3 million—included $10.2 million for 140,000 COVID-19 RT-qPCR test kits, plus additional payment for supplies, Florida Bulldog reported based on information from the state contract database. Later, the contract was reduced to $2.2 million solely for supplies.

The MicroGenDX contract—valued at $11 million—called for 8,000 tests per day for 14 days at a cost of $99 per test, Florida Bulldog reported. That contract was later cancelled due to concerns about reliability and processing speed.

Indur’s Legal Troubles

Indur is a self-described “health and wellness lifestyle and products company” founded in 2017 by Brandt Beal, according to Business Insider. In 2019, Beal pleaded guilty to two felonies involving insurance fraud in Texas and was given 10 years’ probation in each case, Florida Bulldog reported. He also was required to pay restitution. He pleaded guilty to a separate charge of felony theft in 2017 and was sentenced to nine years’ probation.

In an interview with Florida Bulldog, Beal claimed that “the man who pleaded guilty to those charges is actually his cousin with the same name.” However, Beal “would not provide requested contact information for his cousin,” the Florida Bulldog reported, which posted photos demonstrating that the Indur founder and the person who pleaded guilty to the felonies were the same individual.

Jason Mahon, Communications Director at FDEM
Jason Mahon, Communications Director at the Florida Division of Emergency Management (above), told Florida Bulldog that Indur’s COVID-19 testing contract was scaled back in May “because Indur Services did not provide testing directly, but rather was providing testing services through another company.” The state then contracted directly with that clinical laboratory company to obtain the COVID-19 testing services. “Time is of the essence when securing these critical testing supplies for Floridians, and that limited time does not allow for the Division to vet every company’s executive leadership or board of directors,” Mahon told Florida Bulldog. (Photo copyright: LinkedIn.)

The amended contract, valued at $2.2 million, called for Indur to deliver swabs and vials. “To date, everything that’s been ordered they’ve delivered on,” said Jared Moskowitz, Director of the Florida Division of Emergency Management department.

Testing Delays Snag MicroGen Diagnostics

The state cancelled its contract with MicroGenDX on May 15, Florida Bulldog reported.

“As with any lab, we do our due diligence to ensure the company will be able to provide reliable services before sending any samples,” said Jason Mahon, Communications Director at the Florida Division of Emergency Management. “Upon further interaction with this vendor, the Division determined that the state could not be 100% confident in the results that would come from this vendor, or with the processing speed, which is critical for COVID-19 testing.”

This came as AdventHealth, a non-profit health system based in Altamonte Springs, Fla., was having its own difficulties with MicroGenDX.

On May 16, AdventHealth announced that it had terminated a COVID-19 testing contract with an unnamed third-party lab, claiming that the provider was “unable to fulfill its obligation.” Multiple media outlets later revealed MicroGenDX as the third-party lab, and USA Today reported that the FDA had launched an investigation.

“This issue impacts more than 25,000 people throughout Central Florida,” stated an AdventHealth press release. “This situation has created unacceptable delays and we do not have confidence in the reliability of the tests.” AdventHealth said it would contact affected individuals about the need for retesting.

However, MicroGenDX CEO Rick Martin refuted the health system’s claims. “You can go after me because I didn’t meet your capacity and I couldn’t deliver on your drive-through testing because of things that I couldn’t control, but don’t attack the reliability of my test,” he told the Orlando Sentinel.

According to MicroGenDX, the company received an emergency use authorization (EUA) from the FDA on April 23 for an internally-developed RT-PCR test that can be performed on nasal swabs or sputum samples, noted a press release. The tests are run in the company’s lab facility in Lubbock, Texas.

One factor in the dispute was the handling of patient samples, USA Today reported. Martin told reporters that representatives from AdventHealth had visited the lab and observed samples that were stored at room temperature. “[Martin] maintains the samples were still valid and that the delays were due to AdventHealth not providing proper patient data and the lab running out of plastic parts used in its equipment,” noted USA Today.

Mahon told Florida Bulldog that the state did not send samples to MicroGenDX for processing. And the Florida Bulldog reported that Martin said his lab was so “hammered with huge volumes of samples” that he would have turned down any requests, adding that Martin “stood by the reliability and accuracy of his firm’s testing and said he looks forward to a day of vindication after federal inspectors conduct any inquiries.”

Martin has had his own legal troubles. According to USA Today, he was indicted by the US Department of Justice Middle District of Florida in 2017 for participating in a kickback scheme while working as a sales rep for Advanced BioHealing, Inc., of Westport, Conn. However, Martin was acquitted in a February 2019 trial, and Advanced BioHealing’s CEO Kevin Rakin settled the False Claims Act allegations for $2.5 million.

Collectively, these news stories scratch the surface of a bigger situation involving COVID-19 laboratory testing. The fact that Congress authorized billions of dollars to fund COVID-19 testing was noticed by some individuals who saw the funding as an opportunity to “make a quick buck” if they could get contracts to provide COVID-19 testing—whether they owned a CLIA-certified complex laboratory or not.

Thus, it’s no surprise that more companies are bidding on COVID-19 testing contracts. What remains unknown is how many of those companies are actively soliciting COVID-19 testing contracts throughout the United States.

Given this situation, and the facts recounted above, it is reasonable to ask an obvious question: Why did Florida state officials not do a more rigorous check into the credentials of the clinical laboratory entities they were preparing to award no-competitive-bid contracts to for COVID-19 testing?

—Stephen Beale

Related Information:

DeSantis Bragged about Deal with Lab Firm Now at Center of COVID-19 Testing

FDA Investigates Lab as Tens of Thousands of COVID-19 Test Results in Florida Are Questioned

TDI: Ex-Insurance Agent Funneled Wichita Falls Dairy Firm’s Premiums into His Own Pocket

More Rapid Tests Are Coming to FL. COVID-19 Testing Capacity Will Double, DeSantis Says

MicroGenDX CEO: ‘No Reason’ to Doubt COVID-19 Tests for Central Florida AdventHealth Patients

Lab Says 25,000 COVID-19 Tests Are Reliable, Disputing AdventHealth Claims

Nearly 35,000 Coronavirus Tests in Florida Cannot Be Processed

AdventHealth: 25,000 COVID-19 Test Results in Central Florida Are ‘Unreliable’

Florida Health Care System: 35,000 Virus Tests ‘Unreliable’

A Doctor Was Hired to Tell People They Had Coronavirus. He Had Checkered Past.

How a St. Petersburg Company with No History in Medical Supplies Won a $10 Million Coronavirus Contract