Los Altos Med Tech Exec Guilty in $77M COVID-19 and Allergy Testing Scam

A federal jury convicted the president of a Silicon Valley-based medical technology company Sept. 1 of participating in a scheme to mislead investors, commit health care fraud, and pay illegal kickbacks in connection with the submission of over $77 million in false and fraudulent claims for COVID-19 and allergy testing.

Mark Schena, 59, of Los Altos, president of Arrayit Corporation, was convicted of one count of conspiracy to commit health care fraud and conspiracy to commit wire fraud, two counts of health care fraud, one count of conspiracy to pay kickbacks, two counts of payment of kickbacks, and three counts of securities fraud.

According to court documents and evidence presented at the trial in U.S. District Court in San Jose, Schena engaged in a scheme to defraud Arrayit’s investors by claiming that he had invented revolutionary technology to test for virtually any disease using only a few drops of blood.

In meetings with investors, prosecutors showed that Schena and his publicist claimed that Schena was the “father of microarray technology” and falsely stated that he was on the shortlist for the Nobel Prize. The evidence at trial showed that Schena also falsely represented to investors that Arrayit could be valued at $4.5 billion based on purported revenues of $80 million per year.

“The Covid-19 pandemic presented our communities, our country, and indeed the world with profound challenges to our health care systems,” said U.S. Attorney Stephanie M. Hinds in a post-trial statement. “Mark Schena preyed on investors, customers, and the health care industry by claiming he was helping us all to meet some of these challenges.”

“In fact, Schena committed federal crimes by, among other things, defrauding investors, receiving illegal kickbacks, disseminating deceptive marketing, and submitting fraudulent claims for reimbursement of unnecessary testing,” Hinds said.

“Mark Schena defrauded investors, and health care insurance programs, then turned to exploit the pandemic with a Covid-19 test that returned inaccurate results and placed public safety at risk,” said FBI San Francisco Special Agent in Charge Sean Ragan. “The FBI, DOJ, and other federal law enforcement partners will identify and investigate anyone-from the street to a corporate boardroom-who capitalizes on any national emergency to commit fraud and threaten the integrity of the securities market.”

“Mr. Schena’s conviction holds him accountable for a multi-million dollar fraudulent scheme driven purely by greed and devoid of concern for his unwitting patients or financial backers,” said Bryan D. Denny, Special Agent in Charge for the Department of Defense (DoD) Office of Inspector General, Defense Criminal Investigative Service (DCIS), Western Field Office.

“Mark Schena orchestrated a wide-ranging fraud scheme to boost his profits by exploiting the American public’s trust, paying illegal kickbacks, and submitting millions in false claims to Medicare,” said Special Agent in Charge Steven J. Ryan of the U.S Department of Health and Human Services Office of Inspector General (HHS-OIG).

Hinds said in a statement that the evidence at trial showed that Schena, among other things, failed to release Arrayit’s SEC-required financial disclosures and concealed that Arrayit was on the verge of bankruptcy.

Schena then lulled investors who were concerned that the company was a “scam” by inviting them to private meetings and issuing false press releases and tweets stating that Arrayit had entered into lucrative partnerships with companies, government agencies, and public institutions, including a children’s hospital and a major California health care provider.

The tweets and press releases falsely claimed that such entities had agreed to use the Arrayit technology, when in fact no such agreements existed or were of minimal value.

Prosecutors also said that Schena had orchestrated an illegal kickback and health care fraud scheme that involved submitting fraudulent claims to Medicare and private insurance for unnecessary allergy testing

Arrayit ran allergy screening tests on every patient for 120 different allergens (ranging from hornet stings to codfish) regardless of medical necessity. In order to obtain patient blood specimens, Schena paid kickbacks to marketers in violation of the Eliminating Kickbacks in Recovery Act and orchestrated a deceptive marketing plan that falsely claimed that the Arrayit test was highly accurate in diagnosing allergies, when it was not, in fact, a diagnostic test.

Arrayit billed more per patient to Medicare for blood-based allergy testing than any other laboratory in the United States, the evidence at trial showed, and billed some commercial insurers over $10,000 per test.

In early 2020, Arrayit’s allergy testing business declined because the COVID-19 pandemic and stay-at-home orders reduced demand for allergy testing, according to prosecutors.

Schena then falsely announced that Arrayit “had a test for COVID-19” based on Arrayit’s blood testing technology, before developing such a test. Seeking to capitalize on the nationwide shortage of COVID-19 testing,

In a statement, Hinds said Schena orchestrated a deceptive marketing scheme that falsely claimed that Dr. Anthony Fauci and other prominent government officials had mandated testing for COVID-19 and allergies at the same time and required that patients receiving the Arrayit COVID-19 test also be tested for allergies.

Schena also falsely claimed that the Arrayit COVID-19 test was more accurate than a PCR test for diagnosing COVID-19 infections, while concealing from investors and patients taking the test that the Food and Drug Administration had informed him that the Arrayit test was not accurate enough to receive an Emergency Use Authorization for use in the United States.

He is scheduled to be sentenced Jan. 30, and faces a maximum penalty 20 years imprisonment for the conspiracy to commit health care fraud and conspiracy to commit wire fraud; 10 years of imprisonment for each count of health care fraud; five years imprisonment for conspiracy to pay kickbacks; 10 years imprisonment for each count of payment of kickbacks; and 20 years imprisonment for each count of securities fraud. U.S. District Judge Edward J. Davila will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

One Comment

  1. The government’s own “Pump & Dump” scheme.

    Drive the populace to irrational fears so that they test weekly, hourly, even daily and even more-so when they get a runny nose or headache.

    The entire Government and CDC oversight, management and implementation of Covid policy, has been a disaster across the country and waste of taxpayer dollars in so many ways and programs.

    I think I even have a couple boxes of “Free” USPS Covid tests that I ordered in the mail somewhere on a shelf unopened.

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