CALIFORNIA
A federal jury convicted the president of a Silicon Valley-based medical technology company Thursday of misleading investors, committing health care fraud, and paying illegal kickbacks, officials announced Friday, officials stated.
The crimes were in connection with the submission of over $77 million in false and fraudulent claims for COVID-19 and allergy testing, according to authorities.
Mark Schena, 59, of Los Altos, California, served as the president of Arrayit Corporation.
According to court documents and evidence presented at trial, Schena used 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, 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 evidence at trial showed that Schena failed to release Arrayit’s SEC-required financial disclosures. He also concealed that Arrayit was on the verge of bankruptcy.
Schena 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.
Schena also 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. Also, he orchestrated a deceptive marketing plan that falsely claimed that the Arrayit test was highly accurate in diagnosing allergies when it was not, 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.
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, 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.
He concealed from investors and patients taking the test that the Food and Drug Administration informed him that the Arrayit test was not accurate enough to receive an Emergency Use Authorization for use in the United States.
Schena was convicted of the following crimes:
- 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.
- Three counts of securities fraud.
Schena is scheduled to be sentenced on Jan. 30. He is facing a lengthy prison sentence, according to officials.
The Department of Health and Human Services Office of Inspector General’s San Francisco Regional Office and Detroit Regional Office, U.S. Postal Inspection Service, the FBI, the Veterans Affairs Office of Inspector General and Defense Criminal Investigative Service investigated the case.
Acting Principal Assistant Chief Jacob Foster and Trial Attorney Laura Connelly of the Justice Department’s Fraud Section and Assistant U.S. Attorney Christina Liu for the Northern District of California are prosecuting the case.