The president of a Silicon Valley-based medical technology company was sentenced today to eight years in prison and ordered to pay $24 million in restitution for participating in a scheme to defraud investors and a scheme to commit health care fraud and pay illegal kickbacks in connection with the submission of over $77 million in claims for COVID-19 and allergy testing.
“A Silicon Valley executive exploited the pandemic for profit, ultimately endangering patients with unproven COVID-19 tests,” said Acting Assistant Attorney General Nicole M. Argentieri of the Justice Department’s Criminal Division. “The Department of Justice is committed to protecting the people of this nation by investigating and prosecuting those who put public health at risk and use global emergencies to line their own pockets.”
“Schena put profit over public safety. He used the global pandemic as a backdrop to fuel a kickback scheme and a massive fraud upon investors and people searching for better health care during a time of great uncertainty,” said U.S. Attorney Ismail J. Ramsey for the Northern District of California. “Even in times of national crisis, our office will ensure that Silicon Valley remains a place where innovation and ingenuity – and not fraud and deceit – fuel vibrant markets for investors and inventors.”
According to court documents, Mark Schena, 60, of Los Altos, California, was the president of Arrayit Corporation. Schena engaged in a scheme to defraud Arrayit’s investors by claiming that he had invented a revolutionary technology to test for virtually any disease using a single drop of blood from a finger stick sample. In meetings with investors, Schena and his publicist claimed that Schena was the “father of microarray technology” and that he was on the shortlist for the Nobel Prize. Schena also falsely represented to investors that Arrayit could be valued at $4.5 billion.
“Today’s outcome illustrates HHS-OIG’s unwavering commitment to protecting federal health care programs under any circumstance – especially when a public health emergency presents opportunities for bad actors to exploit,” said Deputy Inspector General for Investigations Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “We continue to work tenaciously with our law enforcement partners to bring to justice those who have constructed schemes to take advantage of the COVID-19 pandemic for personal gain.”
“Every time there’s a disaster of some type, scammers climb out of the woodwork with schemes to bilk people out of their money,” said Postal Inspector in Charge of Criminal Investigations Eric Shen of the U.S. Postal Inspection Service (USPIS). “In this case, Mark Schena and the Arrayit Corporation were already involved in deceiving the public before the COVID-19 pandemic hit. When the pandemic hit, the company then attempted to develop a COVID-19 antibody test but were unsuccessful. Despite having no product and on the verge of bankruptcy, Schena continued to defraud investors, claiming to have multimillion-dollar contracts and other business developments that all proved to be bogus.”
In furtherance of the scheme, Schena failed to release Arrayit’s financial disclosures – as required by the Securities and Exchange Commission (SEC) – and concealed that Arrayit was on the verge of bankruptcy. Schena lulled investors who were concerned that the company was a “scam” by engaging in television appearances and filming videos that fraudulently portrayed the laboratory as busy and high-tech. Schena also issued false press releases and public statements on social media 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 press releases and statements falsely claimed that such entities had agreed to use the Arrayit technology, when in fact no such agreements existed or were of minimal value.
“Those who used the pandemic for illicit profit by engaging in health care fraud and defrauding investors must face the consequences of their actions,” said Assistant Director Luis Quesada of the FBI’s Criminal Investigative Division. “The FBI and its partners will work relentlessly to protect the American people from abuses to our financial and health care systems, and this sentencing reflects those efforts.”
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 regardless of medical necessity. 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. The Health Care Fraud Unit’s Data Analytics Team supported the prosecution and, as the evidence at trial showed, Arrayit billed more per patient to Medicare for blood-based allergy testing than any other laboratory in the United States.
“This sentence holds the defendant accountable for his large-scale fraud scheme that impacted multiple federal agencies and robbed the taxpayers of millions of dollars,” said Inspector General Michael J. Missal of the Department of Veterans Affairs Office of Inspector General (VA-OIG). “The VA-OIG will continue to work zealously with our law enforcement partners to ensure schemes like this are uncovered, investigated, and prosecuted to the fullest extent of the law.”
“Mr. Schena’s sentencing is a fitting resolution that holds him accountable for a multimillion-dollar fraudulent scheme driven purely by greed and devoid of fiscal responsibility or concern for the patients that would ultimately use his nearly useless products,” said Director Kelly P. Mayo of the Department of Defense (DoD) Office of Inspector General, Defense Criminal Investigative Service (DCIS). “DCIS remains committed to working with its partners to identify and eliminate fraudulent schemes that potentially endanger patient safety and corrupt the integrity of TRICARE, the DoD’s health care program.”
In early 2020, Schena falsely announced that Arrayit “had a test for COVID-19.” Schena told federal agents that it was simple to develop a test for COVID-19 because the switch from testing for allergies to testing for COVID-19 was “like a pastry chef” who switches from selling “strawberry pies” to selling “rhubarb and strawberry pies.” 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 concealed from investors and patients 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.
A federal jury convicted Schena on Sept. 6, 2022.
The HHS-OIG’s San Francisco and Detroit Regional Offices, USPIS, FBI, VA-OIG, and DCIS investigated the case.
Principal Assistant Chief Jacob Foster and Trial Attorney Laura Connelly of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Christina Liu for the Northern District of California prosecuted the case.
The Fraud Section leads the Criminal Division’s efforts to combat health care fraud through the Health Care Fraud Strike Force Program. Since March 2007, this program, comprised of 15 strike forces operating in 25 federal districts, has charged more than 5,000 defendants who collectively have billed federal health care programs and private insurers more than $24 billion. In addition, the Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to hold providers accountable for their involvement in health care fraud schemes. More information can be found at www.justice.gov/criminal-fraud/health-care-fraud-unit.
The Fraud Section uses the Victim Notification System (VNS) to provide victims with case information and updates related to this case. Victims with questions may contact the Fraud Section’s Victim Assistance Unit by calling the Victim Assistance phone line at 1-888-549-3945 or by emailing Victimassistance.fraud@usdoj.gov. To learn more about victims’ rights, please visit www.justice.gov/criminal-vns/victim-rights-derechos-de-las-v-ctimas. If you believe you are a victim who has invested in Arrayit, or you have taken a COVID-19 test prepared or marketed by Arrayit, please visit www.justice.gov/criminal-vns/case/Arrayit.
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