DOJ Reaches $9.8 Million Settlement with Genetic Testing Company Illumina Inc. to Resolve FCA Allegations
DOJ announced that genetic testing company Illumina Inc. will pay $9.8 million to resolve allegations that it sold genomic sequencing systems with cybersecurity vulnerabilities to the various federal Departments and agencies in violation of the FCA. According to DOJ Civil Division Assistant Attorney General Brett A. Shumate, “This settlement underscores the importance of cybersecurity in handling genetic information and the Department’s commitment to ensuring that federal contractors adhere to requirements to protect sensitive information from cyber threats.”
The settlement concludes a lawsuit launched by a qui tam complaint filed on September 8, 2023. The relator—formerly Director for Platform Management, On-Market Portfolio, at Illumina—alleged that Illumina failed to address known cybersecurity vulnerabilities that may have affected the confidentiality of patient data stored in its genomic sequencing systems. See United States ex rel. Lenore v. Illumina, Inc., 1:23-cv-00372 (D.R.I.).
According to DOJ, between February 2016 and September 2023, Illumina sold these genomic sequencing systems to federal agencies without putting in place a sufficient security program or quality systems. In the settlement agreement, the government contends that regardless of whether any cybersecurity breaches occurred, “the claims were false because Illumina knowingly failed to incorporate product cybersecurity in its software design, development, installation, and on-market monitoring; failed to properly support and resource personnel, systems, and processes tasked with product security; [and] failed to adequately correct design features that introduced cybersecurity vulnerabilities.” In addition, according to the government, Illumina falsely represented that its software met cybersecurity standards, such as those set by the National Institute of Standards and Technology.
The settlement agreement provides that Illumina will pay the government $9.8 million dollars, of which $4.3 million is restitution. The relator will receive $1.9 million of the settlement funds.
A copy of the settlement agreement can be found here.
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