Illumina NGS instrument software vulnerable to cybersecurity breach: FDA
Summary
The U.S. Food and Drug Administration (FDA) last week warned healthcare providers and laboratory personnel about a cybersecurity vulnerability affecting software in Illumina instruments that may be specified either for clinical diagnostic use in sequencing a person’s DNA for various genetic conditions or for research use only (RUO). An unauthorized user could exploit a vulnerability in the instruments Universal Copy Service (UCS) software by taking control remotely; altering settings, configurations, software, or data on the instrument or a customer’s network; or impacting genomic data results in the instruments intended for clinical diagnosis, the FDA said Thursday. On April 5, Illumina sent notifications to affected customers instructing them to check their instruments and medical devices for signs that the software vulnerability had been exploited. Additionally, Illumina has developed a software patch to protect against the cybersecurity vulnerability being exploited. The FDA said that it is working with Illumina to identify, communicate, and prevent adverse events related to the software vulnerability.