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FDA Warns of Cybersecurity Vulnerability in Certain NGS Instruments

A glitch in the local run management software may open the door to hacking, agency says.

On June 2, the FDA issued a warning that may affect your lab if it uses certain Illumina next-generation sequencing instruments. The letter states that there might be a cybersecurity vulnerability affecting the local run management (LRM) software on the following Illumina instruments; NextSeq 550Dx; MiSeq Dx; NextSeq550; iSeq; and MiniSeq.

Although it hasn’t received any reports of actual incidents, the FDA says there’s a risk that hackers can exploit the vulnerability to:

  • Take control of the instrument remotely;
  • Alter settings, software, or data on the instrument or customer’s network; or
  • Impact patient test results.

Illumina has sent notifications and instructions to affected labs so they can check for hacking; it’s also created a software patch to prevent exploitation of the vulnerability as it works on a permanent fix. The FDA’s recommendations:

  • Review the Urgent Safety Notification or Product Quality Notification (for research use only [RUO] customers) Illumina sent to affected customers. If you didn’t receive a notification from Illumina, but think you should have, contact techsupport@illumina.com;
  • Immediately download and install the software patch (Dx mode and RUO mode) on every affected instrument, including in each stand-alone instance of the off-instrument LRM for RUO mode on the Dx instruments, while connected to the internet;
  • Contact techsupport@illumina.com for instructions on other ways to install the software patch, if you’re not connected to the internet; and
  • Immediately contact techsupport@illumina.com if you suspect your instrument may have been compromised by an unauthorized user.