FDA Provides Update on Illumina’s Cybersecurity Warning for Its Sequencing Software

The FDA has issued an update on Illumina’s May 3 urgent safety notification to its customers about a cybersecurity flaw in its sequencing software. The notice asked customers to check their instruments and devices for signs of potential exploitation of the vulnerability.

The affected software is in Illumina’s NextSeq 550Dx, MiSeqDx, NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq, all of which are next generation sequencing instruments for clinical diagnostic use in sequencing a person’s DNA or testing for various genetic conditions.

The agency said the company has developed a software patch and is working to provide a permanent software fix for current and future instruments. Neither the agency nor the company have received any reports indicating that this vulnerability has been exploited, the FDA said.