iSeq 100

Waiver Rationale Summary

In Conclusion, The iSeq 100 is the most cost effective, robust and reliable option for Next Generation Sequencing to perform HIV drug resistance surveillance in PEPFAR-supported countries. The Illumina brand is well known and highly utilized among the scientific community for it’s standard of quality and availability for use in the United States as well as resource-limited countries supported by PEPFAR. The Illumina iSeqis the only low throughput sequencing technology that is not only portable and the smallest of its kind but has no internal mechanism that would require setup or maintenance by a licensed technician. Many field laboratories do not have the space for a high-throughput capacity NGS system, nor do they have access to specialized technicians that can help them set up and maintain an NGS system. The Illumina Miseq which currently resides in our laboratory is not cost-effective in the case where sample quantity is less than 96 samples per run. However, the Iseq can produce cost-effective results with less than 50 samples per run and is smaller and less expensive than all other Next Generation Sequencers of its kind. The Illumina iSeq will be used to validate sequencing data against the current Miseq, and Sentosa diagnostics systems for HIV Drug Resistance. Illumina is the most robust of all the current NGS technology companies, in that most off-brand companies also sell supplies and reagents, thus offering wide availability and cost savings. Illumina instruments are the number one NGS systems used at the CDC. Illumina is the only company that sells the iSeq.