Reagent kits for the next generation of in situ sequencing

Purpose and goal

CARTANA´s goal with this project was to develop a new generation of products for our in-situ sequencing (ISS), which was fulfilled in its entirety. We have improved our technology and generated two new reagent kit products. The first (HS Library Preparation Kit) allows more tissue types to be analyzed including FFPE and has a significantly higher sensitivity than the previous version. The second is an ISS kit with which the users can generate ISS data themselves. We have conducted a broader market analysis and prepared a quality management system for manufacturing and production.

Expected results and effects

The HS Library Preparation Kit showed significantly improved sensitivity (5-10x depending on sample type) as well as application to several different species and tissue types, including FFPE. ISS Kit is designed to work regardless of the sample type being analyzed. Both products were launched in May 2020. CARTANA´s service business continues but several interested Core facilities have been contacted to increase customer´s access to ISS. A QMS and appropriate certification of manufacturing and production has been started. Increased interest in CARTANA has been noted by Pharma.

Planned approach and implementation

For the new and kits, several alternatives were evaluated after which the most promising went through extensive optimization, validation and product development. Patent applications have been submitted. In some cases, selected customers in areas other than neurology contributed to the development process, which provided valuable data on sample types. In validation, the new technologies were compared with previous products on the same samples. R&D reports and new standard operation procedures have been produced. An external consultant evaluated the need for a QMS.