The breadth of foundational technologies used in the development of in vitro diagnostic assays continues to expand and diversify beyond conventional lateral flow and immunoassays. From molecular diagnostics based on polymerase chain reaction and next generation sequencing, to those incorporating CRISPR-based gene editing, strategies used in the design of these tests increasingly take advantage of novel and potentially disruptive technologies at the forefront of innovation.
Download this app note to learn more about the key considerations about for the use of novel molecular diagnostics such as:
- Ensuring supply and integrity of raw materialsDo they produce their own raw materials?
- Understanding the regulatory requirements of both the raw materials and the final productWhat are the costs of their raw materials?
- Preparing for commercial success