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Considerations When Developing Diagnostic Assays Using Leading-Edge Technologies

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 for the use of novel molecular diagnostics such as:

  • Ensuring supply and integrity of raw materials
  • Understanding the regulatory requirements of both the raw materials and the final product
  • Preparing for commercial success