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The breadth of foundational technologies used in the development of in vitro diagnostic (IVD) assays continues to expand and diversify beyond conventional lateral flow and immunoassays.

From molecular diagnostics based on polymerase chain reaction (PCR) and next-generation sequencing (NGS) 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. As with all diagnostic assays, the performance of novel technologies used to assess health at the cellular and molecular level must be validated as required for regulatory approval and commercial success. Development and manufacturing of these disruptive technologies into validated IVD assays can, however, require strategies and resources that differ from those needed for traditional approaches.

This application note from Millipore Sigma highlights key considerations for emerging and established companies as they advance novel molecular diagnostics from the bench to commercial production and distribution and how a contract manufacturing partner can help.

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