An interesting 'big picture' news article from Biopharma...
In Vitro Diagnostics (IVD) Market Size to Surpass USD 157.56 Billion by 2034 - BioSpace.pdf
Lab Developed Tests, otherwise known as In-House Tests, are IVD tests endorsed by a particular lab without the need for costly and lengthy FDA or TGA, or equivalent approval. This type of commercial pathway specifically exists so innovative tests, such as Colostat, can be utilised sooner to benefit patients without heavy approval cost burdens. The pathway also allows for data collection along the way to be used for potential future FDA/TGA approval.
Not surprisingly, there is continuing massive growth in Contract Manufacturing Labs because their inclusion in the process facilitates the increasing demand for rapid scientific developments in healthcare, such as Colostat!
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In Vitro Diagnostics (IVD) Market Size to Surpass USD 157.56 Billion by 2034
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