Biofortuna is a leading diagnostics company offering both custom IVD development & manufacturing services and molecular diagnostic products. Being ISO13485 certified and FDA registered, we are your partner of choice for IVD immunoassay and molecular diagnostic development & manufacture. We also specialise in freeze-drying diagnostic products enabling complete PCR reactions and immunoassay reagents to be transformed into stable pellets.

Using proprietary freeze drying technology, expertise and experience, we can lyophilise your complete PCR reactions and immunoassay reagents, to be stable at ambient temperatures.

We offer IA development and a complete ELISA plate coating, vialling and kitting manufacturing service within our ISO13485 certified and FDA registered site.

Biofortuna offers a range of freeze dried, CE marked and FDA approved PCR kits, for the HLA disease association market. These kits only require the end user to add DNA prior to amplification and detection, offering unique simplicity, accuracy and ease of use.