Our project proposes the replacement of Formalin with GAF, a non-toxic and non-cancerogenic fixative solution, with equivalent (if not better) histological efficacy, responding to the need to protect the health of workers involved and, at the same time, the health of patients.
Furthermore, the project is aimed at protecting the environment by reducing the use and disposal of a toxic product such as Formaldehyde. In fact, Formaldehyde’s carcinogenic and toxic vapours absorbed by the hoods are partially released into air, while the disposal of liquid Formalin is complex and expensive. It is desirable that the amount of toxic waste released in the environment, although somehow controlled, be strongly reduced.
Therefore, the replacement of Formalin is recommended for both environmental and health reasons. Furthermore, they are now normatively mandated by EU legislation. Glyoxal (a di-aldehyde similar to Formaldehyde) is not volatile nor toxic. When deprived of troublesome acids, Glyoxal Acid-Free (GAF) represents a safe histological fixative and a Formalin alternative, providing results as good (or even better) than Formalin. This has been proved by histological, immuno-histochemical and molecular analyses.
Tissue fixation, leading to preservation of structural components by fixation and permeabilization of cells and tissues, plays a critical role in histopathological diagnosis.
The fixative of choice is still represented by Formalin (a water solution of Formaldehyde).
This reagent is toxic and cancerogenic, but is still used worldwide in the lack of alternative fixative solutions guaranteeing similar results.
GAF (Glyoxal, acid free) fixative solution is an innovative reagent that allows optimal tissue fixation at the structural and molecular level, combined with the absence of toxicity and carcinogenic activity.
The validation of GAF fixative, as compared to Formalin, was conducted on parallel samples, obtained with core needles or punch devices from surgical specimens and fixed alternatively in Formalin and in GAF.
The first Validation trial was conducted in December 2017 at the San Giovanni Battista Hospital of Turin.
Validation of GAF fixative, as compared to Formalin, is conducted through national and international Trials evaluating results of parallel samples, obtained from surgical specimens, fixed alternatively in Formalin and in GAF. The first Validation trial was conducted at the San Giovanni Battista Hospital of Turin, Italy. The results confirmed the feasibility and validity of GAF fixation as alternative to Formalin fixation.
Representative slides (10 cases in parallel, fixed either in Formalin or in GAF) of this first Trial are shown below.
The research and technology transfer activities have been the subject of in-depth articles available here:
ADDAX Biosciences was born as a spin off of the University of Turin, which contribuited with support to the research activity.
Our company has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement No 8157692.
The project “GAF – Towards a hospital without Formalin” is realized thanks to the co-financing of POR FESR Piemonte 2014-2020, Ob.1 – “Research, technological development and innovation, I.1.b.4.1 “Support for creation and consolidation of innovative start-ups with a high intensity of application and knowledge and research spin-off initiatives”.
The project aims to validate, produce and market GAF, a histological fixative without carcinogenicity, that works as a substitute to Formalin. Achieving the project’s objectives will improve the working conditions of health and research professionals, protecting them from the risk of developing occupational diseases caused by inhaling Formalin vapours.