Icosagen In The News

FITkit® technology has become an international standard

ASTM International (www.astm.org) adopted a new standard "Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins in Natural Rubber and Products Derived from Latex" that bases that bases on Icosagen’s FITk® technology.

The significant efforts made by Estonian biotechnology company Icosagen AS (formerly Quattromed AS) towards developing a new ASTM standard have been successful. In June 2008, ASTM International adopted the new ASTM standard D7247 (Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Products Derived from Latex). Since September 22nd, 2008 it is available to everybody via the ASTM homepage (www.astm.org). The current standard is based on Icosagen’s FITkit® technology. 

FITkit® technology is the first-ever test for the quantification of clinically relevant NRL allergens from rubber products. Other methods available provide detection of the total content of proteins or the semi quantitative measurement of immunogens in the sample product. Because there is no direct relationship between protein content, immunogenicity of proteins and the allergenicity of latex proteins, the latex industry and users of latex products suffer from an under- or overestimation of the allergenicity of NRL products. Compared to previous methods, FITkit® measures only those proteins that are allergens. Furthermore, it quantifies those allergens that are responsible for the majority of sensitivity or allergy cases. FITkit® tests are based on a sandwich ELISA (Enzyme Linked Immunosorbent Assay) technique.

“Now we can proceed with ASTM glove standards that must be updated using the new test method,” commented Chairman of the Board Professor Mart Ustav on the news. “Obviously, it won't be any easier than the first step. Regardless of the serious work that needs to be done, FITkit® technology, together with the recently published allergenicity classification, gives industry a clear way to overcome latex allergy concerns. Furthermore, if all NRL products were to pass accurate testing and belong to a safer category, NRL would no longer pose a serious risk to health. Therefore, there is no doubt that we have a positive agenda to proceed with,” said Professor Ustav.

Icosagen AS is focused on the allergenicity testing (FITkit®) of natural rubber latex materials and on the development, production and sales of life science products. The management system of Quattromed AS complies with the requirements of the ISO 9001:2000 standard.

For further information please contact: 
Hardi Tamm
Sales and Marketing Manager
Tel. +372 737 7070
Email: hardi.tamm[at]icosagen.com