SPECIALfinder GENERON. Food Allergens Detection Solutions. Food Safety in our Genes

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1 SPECIALfinder Food Allergens Detection Solutions GENERON Food Safety in our Genes

2 Values to rely on GENERON assays feed your safety and quality assurance through our best direct technical support. Generon is a young, expanding company specialized in the production and distribution of test solutions for the food and feed industries. Generon biotechnology labs are located in Modena, in the heart of Italian Food Valley, once known as the breadbasket of the Roman Empire. As food safety specialist Generon creates and select sharp, cost effective and efficient test kits to provide an ever increasingly demanding market with accurate and ready-to-use solutions and meet customers needs. At Generon we mostly aim to select and offer best-in-range and easy to use assays along with an effective, specific and just-in-time technical support. Behind every Generon product is the expertise of a dedicated professional team: biologists, chemists, food technologists, customer service and sales specialists all connected and committed to boost customers quality control diagnostics through profitable partnership. Thanks to our organizational capabilities and speed of response we have been able to achieve exceptional results placing us amongst the top players in the market. Even though ever more challenging, future offers exciting prospects and we remain high-reaching, willing to get further and to become the leading benchmark in the food & feed safety field.

3 Contents Allergens Detection Molecular Methods Real-Time PCR Generon Products ION-Force SPECIALfinder PCR-based Portfolio

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5 Allergens Detection Molecular Methods Real-Time PCR

6 Food allergens control needs SPECIAL care In a globalized food market with increasing demand for quality and safety monitoring, there is a need for streamlined testing solutions that are sensitive, accurate, and easy to use with a variety of starting materials. Allergens are becoming an increasingly important issue for food safety. The presence of hidden allergens may be due to two main reasons: the use of processing lines for multiple products during manufacturing and packaging; the use of proprietary ingredients that where derived from allergenic raw materials (starches, texturants ).

7 Food allergen detection needs SPECIAL methods Allergens contamination may be revealed through the specific detection either of the allergen itself or of a marker (specific proteins and/or DNA fragments of the allergenic ingredient) indicating the potential presence of the allergen. Ultimately, the agent causing an allergic reaction is a protein. In the past, this raised the question whether basing allergen testing on molecular methods that screen for DNA is appropriate. There is nowadays a widespread consensus on the importance of an integrated approach and there are also evidences for a correlation between allergen quantification based on the direct detection of allergen proteins versus the detection of allergen via DNA.

8 A Molecular Method Real-Time PCR Real-Time polymerase chain reaction (PCR) is the goldstandard for the detection of DNA of contaminating allergens. This technology enables a very specific, highly sensitive and, in combination with a suitable reference material, even quantitative detection of food allergens. Real-Time PCR can detect all allergens except those milk and egg-derived (low DNA content) as well as sulfite and histamine (chemical parameters). Since DNA is a very stable molecule, PCR can be applied also in highly processed food matrices. Sample preparation is identical for all parameters enabling time and cost saving workflows. Real-time PCR is therefore gaining importance to detect food allergens as a complementary/alternative tool to established ELISA-based assays prevalent in the food testing sector.

9 Real-Time PCR offers a highly standardized allergens testing method that enables true comparison of results across different food types, allergen types, and testing laboratories. The reasons for this standardization are: Specificity PCR primers and probes react only when bound to specific DNA sequences. The possibility of false positive from aspecific binding due to sticky compound is almost null. Resistance When DNA is properly purified the workflow is not affected by interfering chemicals present in food matrices. Heat Stability Unlike protein-based assays, DNA detection is not susceptible to molecular modification caused by food processing. Selectivity In contrast to ELISA, Real-Time PCR enables differentiation of closely-related species with no cross-reactivity and in the case of celery it is the only method of detection. Control Real-Time PCR approach enables a number of process controls that enhance overall process safety.

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11 Generon Products ION-Force SPECIALfinder PCR-based Portfolio

12 Generon SPECIAL solutions DNA is a very stable molecule being almost unaffected by food processing whereas proteins are easily denatured hampering the detection through antibody based techniques. SPECIALfinder Real-Time PCR Assays detect DNA sequences indicative of the presence of allergenic species.the technique offers a high degree of detection specificity and differentiates closely-related species. DNA extraction and purification are critical steps in a PCR experiment as the efficiency and sensitivity of a PCR depend on the purity and yield of the extracted DNA. These parameters are deeply impacted by the matrix. Complementing SPECIALfinder detection assays, Generon offers ION- Force Fast DNA Extractor, a sample preparation kit specifically designed to process a variety of food materials, providing an optimal workflow performance.

13 Why choose Generon products

14 ION-Force Ion-Force Fast DNA Extractor is a kit planned to be universal, simplified, and rapid, maximizing the yield and purity of the DNA extracted from different samples either raw or processed. It is an essential system to obtain repeatable and reproducible data from downstream Real-Time PCR analysis. ION-Force Extraction Protocol The non-ionic detergent CTAB is widely used and is world-wide recognized as a benchmark for efficient extraction of total cellular nucleic acids from a wide range of tissue types. It is a CTAB-based extraction method but compared to conventional, labor-intensive traditional CTAB extraction protocols, the protocol of ION-Force DNA Extractor is significantly faster, accomplishing up to 30 extractions in 2.5 hours. The DNA extracted is of equal quality and purity as that obtained with conventional CTAB protocols and results are more reproducible. ION-Force Workflow

15 4 good reasons to choose ION-Force 1-4-ALL APPROACH FRAGMENTED DNA RECOVERY It allows extraction from both vegetal or animal matrices using the same kit. Specific protocols were developed to extract DNA from high viscosity samples, liquid samples, pasty fluid samples, solid samples in less then 90 Minutes. It allows to extract short DNA fragments (down to 100 bp) from processed matrices subjected to heat, irradiation, high pressure, and changes in ph which lead to DNA degradation and fragmentation. SCALABLE PROTOCOL PROGRESSIVE CLEAN-UP It allows extractions from large and representative sampling units (up to 20 g of sample) with proven efficiency on food, feed, fecal samples and other biological matrices. It allows removal of PCR inhibitors from complex matrices generating optimal and reliable results even where the other available commercial kits are not able to perform. These features make extraction with ION-Force Fast DNA Extractor a universally applicable method that generates optimal and reliable results even when extracting DNA from strongly inhibitory, highly processed, fatty, acidic, or low-dna containing food. ION-Force Fast DNA Extractor is successful where the other available commercial kits are not able to perform. That s why it is the method of choice at the NRL for GMO analysis in Rome (Italy).

16 SPECIALfinder SPECIALfinder is the portfolio of products for the DNA based detection of allergens developed by Generon, a turn-key solution for demanding clients willing to perform allergens control with a high level of accuracy and confidence. SPECIALfinder Assays Tests developed and validated according to UNI-EN : 2009 guidelines to detect the target allergen DNA with high specificity and sensitivity. Absence of cross-reactivity was tested towards a large number of food ingredients to avoid false positives. All the tests are made using prime-quality molecular biology grade reagents. SPECIALfinder DigiCount Total DNA extracted from allergens using Generon ION-Force Fast DNA Extractor with SPECIALfinder Assays target sequences content quantified using Droplet Digital PCR technology. SPECIALfinder SpyX Powdered allergens dispersed in corn flour at 500 ppm that can be used as analytical process and extraction controls with both molecular and immunochemical methods.

17 Method in 4 steps Collect sample DNA extraction from sample ION-Force SPECIALfinder SpyX DNA amplification SPECIALfinder Assays SPECIALfinder Digicount DNA results

18 Generon portfolio a further look Nucleic acids based analysis methods and their standardization are the core of Generon R&D and sales activities. In addition to the product line designed for Allergens detection, Generon offers many other Nucleic Acid Amplification based Kits. Generon portfolio includes the following product lines: SPECIALfinder For the detection of allergen proteins. MODIfinder For the screening, identification and quantification of a wide selection of GMO events according to EU norms. VERYfinder For assessing ingredients authenticity (e.g. meat species ID) using Real-Time PCR and Digital PCR. PATHfinder For detecting the presence of a wide range of pathogenic or spoilage microorganisms. WHATfinder For the detection of the most important foodborne and waterborne viruses. VETfinder Solutions for diverse veterinary applications.

19 Disclaimer Please check with your agent before making a final purchase decision based on the Information here displayed. While every care is taken to insure that the information in these pages is correct it may be subject to technical inaccuracies or typographical errors, may vary from territory to territory and is subject to change without notice. Generon srl

20 Contact us: Via San Geminiano, San Prospero (MO) - Italy marketing@generon.it