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European Court of Justice Ruling on Genome Editing: Recently, under the EU regulation on genetically modified organisms the judgment is passed through the European Court of Justice that gene-edited crops should be subjected to the same stringent regulations as conventional genetically modified (GM) organisms. In turn, the trial releases of plants and animals obtained by genome editing will also be subjected to the requirements of risk assessment and authorization. The EU Directive on the deliberate release into the environment of genetically modified organisms of 2001 (Directive 2001/18/EC), established a stringent system of control over the release and marketing of GMOs. According to Article 2(2), a GMO is an organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.
In this closely watched decision, the court ruled that plants that are created with new gene-editing techniques, which do not involve transferring genes between organisms such as CRISPR, subjected to go through the same lengthy approval process as traditional transgenic plants. This regulatory process typically costs about $35 million. On the other hand, the French government passed a law to release these new gene-edited crops from regulation under the European Union’s directive on genetically modified organisms (GMOs), which requires an assessment of risks to health and the environment, as well as labeling, tracking, and monitoring of the products. In addition, a French union in Bagnolet, Confédération Paysanne that represents small farms and eight other groups, sued and charged the plants modified with gene-editing techniques that it should be regulated under the GMO directive.
The products obtained by genome editing are also subjected to labelling requirements. On the other hand, small seed producers, including biotechnological start-up enterprises will expected to face difficulties in the coming years. The judgment can hamper the biotechnological research in Europe and it is going to impact plant breeding in Europe hugely and negatively.
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Rise in the Advancements for Genome Editing Technologies: The biotechnological field is characterized as a continuously developing the technologies for the betterment of the health for all the living organisms. Therefore, the technologies for the genome editing is undergoing various advancements, the most recent advancement for the genome editing is utilizing the nucleases which include the zinc finger nuclease (ZFN), transcription activators like effector nuclease (TALEN) and (clustered regulatory interspaced short palindromic repeats) CRISPR Cas9 system. The technologies has been successfully implemented in the several crops, including the Solanaceae plants, such as tomato, potato, tobacco, and petunia. CRISPR Case 9 among the three nucleases is the best for breeding, crop improvement, and the functional analysis of genes of interest. The technology is best due to its simplicity and high efficiency.
The technological advancements are being carried out by most of the biotechnological companies. The companies are continuously involved in the research and development for the technologies and producing the products for the genome editing. In addition, most of the start-up companies are involved in the development of the genome editing tools and services. For instance, UK based company, Horizon Discovery have discovered cell lines, the company has utilized the ability of the rAAV’s to amplify the cell’s own high fidelity DNA repair pathway. The cell lines created consists of the precisely engineered, disease that are associated with mutations for the most widely studied oncology genes, such as KRAS, PIK3CA and BRAF. Moreover, the company is also license out its nuclease-based genome editing technologies to improve our efficiencies still further at first Zinc Finger Nucleases (ZFNs), and then CRISPR Cas9 gene editing. Thus, the technological advancement for genome editing tools by the market players and the start-up companies are likely to drive the market for the genome editing market in the forecast period.
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