Focus Area: Biotechnology

• International Day of Awareness of Food Loss and Waste – An urgent need to safeguard climate and food security

  September 29, 2023 4:00 am Comments Off on International Day of Awareness of Food Loss and Waste – An urgent need to safeguard climate and food security

  Australia’s agricultural sector provides an estimated 75 million people, both at home and abroad, with safe, nutritious, high-quality foods. In addition to providing food, our sustainable and resilient farming sector, bolstered by ground-breaking agricultural innovations, is a major driver of economic growth for Australia. Concerningly, the impact of climate change and the increasing frequency of natural disasters on crop loss is increasingly a major threat to the future of our food security globally.

  “It is serendipitous that International Day of Awareness of Food Loss and Waste lands on the same week as Australia’s first National Disaster Preparedness Summit,” said Matthew Cossey, Chief Executive Officer of CropLife Australia, the national peak industry organisation for the plant science sector.

  “Ensuring effective natural disaster responses and recovery resources are available to support the vital farming sector that bears the brunt of many of these shocks that destroy our crops is crucial.

  “Pests, weeds and diseases continue to be major threats to the production, profitability and sustainability of Australia’s farming sector, leading to food loss. This is only increasing with climate change and the rising incidence of natural disasters,” said Mr Cossey.

  “Weeds, insect pests and diseases can destroy a crop, either by eating it before it can be harvested, or by pathogen infection which renders the crop unpalatable or unsafe for eating. These pests don’t stop at the farm gate; they continue causing damage through transport and storage, all the way to consumers’ homes.

  “Australians are already highly sensitive to the true value of food as cost-of-living pressures rise, and even small fluctuations in food production and food losses cost lives globally,” said Mr Cossey.

  The plant science industry continues to invest billions of dollars in R&D to further assist farmers minimise crop losses. Herbicides, fungicides and insecticides continue to provide Australia and the world’s crops with vital protection against insects, diseases and weeds during production and harvest. In Australia alone, without farmers access and use of modern crop protection products, almost three-quarters of the value of the food produced would vanish, resulting in a range of fresh produce essentially disappearing from Australian shelves.

  Biotech crops help to prevent pre-harvest losses by protecting against threats such as plant diseases and pests like insects, which can cost farmers a devastating 60-80 per cent of their yield in some developing regions.

  Pest resistant GM crops have been shown to increase average yields by 22 per cent, and farmer profits by 68 per cent, which creates profound, life-changing opportunities for subsistence farmers to escape from poverty.

  Mr Cossey continued, “At the other end of the spectrum, nearly 1.3 billion tonnes of food is wasted globally each year as 800 million people in the world go hungry. Food waste contributes to about eight per cent of global greenhouse gas emissions and can cause as much damage to our planet as plastic waste.

  “Governments around the world including Australia are tackling the issue of food waste through the UN Sustainable Development Goal of halving food waste by 2030. These efforts have a strong ally in the plant science industry. A great example is Arctic Apples. Developed using CSIRO technology by a Canadian company and now released in the US, these gene-edited apples essentially eliminate browning and are therefore less likely to be thrown away, significantly cutting food waste.

  “This is just the beginning. Governments, farmers and the entire food value chain must work together and support sustainable agricultural practices that utilise plant science innovations like pesticides and GM crops. By doing so, we can tackle food loss and waste and climate change, while ensuring a more secure future for our global food supply during these challenging times,” concluded Mr Cossey.

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• A genes difference in sorghum digestibility

  March 31, 2022 4:58 pm Comments Off on A genes difference in sorghum digestibility

  Sorghum is the third largest crop in Australia. Now biotechnology is helping to realise its full nutrition potential.

  The ancient grain sorghum is Australia’s third largest crop and a staple food for animals and more than 500 million people worldwide. However, the proteins in sorghum are not easily digested by humans or animals, making it less nutritionally and economically valuable than wheat or maize. Now biotechnology is helping to realise its full nutrition potential.

  Researchers from the University of Queensland have used gene-editing to increase the protein content and digestibility of new sorghum lines. The last review of the Gene Technology Regulations has enabled the new sorghum lines to be sown in the same way as plants produced via conventional breeding. This discovery has important potential for the poultry, pig and beef feedlot industries with more protein efficient feed, thereby delivering benefits to the Australian consumer.

   

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• Future-proofing biotechnology innovation

  4:57 pm Comments Off on Future-proofing biotechnology innovation

  With biotechnology making huge leaps in the areas of agricultural and medical research, the regulatory system must keep pace. The modernisation of Australia’s National Gene Technology Scheme will be essential to the development of new technologies, well beyond plant science.

  Australia has long been at the forefront of the regulation and adoption of biotechnology innovation. Gene editing has developed new and improved crop varieties, helping farmers respond to ever-changing climate conditions and consumer demand. But the potential benefit of biotechnology extends well beyond agriculture.

  There have been many major advances in biotechnology and medicine even before COVID-19 appeared. But the pandemic has put the sector ‘centre stage’ and revolutionised the development of new vaccines which has quite literally saved lives.

  As science and technology evolves, so too must the legislation that enables it.

  CropLife Australia has worked hard with governments to propose practical and feasible regulatory options supported by academia, the public research sector and industry including plant science, human health and animal research.

  What the sector needs and is looking for are simple, logical and feasible improvements that would have a tremendously positive impact on Australian agriculture and medical research and align Australia with key international competitors such as Canada, the US and South America.

  A considered, agile, future-proofed system will allow innovation to flourish and the benefits flow through to the Australian economy. To further delay modernisation of the national framework would inhibit innovation, leaving Australia behind for decades to come and drive developers to stronger markets.

  The opportunities to improve the lives of all Australians through biotechnology are endless. It is up to policymakers to give innovators the regulatory landscape they need to achieve a better, brighter, more sustainable future. A considered, agile, future-proofed system will allow innovation to flourish and the benefits flow through to the Australian economy.

   

  Read the full CropLinks edition.

• Case Study – Heart-healthy Tomatoes, Japan

  September 15, 2021 12:19 pm Comments Off on Case Study – Heart-healthy Tomatoes, Japan

  Introduction

  Gene-editing techniques enable the production of plants with improved traits, such as resilience to environmental stress and pest pressure or greater yields and food products with extend shelf-life and enhanced nutritional properties. These and other applications also contribute to environmental management and industrial processing to offset pollution and create products such as biofuels.

  Conventional plant breeding processes are extremely time and resource-intensive due to long breeding cycles and time taken to reproduce desired traits. This breeding takes many years and a lot of research funding to accomplish, and represents a significant issue given the ever present need to address issues associated with climate change and food security.

  Gene-editing is a promising tool as it speeds up the breeding process by allowing plant breeders to target and adjust specific DNA sequences and achieve desired traits immediately. It is just one example of the kind of new breeding techniques (NBTs) that are needed to speed up the breeding process by improving precision and efficiency, and solve some of the world’s most pressing health, environmental and food production issues.

  Australia’s current regulations are unclear and act as a deterrent to critical investment in research, development and the ability to commercialise products from techniques such as gene-editing. This has a global impact by limiting access to and the application of these agronomically, environmental, and socially valuable technologies.

  Gene editing in global policy

  Biotechnology continues to gain momentum as a major focus for the world’s policy makers. Over the past four years, several countries including Argentina, Brazil, Chile, Colombia, Israel Paraguay and the US, have clarified the regulatory status of gene-edited crops and their products, with those that do not incorporate foreign DNA currently regulated as conventional plants with no additional restrictions.

  More recently, some of Australia’s major trading partners, such as China, and competitor nations, including Russia and Canada, have also indicated interest in considering policy changes related to gene editing and products derived from NBTs.

  For plant breeders and technology developers, research and development (R&D) of NBTs with agricultural applications is possible but for the most part, economically unfeasible. The primary constraint for the R&D and commercialisation of products from these techniques is the regulatory and cost hurdles associated with assessment and registration processes.

  Gene technology regulations should promote innovation and industry growth and ensure Australia’s farmers have access to safe, innovative, modern agricultural tools to support the production of safe and nutritious food, feed and fibre, and environmental sustainability.

  Case Study – Heart-healthy Tomatoes, Japan

  In late 2020, Japanese start-up, Sanatech Seed, was granted approval by Japanese regulators for the commercial release of a new tomato variety with enhanced nutritional properties. The tomato was gene-edited to increase the accumulation of the naturally occurring amino acid, Hamma-AminoButryric Acid (GABA), which promotes health and has nutritional benefits for treating metabolic disorders and reducing blood pressure and stress. GABA is also involved in stress-tolerance and is reported to be highly involved in plant-pest interactions, meaning it also has production benefits for farmers and home-gardeners.

  The improved variety, called ‘Sicilian Rouge High GABA’, was produced from the ‘Sicilian Rouge’, a conventionally bred variety already popular with Japanese consumers.

  Set for release in May 2021, the Sicilian Rouge High GABA tomato will be the world’s first direct consumption gene-edited tomato and is reported to be the first of several other new varieties under development with enhanced nutritional benefits. It will initially be available for free to 5,000 home-gardeners who subscribed to take part in the pilot program. A complimentary education program with consumers and the community will also be rolled out prior to the major commercial release which is expected in 2022.

  Widespread government-led marketing campaigns in Japan to educate consumers about the difference between genetically modified organisms (GMOs) and gene-edited crops, means that there is a higher level of understanding and acceptance of these products than in other parts of the world. This means strong consumer acceptance is predicted however, the start-up will closely monitor consumer sentiment and satisfaction with the tomatoes prior to major commercial release.

  The Sicilian Rouge High GABA tomato took over 15 years to produce, with more rapid advances only occurring following the development of CRISPR/Cas9 in 2012. Commercialisation was only viable because in 2019 Japanese regulators removed unnecessary regulations and provided clarity on gene-edited plants and their products where they are developed comparably to natural processes of genetic mutation.

  Similar to the US, Japan has voluntary labelling requirements for gene-edited foods and the Sicilian Rouge High GABA tomato seedlings and fruit will reportedly be voluntarily labelled by Sanatech Seed and participating growers as being produced with gene editing technology to promote transparency and consumer choice.

  The approval of this tomato is a huge step forward for plant science in Japan and promotes ongoing R&D and development of improved processes and products that not only add to the suite of tools available to growers for sustainable production but enhance consumer choice and access to nutritious produce.

   

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• Case Study – Gene Editing: The Last Hope for Bananas

  12:13 pm Comments Off on Case Study – Gene Editing: The Last Hope for Bananas

  Introduction

  Australia’s gene technology regulatory systems need to be modern, appropriate, consistent, and flexible to respond to scientific advances in a timely manner. Undue regulatory burden in pre-market regulation of products developed using new breeding techniques, disproportionate regulation of certain gene editing approaches; and lack of clarity and clear path to market needs to be removed to truly harness the benefits these technologies pose.

  Biotechnology offers innovative technologies and applications in many key sectors including agriculture and environmental protection, human health, and food and nutritional security. Crop biotechnology specifically provides technically and commercially viable solutions to mitigate the challenges of food and nutritional security. With a burgeoning population which is expected to increase to 8.6 billion by 2030, biotechnology innovations will contribute significantly towards achieving the 2030 Sustainable Development Goals (SDGs).

  Case study – Gene editing: The last hope for bananas, worldwide

  There are more than 1,000 banana varieties globally. Cavendish bananas make up around 97 per cent of the domestic banana market in Australia and about 50 per cent of all global banana production.

  What makes the Cavendish banana so special is that it is a genetic outlier among crops because it has three sets of chromosomes, rather than two. This renders the Cavendish banana sterile and only able reproduce from new shoots that grow into little plants (genetically identical to the parent plant) that are removed and propagated[1].

  Since all Cavendish bananas are essentially identical in terms of genetics, this makes it the ideal variety to grow at scale due to predictability in agronomic management, consistent yield and fruit quality, ripening and shelf life. As well as being a highly nutritious fruit, these qualities also allow the bananas to be sold at low cost, making them even more favourable among consumers.

  This socially and economically important food crop is facing unprecedented challenges due to its susceptibility to the soil-borne fungus Fusarium wilt tropical race 4 (TR4), also known as Panama disease. TR4 affects nearly all banana varieties. It can remain in the soil for over 40 years and there is no effective control for it. Due to the low fertility and long generation times of conventional breeding with bananas, exploitation of resistance genes that have been identified in banana species with two sets of chromosomes[2] has been slow. Gene editing offers a very promising alternative strategy for the improvement of commercial TR4 banana varieties.

  Panama disease has devastated Cavendish plantations in many parts of the world and is spreading rapidly across Asia. The disease poses a serious threat to global banana production, including in Australia where Far North Queensland grows 95 per cent of all of Australia’s bananas. In communities like these, the banana industry is crucial to jobs, income and quality of life.

  In 2017, Distinguished Professor James Dale and the team at Queensland University of Technology (QUT) revealed they had developed and grown genetically modified (GM) Cavendish bananas resistant to TR4. The development of the TR4 resistant line then led to a partnership with US-based international fresh fruit and vegetable leader, Fresh Del Monte, which has enabled the researchers to use the gene editing tool CRISPR to develop a non-genetically modified variety of Cavendish that will also be resistant to TR4. The crop is currently in the sixth year of field trials in the Northern Territory.

  Professor James Dale has also pioneered GM biofortified bananas, enriching East African bananas in Uganda with pro-vitamin A.  This enriched banana can significantly improve nutrition and prevent vitamin deficiency which leads to an estimated 670,000 deaths of children in developing countries and blindness in another 400,000 every year. The bananas are currently in field trials in Uganda, where the fruit is the major staple food in daily diet. The bananas were expected to be released for use for farmers in 2021, but unfortunately the impacts of COVID-19 will likely delay their release.

  Professor James Dale said that major banana producers of the world have already decided that the future of bananas is gene editing. Further to enhanced nutrition and disease resistance, gene editing will also allow producers to focus on consumer traits (think things like the Pinkglow™ Pineapple), boutique varieties and improved fruit quality. Rather than focusing on developing new varieties, gene editing will allow us to improve the 1000 plus other great banana varieties that currently don’t make it to market because they suffer from low yield, poor fruit quality and disease susceptibility.

  Professor Dale believes Australia has the opportunity to be a leader in banana development. Banana breeding in Australia has been ongoing for around 50 years and yet there has still not been a successfully bred variety. While conventional programs are getting better, they are time and highly resource intensive. On a global scale Australia is only a small market and so we need modern and appropriate regulations to keep pace. Without that there is a risk producers will take this technology to countries like Canada and the US where gene technology regulations are risk-based, proportionate and provide a clear path from conception to consumer.

  [1] Triploid bananas have three sets of chromosomes and therefore cannot pair up into even numbered groups – this makes them sterile and most sterile plants produce no seeds. Banana fruit from triploid varieties, like Cavendish, is therefore seedless.

  [2] Diploid bananas have two sets of chromosomes, one from each parent (like humans).

   

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• Case Study – Gene Editing: Individualised Treatment for Patients

  12:06 pm Comments Off on Case Study – Gene Editing: Individualised Treatment for Patients

  Introduction

  In addition to agricultural, environmental and industrial application, gene editing techniques present substantial possibilities in medicine and healthcare for the diagnosis, treatment and prevention of serious illness and disease.

  Refinement of these techniques and subsequent development of safe and effective products for these purposes, in many cases, has been underway for several decades. Recent examples include mRNA vaccines, as well as treatments for sickle cell disease, muscular dystrophy, HIV and other conditions.

  While progress in addressing other conditions that have previously been out of reach has been made, unnecessary regulatory barriers continue to hinder the research and development needed to substantiate safe and effective medicines and accelerate processes from development to clinical trials.

  Under existing regulatory conditions and provisions of the National Gene Technology Scheme and associated legislation, SDN-2 and Oligo-Directed Mutagenesis (ODM) gene editing techniques are regulated as conventional genetic modification, despite some of the resulting products being indistinguishable from those developed through conventional processes.

  Some applications of SDN-2 and ODM use site-specific guides and repair templates that allow for highly specified changes and predictable outcomes in comparison to randomly induced mutations when using SDN-1 techniques. This increased specificity not only accelerates product development, but it also allows for greater predictability and increased success of the desired alteration.

  Continuing to regulate these techniques and their products as genetic modification will hamper the development of critical technologies in medicine and healthcare sectors, like affordable diagnosis and treatment options to address serious health issues.

  Gene technology techniques such as SDN-2 and ODM which have a history of safe use should be excluded from regulation. This can be achieved as part of the current review of the Scheme by linking to changes in definitions. This would ensure the Scheme remains relevant and would pave the way for a more proportionate regulatory system. It would eliminate the need for further, unnecessary and lengthy steps of regulatory reform and would ensure better access for researchers and developers to the full range of tools needed to support Australian innovation.

  Australia needs a National Gene Technology Scheme that encourages and supports agricultural, medical, and pharmaceutical research and enables innovation. This will increase and improve Australian food security, health, wellbeing, and economic performances. This can only be achieved if biotechnology techniques are regulated in a proportionate, science-based manner.

  Case Study – Individualised treatment for cancer patients

  In early 2020, the Therapeutic Goods Administration (TGA) of Australia approved a new cancer treatment known as CAR T-cell therapy, via the product Kymriah® (tisagenlecleucel), for the treatment of leukaemia and lymphoma in patients where alternative treatment options have been exhausted.

  CAR T-Cell therapy is a once-off, individualised treatment that uses gene editing techniques beyond the capability of SDN-1 to reprogram the patient’s own T-Cells to fight cancer. It is primarily used to treat blood cancers; however clinical trials are underway to also apply CAR T-Cell therapies to solid tumours.

  Prior to approval, Australians receiving immunotherapy were required to have blood collected and sent overseas to undergo the reprogramming process before the cells could be returned and used for treatment.

  Domestic regulatory approval removed a major bottleneck of international processing and transport. Enabling Australia’s first onshore commercial manufacture of the therapy substantially reduced patient treatment time, from blood collection to infusion. Government approval also led to subsidised access to the treatment, providing eligible patients with new hope and the prospect for improved quality of life and even a cure for their life-threatening illness.

  Therapeutic products like Kymriah® can be life-changing for patients and their loved ones. In addition to the direct medical benefits, the success of these developments attracts vital funding for health and medical research for discoveries that will drive future innovation. This also contributes more broadly to Australia’s health and economic future by improving public health and quality of life, maintaining a strong workforce and reducing the cost of health care through improved techniques and technology. These improvements could subsequently lead to savings in the health budget. Definitions of medical research, health practice activities and use of data for these programs according to current regulations, however, can become complex and limit prospects of important medical research.

  Due to this approval, institutions such as the Peter MacCallum Cancer Centre can continue to explore the technology and expand possibilities for the treatment of other cancers. This in turn can lead to clinical trials and the potential commercialisation of products to improve health outcomes and improve the lives of patients suffering from chronic and critical illnesses.

  CAR T-cell therapy is just one application of gene editing in medicine that has the potential to improve patients’ lives. It is just one example of the positive impact appropriate regulation can have for patients and for the Australian community more broadly. More needs to be done to ensure Australian and global communities can access the lifechanging products of gene editing by supporting technology providers to move beyond proof of concept, to clinical trials of safe and effective novel treatment solutions.

   

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• Today marks major ag innovation milestone with farmers in all mainland Australian states now free to grow GM crops

  July 1, 2021 5:00 am Comments Off on Today marks major ag innovation milestone with farmers in all mainland Australian states now free to grow GM crops

  1 July 2021 marks the expiry of the NSW GM crop moratorium, meaning every mainland state can now access all approved GM crops. This brings Australia’s farmers into line with their major international agricultural competitors and underpins a great productivity and environmental sustainability leap for Australian farming.

  Chief Executive Officer of CropLife Australia, the national peak industry organisation for the plant science sector, Mr Matthew Cossey, said, “Today is a huge leap forward for innovative, modern and sustainable agriculture. With the NSW moratorium expiring today, state governments across mainland Australia have now all made decisions in the best interest of their farmers by allowing them access to all GM cropping innovations approved by the Federal Gene Technology Regulator.

  “Farmers should be the ones to make their own choices about what crops to grow that best fit their farming environment and business model. Having access to GM crops is only going to become more important as farmers continue to face periods of drought and increasingly harsher conditions in a changing climate.

  “Recent crises, including the COVID-19 pandemic, have not only highlighted the value of technological advances – such as those that facilitated the rapid development and public access to vaccines – but also the importance of the regulatory framework being prepared, responsive and fit-for-purpose under these circumstances. The importance of food security highlighted by the pandemic is a prime example of the continuous need for exploration and development of agricultural innovations via both conventional systems and modern approaches, such as genetic modification, gene editing and in chemical and biological crop protection.

  “The global pandemic caused the single greatest disruption to global food supply in generations. Throughout, the Australian agriculture sector has delivered continuity in supply of safe and nutritious food, feed and fibre to domestic and global markets. All this while managing the challenges associated with access to critical farm inputs, supply chain services, an agricultural workforce and border restrictions. Safe and effective biotechnology and crop protection innovations will play an increasing role in meeting and mitigating food production and supply challenges.

  “A major strength of biotechnology is that it does so much more than boost agricultural yields. Biotechnology has strong environmental and industrial credentials and presents substantial possibilities in medicine and healthcare for the diagnosis, treatment and prevention of serious illness and disease.

  “With all mainland Australian state moratoria removed, we will see stronger research and innovation which will facilitate access to current and future biotechnology crops approved for Australian farming.”

• NSW to get full access to approved GM crops

  May 25, 2021 11:42 am Comments Off on NSW to get full access to approved GM crops

  Farmers in New South Wales will be able to access all approved genetically modified (GM) crops, following the government’s announcement in early March that it would not seek to extend the moratorium due to expire on 1 July.

  This will bring NSW into line with all other mainland states and Australia’s major international agricultural competitors. Such a decision allows farmers to grow what best fits their needs and business model, which is crucial as they face periods of drought and increasingly harsher conditions in a changing climate.

  GM crops are not new to NSW. Farmers have grown GM cotton and GM canola since 1996 and 2008 respectively through specific exemptions.

  Since the adoption of GM cotton in the mid-90s, cotton growers have reduced pesticide use by 97 per cent per bale with the average number of insecticide sprays each season down to three, in comparison with an average of 11 sprays prior to its introduction. This significant reduction in insecticide use, coupled with better pest management, has contributed to on-farm savings, reduced CO2 emissions and improved sustainability.

  The NSW agricultural sector is highly trained and experienced in managing the co-existence of GM and non-GM crops on farm and in the supply chain. All the processes for accreditation, licensing or stewardship are already in place with the NSW Farmers’ Association in support of the use of approved biotechnology to progress agricultural production and improve choice for all farmers.

  The expiration of the moratorium will encourage stronger research and innovation and facilitate access to current and future GM crops approved for commercialisation.

• Plant-based vaccines

  11:40 am Comments Off on Plant-based vaccines

  Due to COVID-19, everybody is talking about vaccines. But did you know we can use plants to produce vaccines, in a safe, rapid and scalable way?

  Medicago, a biopharmaceutical company based in Canada is doing just that using innovative plant-based technologies to provide rapid responses to emerging global health challenges, developing vaccines and therapeutics. Medicago is known for the production in plants of “virus-like particles” (VLP), that mimic the structure of viruses. VLP, once purified, can be used as vaccines, inducing an immune response without causing infection. So far, the technology has been used to develop vaccines against viruses such as the flu, or viruses causing severe vomiting and diarrhea.

  The technology allows for the rapid production of a vaccine that matches circulating variants.

  The Australian National University has recently signed a five-year collaboration with Medicago to develop new methods for monitoring the growth and performance of the plants producing VLP, in a non-invasive way. The Centre for Entrepreneurial Agri-Technology (CEAT) played a crucial part in bringing a cross-disciplinary team together from the ANU College of Engineering and Computer Science and the ANU node of the Australian Plant Phenomics Facility (APPF). The APPF is enabled by the National Collaborative Research Infrastructure Strategy and this project reflects the aim of NCRIS to support high-quality research that will drive greater innovation and address key national and global challenges.

  CEAT was founded by the ANU, CSIRO and the ACT Government in 2018 and has since become an ANU Innovation Institute. CEAT’s mission is to bring together experts from a range of disciplines to collaborate with producers, industry and end-users, to co-design innovative solutions to challenges facing agriculture in Australia and beyond.

• Modernising Australia’s Gene Technology Scheme

  11:38 am Comments Off on Modernising Australia’s Gene Technology Scheme

  Following the Third Review of the National Gene Technology Scheme, the Federal Department of Health is seeking to modernise and futureproof Australia’s National Gene Technology Scheme. This presents an opportunity for Australia to remain a world-leader in biotechnology regulation.

  In 2018 the Legislative and Governance Forum on Gene Technology declared that products created through the gene-editing technique SDN-1 would be exempt from regulation given the outcomes were indistinguishable from products created through conventional methods. With biotechnology making huge leaps in the areas of agricultural and medical research, the regulatory system must keep pace. Now is the time to go further and de-regulate gene-editing techniques like SDN-2 and Oligo-Directed Mutagenesis (ODM), the products of which could quite literally save lives.

  These types of techniques were used in the new cancer treatment known as CAR T-cell therapy, via the product Kymriah® (tisagenlecleucel), which was approved by the Therapeutic Goods Administration of Australia in early 2021. It is used for the treatment of leukaemia and lymphoma in patients where alternative treatment options have been exhausted.

  CAR T-Cell therapy is a once-off, individualised treatment that uses gene-editing techniques beyond the capability of SDN-1 to reprogram the patient’s own T-cells to fight cancer.

  Prior to approval, Australians receiving immunotherapy were required to have blood collected and sent overseas to undergo the reprogramming process before the cells could be returned and used for treatment.

  Enabling Australia’s first onshore commercial manufacture of the therapy substantially reduced patient treatment time. Government approval also led to subsidised access to the treatment, providing eligible patients with new hope and the prospect for improved quality of life.

  Due to this approval, institutions such as the Peter MacCallum Cancer Centre can continue to explore the technology and expand possibilities for the treatment of other cancers.

  Interest in agricultural applications for these techniques is also growing. In late 2020, a Japanese start-up was granted approval by Japanese regulators for the commercial release of a new tomato variety with enhanced nutritional properties. The tomato was gene-edited to increase the accumulation of the naturally occurring amino acid, gamma-aminobutryric Acid (GABA). It has nutritional benefits for treating metabolic disorders and reducing blood pressure and stress.

  Set for release in May 2021, the Sicilian Rouge High GABA tomato will be the world’s first direct consumption gene-edited tomato.

  Widespread government-led marketing campaigns in Japan to educate consumers about the difference between genetically modified organisms (GMOs) and gene-edited crops, means there is a higher level of understanding and acceptance of these products than in other parts of the world.

  The Sicilian Rouge High GABA tomato took over 15 years to produce. Commercialisation was only viable because unnecessary regulation was removed providing clarity on gene-edited plants and their products where they are developed comparably to natural processes of genetic mutation.

  Many applications of SDN-2 and ODM use site-specific guides and repair templates that allow for highly specified changes and predictable outcomes in comparison to randomly induced mutations when using SDN-1 techniques. This increased specificity not only accelerates product development but allows for greater predictability and increased success of the desired alteration.

  Continuing to regulate techniques such as SDN-2 and ODM which have a history of safe use as genetic modification will hamper the development of critical technologies in medicine and new nutritious produce choices.