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Environmental risk assessment for genetically modified microalgae (Publication Date: Aug 2026)

Abstract: Advances in genomic techniques have great potential to accelerate the development of the microalgal sector and to address key challenges related to upscaling. Genetically modified microalgae (GMM) can exhibit enhanced biomass productivity, increased accumulation of valuable biocompounds, or express other beneficial traits compared to their non-modified counterparts. However, the application of GMM and their associated cultivation methods may lead to unintentional release, potentially a ...

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bch-vlr-scbd-300860-1
Article
01 Sep 2026

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Gene Drive Monitor (Publication Date: Jan 2023)

The database includes: (i) Laboratory research and modelling on gene drives as reported in the academic literature and other sources such as press releases from funders and universities; (ii) Proposals for gene drives as identified from the natural sciences literature; (iii) Proposals deriving from other academic literature (such as literature relating to policy or ethics) are included at the discretion of the researchers, for example if such proposals designate novel targets; and (iv) The datab ...

Biosafety Virtual Library Resources
bch-vlr-scbd-300566-2
Online database, Website
11 Aug 2026

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Gene Drive Development in Insect Targets: A Horizon Scanning Survey (Publication Date: Jun 2026)

Summary: Screening and analysis of the scientific literature up to 31 December 2023 showed: (i) Gene drives were developed or proposed in 43 insect species1. Additionally, gene drives were proposed for 5 general taxonomic groups of insects: (ii) Of these 48 insect species or groups the majority are agricultural pests, 28 in total, while 17 are vectors of human disease, in particular malaria. The agricultural pests include 6 livestock pests or livestock disease vectors, which partially overlap wi ...

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bch-vlr-scbd-300564-2
Report
11 Aug 2026

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Gene Drive Development in Non-Insect Targets – including Vertebrates, Snails, Fungi and Plants: A Horizon Scanning Survey up to end 2023 (Publication Date: Apr 2026)

Summary: Screening and analysis of the scientific literature for gene drive development in non-insect targets up to 31 December 2023,1 showed: (i) There are 46 current or proposed non-insect targets; (ii) Proposals span a wide range of species and taxonomic groups: from mammals and fish to snails, arachnids, fungi and plants; (iii) In the vast majority of cases the aim is to suppress or eradicate the target; (iv) Compared to gene drive systems in insects, the systems in other taxonomic groups ar ...

Biosafety Virtual Library Resources
bch-vlr-scbd-300565-1
Report
11 Aug 2026

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Cutting through the hype in synthetic biology: Will gene drives work? (Publication Date: Oct 2025)

Excerpt: Using analogies from engineering, the field of synthetic biology has put forth a vision of biology by design. Some practitioners have acknowledged that it has been used by some to promise ‘easy solutions to difficult problems’ and warn that it must not be framed as ‘the one technical solution to many grave world problems’. Engineered gene drives (EGD) are a form of synthetic biology that have attracted much investment and attention by promising just such easy solutions to serious proble ...

Biosafety Virtual Library Resources
bch-vlr-scbd-300563-1
Article
11 Aug 2026

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Biosafety Technical Series 07: Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives (Publication Date: Oct 2025)

Table of contents: (1) Objective and scope; (2) Introduction; (3) Engineered gene drives; (4) General risk assessment considerations for living modified organisms containing engineered gene drives; (5) Recommendation of acceptability of risk and identification of risk management strategies; (6) Monitoring; and (7) Related issues. Annexes: I (Further information on modelling); II (Further information on uncertainty); III (World Health Organization guidance framework for testing genetically modif ...

Biosafety Virtual Library Resources
bch-vlr-scbd-280754-3
Guide, Guidelines, Technical guide
16 Jul 2026

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Biosafety Symposium 2025 (Publication Date: Mar 2026)

The Biosafety Symposium 2025 Report captures the discussions of this event that was held on 21 August 2025 in Shah Alam, Malaysia. This event was organized by the Department of Biosafety (DOB) under the Ministry of Natural Resources and Environmental Sustainability (NRES) attended by 412 participants and experts from Malaysia, Singapore, Indonesia, Thailand, the Philippines, and the United Kingdom. The symposium’s theme, "Strengthening Biosafety for Future Sustainability," focused on fostering r ...

Biosafety Virtual Library Resources
bch-vlr-scbd-299953-1
Report, Best practices
13 Jul 2026

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Guidelines for the single-laboratory validation of qualitative real-time PCR methods (Publication Date: Nov 2016)

The present guidelines for single-laboratory validation of qualitative real-time PCR methods were developed by the international working group "Development of methods for the identification of food produced by genetic engineering", established pursuant to § 64 of the German Food and Feed Code. It aims to ensure that qualitative real-time PCR methods developed by this group are able to meet the performance criteria defined at the European (ENGL, CEN) and international (ISO, Codex) level. The guid ...

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bch-vlr-scbd-293575-2
Article, Manual, Methodologies, Technical guide
25 Mar 2026

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Guidelines for the validation of qualitative real-time PCR methods by means of a collaborative study (Publication Date: Mar 2016)

The present guidelines for conducting a collaborative validation study of qualitative real-time PCR methods were developed by the international working group "Development of methods for the identification of food produced by genetic engineering" established pursuant to § 64 of the German Food and Feed Code. It aims to ensure that respective methods can meet the performance criteria defined at the European (ENGL, CEN) and international (ISO, Codex) level. The main criterion for validation a quali ...

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bch-vlr-scbd-293576-1
Article, Manual, Methodologies, Technical guide
25 Mar 2026

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Detection of food and feed plant products obtained by targeted mutagenesis and cisgenesis (Publication Date: Jun 2023)

Author's Abstract. The current EU legislation on GMOs and food and feed containing GMOs requires analytical testing to support traceability of these products on the market. Here the European Network of GMO Laboratories has reviewed the implications of the analytical requirements when they are applied to plant products developed by new genomic techniques, i.e. targeted mutagenesis and cisgenesis. This review concluded that analytical testing to support traceability is not considered feasible for ...

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bch-vlr-scbd-281905-1
Report
15 Jan 2026

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Considerations for the Successful Detection and Quantification of Genetically Modified Events in Grain and Food Samples Using Multiplex Digital PCR (Publication Date: Dec 2024)

Author's Abstract. The number of genetically modified (GMO) events for canola, corn, and soybean is steadily increasing. Some countries, including those in the EU, have regulatory requirements for the approval and use of plant ingredients containing GMOs. Multiplex digital PCR (dPCR) has been used for the simultaneous detection and quantification of various GMO events. This review covers the various factors to consider for multiplex digital PCR detection and the quantification of GMO events. DN ...

Biosafety Virtual Library Resources
bch-vlr-scbd-281904-1
Article
15 Jan 2026

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ddPCR strategy to detect a gene-edited plant carrying a single variation point: Technical feasibility and interpretation issues (Publication Date: Mar 2022)

Author's Abstract. Gene-edited organisms and derived food and feed products commercialized on the European market falls within the scope of the Directive, 2001/18/EC. Therefore, the possibility to specifically detect and quantify them has become a priority. To this end, PCR-based approaches, such as real-time PCR and digital droplet PCR, targeting a single variation point carried by a gene-edited organism are expected to be suitable, even if potentially challenging at the technical level. Howev ...

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bch-vlr-scbd-281901-2
Article
15 Jan 2026

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A Novel Quantification Method for Gene-Edited Animal Detection Based on ddPCR (Publication Date: Feb 2025)

Author's Abstract. As gene-editing technologies continue to evolve, gene-edited products are making significant strides. These products have already been commercialized in the United States and Japan, prompting global attention to their safety and regulatory oversight. However, the detection of gene editing still relies on qPCR, and there is a lack of quantitative detection methods to quantify gene-editing components in products. To ensure consumer safety and transparency, we developed a novel ...

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bch-vlr-scbd-281899-1
Article
15 Jan 2026

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Detection method for CRISPR-Cas9 edited tomato with single nucleotide deletion using multiplex probe-based real-time PCR and confirmation of non-transgenicity: A case study (Publication Date: Oct 2025)

Author's Abstract. The adoption of gene-edited (GE) food crops has increased due to applicability of technology without drastically affecting the genetic information. However, the discussion on regulatory regime pertaining to GE plants throughout the globe is overwhelming. In the countries where GE products are regulated, or for the verification of gene-editing as claimed by the developers, detection of GE plants (referred to as GE detection here) plays an imperative role. Precisely detecting s ...

Biosafety Virtual Library Resources
bch-vlr-scbd-281897-1
Article
15 Jan 2026

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Future perspectives of GMO detection in agriculture: strategies for electrochemical nucleic acid detection (Publication Date: Jun 2025)

Author's Abstract. The uncontrolled distribution of genetically modified organisms (GMO)-based food and feed is an increasing global concern, primarily due to limited information about their potential harmful effects. The growing diversity and complexity of GMOs present significant challenges for their detection, traceability, and safety monitoring. Traditionally, GMOs are detected using molecular methods, among which PCR methods are the most explored and are considered the gold standard. Howev ...

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bch-vlr-scbd-281895-1
Article
15 Jan 2026

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Detection of commercialized plant products derived from new genomic techniques (NGT) - Practical examples and current perspectives (Publication Date: Oct 2023)

Author's Abstract. New genomic techniques (NGT) are increasingly applied in plant research and development in many countries due to their simplicity in introducing genetic modifications that alter specific traits. First NGT products are on the market in several countries where no specific regulatory approval is required. In the European Union (EU), however, all NGT derived products are subject to the existing genetically modified organism (GMO) authorization regulations. This nourishes the disc ...

Biosafety Virtual Library Resources
bch-vlr-scbd-281887-1
Article
14 Jan 2026

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Development and in-house validation of two real-time PCR methods for the detection of genome-editing events in soybean FAD2 gene variants (Publication Date: Jan 2025)

Author's Abstract. Since the commercialization of the first genetically modified (GM) crops, their relevance in agricultural applications has increased. Soybean (Glycine max) ranks as the most widely cultivated GM crop globally. With the advancements in site-specific genome-editing tools, the development of GM organisms (GMO) using new genomic techniques has accelerated, particularly in agriculture. In the US, a genome-edited soybean variety, Calyno, was developed with altered fatty acid composi ...

Biosafety Virtual Library Resources
bch-vlr-scbd-281851-3
Article, Methodologies
14 Jan 2026

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Baseline of Peruvian tomato diversity for biosafety purposes (Publication Date: Dec 2020)

Author summary: The baseline for tomato genetic diversity in Peru, published in 2020, presents a detailed characterization of 17 species of the genus Solanum, including the cultivated tomato (S. lycopersicum) and its wild relatives. Through surveys in 17 regions, traditional agricultural practices, agroecosystems, associated microorganisms, and evidence of the management of native varieties such as S. lycopersicum var. Cerasiforme were identified. The study also includes analyses of floral biolo ...

Biosafety Virtual Library Resources
bch-vlr-scbd-280219-2
Book
12 Jan 2026

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Baseline for ornamental fish for biosecurity purposes in Peru (Publication Date: Dec 2021)

Author summary: The baseline of ornamental fishes in Peru, published in 2021, systematises studies carried out between 2015 and 2019 in the regions of Loreto, Ucayali, San Martin and Madre de Dios, addressing ecological, biological, socioeconomic and cultural aspects. Around 300 native species with ornamental potential were identified, including records of genetic diversity, traditional practices and gene flow. The report incorporates ex ante risk assessments for fluorescent modified live fish, ...

Biosafety Virtual Library Resources
bch-vlr-scbd-280223-2
Book
12 Jan 2026

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Baseline of rainbow trout for biosafety purposes in Peru (Publication Date: Jul 2021)

Author summary: The baseline study on rainbow trout in Peru, published in 2021, brings together studies conducted between 2015 and 2019 in twelve priority regions. It analyzes the distribution of Oncorhynchus mykiss, its reproductive biology, breeding practices, and associated socioeconomic and ecological aspects. The systematization allows for an assessment of the current status of this naturalized species in the country and provides technical input for preventing risks associated with the intr ...

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bch-vlr-scbd-280224-2
Book
12 Jan 2026

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Development and collaborative validation of an event-specific quantitative real-time PCR method for detection of genetically modified CC-2 maize (Publication Date: Sep 2024)

Author Summary: As one of the developed genetically modified (GM) maize varieties in China, CC-2 has demonstrated promising commercial prospects during demonstration planting. The establishment of detection methods is a technical prerequisite for effective supervision and regulation of CC-2 maize. In this study, we have developed an event-specific quantification method that targets the junction region between the exogenous gene and the 5’ flanking genomic DNA (gDNA) of CC-2. The accuracy and pre ...

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bch-vlr-scbd-281850-1
Article, Methodologies
12 Jan 2026

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Detection of Soybean GMO Events Using Two Multiplex Droplet Digital PCR Assays (Publication Date: Oct 2024)

Author Abstract: Background. Detection methods for GMO events are required because of regulatory compliance requirements. Efficient detection and quantification of GMO events saves time and resources. Multiplex digital PCR (dPCR) allows detection and quantification of more than one GMO event at the same time. Objective. The study used two tetraplex droplet digital PCR (ddPCR) assays for the detection of 19 soybean GMO events. Methods. Two multiplex dPCR assays were developed and optimized for t ...

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bch-vlr-scbd-281778-2
Article
12 Jan 2026

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In-House Validation of Four Duplex Droplet Digital PCR Assays to Quantify GM Soybean Events (Publication Date: Dec 2024)

Author Abstract: Due to the increasing number of authorized events in the European Union, it is crucial for the official laboratories to enforce market control to detect and quantify genetically modified organisms. In this study, an in-house validation of quantitative duplex ddPCR methods was performed involving MON87701, MON87769, MON89788 and CV-127-9 assays with respect to the lectin reference gene. Since the ddPCR methods provide accurate quantification, show less sensitivity to PCR inhibito ...

Biosafety Virtual Library Resources
bch-vlr-scbd-281849-1
Article
12 Jan 2026

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Problem formulation for a small-scale field study of non-gene drive, genetically modified, male bias mosquitoes in Burkina Faso (Publication Date: Apr 2025)

Abstract: This article documents the problem formulation step of a risk assessment for a proposed small-scale field release in Burkina Faso of genetically modified (GM) An. coluzzii mosquitoes that carry a Paternal Male Bias (PMB) construct. These mosquitoes are part of the pathway developed by Target Malaria to provide a new cost-effective control strategy for malaria vectors in Africa. The problem formulation describes 7 potentially harmful outcomes that might occur through 19 pathways to harm ...

Biosafety Virtual Library Resources
bch-vlr-scbd-281199-1
Article
03 Dec 2025

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Guatemalan Maize Atlas, "The living Atlas" From the sacred grain to the genome, a multidimensional introduction (Publication Date: Oct 2025)

Courtesy translation of the author's summary: "A living Atlas of native maize of Guatemala is a living image of the culture and biodiversity that we, the residents of this country, preserve. As men and women of maize, learning about, preserving, and expanding our knowledge of one of the species and its varieties, which have nourished our people for thousands of years, makes our hearts beat with excitement every time we know that we will see maize in our food as a faithful companion in life. Farm ...

Biosafety Virtual Library Resources
bch-vlr-scbd-280846-1
Book, Fact sheet
28 Oct 2025

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