Molecular Diagnostics Solutions
Molecular diagnostics is a technology that applies molecular biology methods to diagnose diseases by detecting changes in the structure or expression levels of genetic material in a tested individual or in viruses/pathogens they carry. Its primary targets for detection are nucleic acids (DNA and RNA) and proteins, with nucleic acids being the main focus.
Compared to well-established technologies like immunodiagnostics and biochemical diagnostics, molecular diagnostics is in a phase of rapid growth and represents the fastest-growing segment within the in vitro diagnostics (IVD) field. It offers advantages such as short detection time, high sensitivity, and strong specificity. It is widely applied in areas including infectious diseases, prenatal and preconception care, blood screening, genetic disorders, and companion diagnostics for cancer. Among these, infectious diseases account for the largest share and demonstrate the most significant clinical value.
➢ The Evolution of Molecular Diagnostics
The rapid development of molecular diagnostics represents nothing less than the fourth revolution in in vitro diagnostics (IV). The double-helix model of DNA, proposed by Watson and Crick in 1953, was a landmark achievement that laid a solid theoretical foundation for the growth of molecular biology and the advancement of molecular diagnostic technologies.
➢ Molecular Diagnostic Technologies
As the fastest-growing segment within the IVD field, molecular diagnostics is powered by a variety of technological pathways that enable its broad application. Key technologies primarily include PCR (conventional PCR, qPCR, and dPCR), fluorescence in situ hybridization (FISH), gene chips, and second-generation high-throughput sequencing (NGS). Among these, PCR is currently the most mature in application and holds the largest market share.
Technology | Principle | Advantages | Disadvantages | Main Application Fields |
PCR | DNA denatures into single strands at high temperatures and reanneals into double strands at lower temperatures based on the principle of complementary base pairing. | High sensitivity; | Detects only a single locus per assay; | Infectious diseases, Early cancer screening, Companion diagnostics, Blood screening, Genetic disorders, Consumer-grade genetic testing, Genomic sequencing. |
FISH | Uses fluorescently labeled, known-sequence nucleic acid probes to hybridize in situ with target DNA in cells or tissue sections, enabling the localization, identification, and relative quantification of specific nucleic acid sequences. | High sensitivity; | High cost; | Infectious diseases, Early cancer screening. |
Gene Chip | Based on sequencing by hybridization: probes with known sequences are fixed on a chip to hybridize with target nucleotides, determining complementary sequences. | High throughput; | High development complexity; | Consumer-grade genetic testing, Early cancer screening, Drug (R&D), Genomic sequencing. |
NGS | Template DNA molecules are chemically modified and anchored to nano-pores or microcarrier chips. Using the principle of base complementarity, fluorescent signals or chemical reaction signals are captured to interpret the nucleotide sequence. | High throughput; | Complex experimental procedure; | Infectious diseases, Early cancer screening, Companion diagnostics, NIPT, Reproductive health, Genomic sequencing, Drug (R&D). |
As a high-quality reagent provider for life science research and a specialized supplier of core raw materials in the molecular diagnostics field, TransGen offers comprehensive molecular diagnostic solutions to meet the diverse research needs of its customers. The portfolio includes a full range of core components—from sample pre-processing to detection—such as sample preservation solutions, column-based/magnetic bead nucleic acid extraction reagents, Taq DNA polymerase, reverse transcriptase, RT-qPCR/qPCR kits, UDG enzyme, and NGS library preparation products. Additionally, TransGen provides instruments including automated nucleic acid extraction systems, gradient PCR machines, and real-time PCR systems, supporting the advancement of the molecular diagnostics industry.
Nucleic Acid Extraction
➢ MagicPure® Viral DNA/RNA Kit (EC301)
• Simple Operation, no centrifugation required.
• Fast processing with high yield.
• No proteinase K needed; delivers pure products.
• Utilizes silica magnetic beads for targeted viral DNA/RNA purification, compatible with high-throughput magnetic rod-based extraction systems.
• Suitable for serum, plasma, whole blood, tissue homogenates, cell-free body fluids, nasopharyngeal or oropharyngeal aspirates/wash fluids, bronchoalveolar lavage fluid, tracheal aspirates and sputum, nasopharyngeal or oropharyngeal swabs, and cultured animal cell supernatants.
➢ MagicPure® Cell-Free DNA Kit II (EC211)
• Simple, fast procedure with no centrifugation required.
• Delivers high yield and high purity.
• Suitable for human serum or plasma.
➢ MagicPure® FFPE Tissue Genomic DNA Kit (EC701)
• Rapid extraction with high yield.
• Utilizes buffers optimized for FFPE tissue and highly efficient magnetic beads that specifically bind DNA, effectively removing contaminants like proteins and salts.
• Suitable for fresh formalin-fixed paraffin-embedded (FFPE) tissue blocks, sections, and formaldehyde-fixed tissues.
➢ MagicPure® Stool and Soil Genomic DNA Kit (EC801)
• Simple procedure with no tedious steps like heating or ice bathing.
• The Humic Acid Removal system efficiently removes inhibitors from samples, yielding high-quality soil DNA.
• Broad compatibility with various soil types and fecal samples.
PCR Series
Lyophilizable qPCR Master Mix
➢ PerfectStart® IV Fast Probe qPCR SuperMix UDG (AQ732)
• High Specificity & Efficiency: Utilizes three distinct antibody blocks to deliver superior specificity, sensitivity, and amplification efficiency.
• Advanced Reaction Buffer: A specially optimized qPCR buffer provides even greater sensitivity and specificity.
• Robust Contamination Control: Incorporates UDG enzyme and dUTP to effectively prevent carryover contamination, ensuring data accuracy.
• Broad Application Range: Successfully validated for the detection of various pathogens, including African Swine Fever Virus, Pseudorabies Virus, Vibrio harveyi, Enterocytozoon hepatopenaei (EHP), and Vibrio parahaemolyticus.
• Excellent Stability: Maintains stable amplification performance under challenging conditions, including repeated freeze-thaw cycles, and storage as a pre-mix or at elevated temperatures (e.g., ambient temperature, 37°C).
• Ready-to-lyophilize Format: A lyophilizable version is available for easy storage and transportation.
Lyophilizable RT-qPCR Master Mix
➢TransScript® II Multiplex Probe One-Step qRT-PCR SuperMix UDG (AQ322)
• Enables highly efficient first-strand cDNA synthesis from RNA followed by direct qPCR in a simplified procedure, minimizing the risk of handling contamination.
• Incorporates UDG enzyme and dUTP to effectively prevent carryover contamination from PCR amplicons, ensuring the integrity and accuracy of your data.
• Delivers exceptional sensitivity and specificity for reliable and precise detection.
• Successfully validated for the detection of a wide range of pathogens, including SARS-CoV-2, Influenza Virus, Classical Swine Fever Virus, PRRSV, Bovine Viral Diarrhea Virus, Decapod Iridescent Virus 1, White Spot Syndrome Virus, and Taura Syndrome Virus.
• A ready-to-lyophilize version is available, offering enhanced stability and convenience for storage and transport.
Isothermal Amplification
➢ Bst II DNA Polymerase (LP301)
• Simple Procedure: The master mix contains all necessary components; you only need to provide the template and primers/probes.
• High Efficiency: Exhibits strong strand displacement and polymerase activity, enabling rapid, highly efficient, and specific LAMP amplification under constant temperature.
• Visual Operation: Amplification results can be interpreted with the naked eye.
• dUTP/UDG Compatibility: Demonstrates excellent tolerance to dUTP. The addition of dUTP/UDG effectively prevents carryover contamination from LAMP amplicons, ensuring data accuracy.
➢ Bst III Fluorescent LAMP Kit (DNA&RNA) (LP312)
• Includes all necessary reaction components; only require user-provided template and primers.
• Provides excellent detection sensitivity and strong tolerance to inhibitors.
• Suitable for fluorescent RT-LAMP reactions using both DNA and RNA templates.
• Optional lyophilization formats are available upon request.
➢ Bst III Probe LAMP Kit (DNA&RNA) (LP313)
• Includes all necessary reaction components; only require user-provided template and primers/probes.
• Provides excellent detection sensitivity and strong tolerance to inhibitors.
• Suitable for fluorescent RT-LAMP reactions using both DNA and RNA templates.
• Optional lyophilization formats are available upon request.
➢ Colorimetric pH Sensitive LAMP Kit (DNA/RNA) (LP321)
• Enables fast amplification for quick results.
• Strong Strand Displacement Activity.
• Suitable for isothermal amplification (LAMP/RT-LAMP) using both DNA and RNA templates.
• Contains the visual pH indicator N-Red, allowing direct observation of color change with the naked eye.
UDG Enzyme
➢ Uracil-DNA Glycosylase (Low Temperature) (LU201)
• High Digestion Efficiency: Reaction setup can be performed at room temperature. Contaminated dU-containing templates can be degraded in just 1 minute.
• Low PCR Inhibition: Even at a concentration of up to 80 U/mL (equivalent to adding 4 Units in a 50 μL PCR system), it shows no significant inhibition of the PCR reaction.
• Broad Application Range: Suitable for PCR/qPCR, RT-PCR/RT-qPCR, LAMP/RT-LAMP, and other amplification reactions.
• Simple Procedure: Requires no dedicated digestion step or incubation.
NGS
DNA Library Preparation
➢ TransNGS® Tn5 DNA Library Prep Kit for Illumina® (for 5 ng/50 ng/1 ng DNA) (KP101/KP111/KP121)
• Utilizes an in vitro transposition method, enabling simultaneous DNA fragmentation and adapter ligation within just 5 minutes.
• Features a short library preparation time and a simple, streamlined workflow.
• Requires a low input amount of DNA.
• The resulting libraries are compatible with both single-end and paired-end sequencing.
➢ TransNGS® DNA Library Prep Kit for Illumina® (KP201)
• Ideal for efficient and rapid construction of DNA libraries from 1 ng to 1 μg of fragmented double-stranded (ds) DNA.
• Traditional library preparation methods require multiple steps: DNA fragmentation, end repair, and adapter ligation.
• Compatible with a wide range of sample types.
• Achieves high library conversion efficiency.
➢ TransNGS® DNA Library Prep Kit for MGI® (KP221)
• Broad Sample Applicability.
• High Library Conversion Efficiency.
• Superior Data Output Quality.
➢ TransNGS® Fragmentase DNA Library Prep Kit for Illumina® (KP231)
• Utilizes an enzymatic fragmentation library prep method to complete DNA fragmentation, end repair, and A-tailing in a single tube. The reaction product can be directly used for adapter ligation without a purification step.
• Features a short library construction time and a simple, user-friendly workflow.
• Compatible with a wide range of sample types.
• Delivers high library conversion efficiency.
➢ TransNGS® Fragmentase DNA Library Prep Kit for MGI® (KP241)
• Efficiently constructs high-quality DNA libraries from a wide input range of 1 ng to 1 μg of dsDNA.
• Utilizes an enzymatic fragmentation library prep method to complete DNA fragmentation, end repair, and A-tailing in a single tube.
• Features a short library construction time and a simple, user-friendly workflow.
• Compatible with a wide range of sample types.
• Delivers high library conversion efficiency.
RNA Library Preparation
➢ TransNGS® Fast RNA-Seq Library Prep Kit for Illumina® (KP701)
• Builds strand-specific or non-strand-specific transcriptome libraries for Illumina sequencing.
• Integrates second-strand synthesis, end repair, and A-tailing in a single-tube reaction.
• Complete library preparation in approximately 3 hours.
• High library conversion efficiency.
• Generates high-quality sequencing data.
➢ TransNGS® Fast Stranded RNA-Seq Library Prep Kit for MGI® (KP801)
• Builds strand-specific or non-strand-specific transcriptome libraries for MGI sequencing.
• Integrates second-strand synthesis, end repair, and A-tailing in a single-tube reaction.
• Complete library preparation in approximately 3 hours.
• High library conversion efficiency.
• Generates high-quality sequencing data.
mNGS Library Preparation
➢ TransNGS® Host DNA Depletion Kit (EH301)
• Simple & Fast: Features a straightforward protocol that removes human host DNA in just 50 minutes.
• Highly Effective Depletion: Uses a specialized lysis buffer to efficiently remove host nucleic acids, significantly improving the detection rate of microbial pathogens.
• Broad Sample Compatibility: Ideal for a wide range of clinical samples, including oral/throat swabs, sputum, pleural fluid, ascitic fluid, cerebrospinal fluid (CSF), and amniotic fluid.
• Flexible Downstream Integration: Compatible with various downstream nucleic acid extraction methods, including column-based and magnetic bead-based systems.
➢ MagicPure® Microbiome DNA Isolation Kit (EC107)
• Yields high-purity DNA/RNA ideal for a wide range of demanding downstream applications (e.g., PCR, NGS).
• Reagents are rigorously controlled for background microbial contamination to ensure result reliability.
• Efficiently extracts microbial nucleic acids from throat swabs, sputum, pleural fluid, ascitic fluid, and more.
• Optimized for use with magnetic rod-based automated nucleic acid extraction systems.
➢ TransNGS® Microbiome DNA Library Prep Kit for Illumina® (KP141)
• Rapid Workflow: Complete library preparation in under 90 minutes.
• Simplified Operation: A single-tube enzymatic reaction simultaneously performs DNA fragmentation and adapter ligation.
• Unmatched Versatility: The transposase-based method is robust and adaptable for a wide variety of DNA templates.
• Low Input Requirement: Successfully generates libraries from DNA inputs as low as 1 ng.
Driven by quality, devoted to service. TransGen Biotech provides the critical tools and expertise to bridge the gap between concept and commercial molecular diagnostic solutions.
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