Diseases

05 Dec
Categories Diseases, Hematology, Oncology, speciality

Minagene’s Comprehensive Leukemia Panel










Overview


Minagene's Comprehensive Leukemia Panel is a specialized genetic test designed to provide a comprehensive assessment of genetic alterations associated with various types of leukemia. This advanced panel employs next-generation sequencing (NGS) technology to analyze a wide range of genes known to be involved in leukemia development and progression. By unraveling the genetic landscape of leukemia, this panel aids in precise diagnosis, risk stratification, and personalized treatment selection for improved patient outcomes.


Methodology



The Comprehensive Leukemia


The Comprehensive Leukemia Panel utilizes NGS technology to analyze DNA or RNA extracted from leukemia samples. The panel covers a broad spectrum of genes associated with different leukemia subtypes, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and others. The analysis detects various types of mutations, including single nucleotide variants (SNVs), insertions/deletions (indels), gene fusions, and copy number variations (CNVs), providing a comprehensive genetic profile of the leukemia.


Key Highlights of the Test:


Key Highlights of the Test:


-Comprehensive Genetic Evaluation: The Comprehensive Leukemia Panel performs a comprehensive evaluation of genes associated with different types of leukemia. By analyzing a wide range of genetic alterations, including driver mutations and recurrent gene fusions, the panel provides a detailed genetic profile, aiding in accurate diagnosis and risk stratification.


-Precise Diagnosis and Subtyping: The panel helps in precise diagnosis and subtyping of leukemia by identifying specific genetic alterations associated with different subtypes. This information is valuable for guiding treatment decisions and selecting subtype-specific therapeutic approaches.


-Risk Stratification: The identification of specific genetic alterations through the panel enables risk stratification, which helps predict disease aggressiveness and patient prognosis. By assessing the presence of high-risk genetic markers, clinicians can tailor treatment strategies, including the intensity and duration of therapy, to optimize patient outcomes.


-Personalized Treatment Selection: The Comprehensive Leukemia Panel facilitates personalized treatment selection by identifying actionable genetic alterations that can guide targeted therapies. The panel’s findings can assist in the selection of appropriate targeted agents or clinical trials, improving treatment response and long-term outcomes.


-Monitoring Treatment Response and Minimal Residual Disease: Serial analysis using the panel allows for monitoring treatment response and detecting minimal residual disease. By tracking changes in the genetic profile over time, clinicians can assess treatment efficacy, identify emerging resistance mechanisms, and guide treatment modifications for optimal disease control.


When to Consider This Test


-Leukemia Diagnosis: The Comprehensive Leukemia Panel is recommended for patients with suspected or newly diagnosed leukemia. The panel aids in precise diagnosis, subtyping, and risk stratification, providing critical information for treatment planning.


-Treatment Decision-Making: The test is valuable for treatment decision-making by identifying actionable genetic alterations that guide targeted therapy selection. It helps identify patients who may benefit from specific targeted agents, immunotherapies, or clinical trials based on their genetic profile.


-Risk Stratification: The panel assists in risk stratification, enabling clinicians to identify patients at higher risk of disease progression or relapse. This information helps determine the appropriate treatment intensity, including the need for more aggressive therapy or stem cell transplantation.


-Treatment Response Monitoring: Serial testing using the Comprehensive Leukemia Panel enables the monitoring of treatment response and the detection of emerging resistance mechanisms. This information guides treatment adjustments and ensures optimal disease control.


-Minimal Residual Disease Monitoring: The panel can be utilized to monitor minimal residual disease status in patients who have achieved remission. Detecting residual genetic alterations helps assess treatment response and guides decisions regarding treatment duration and the need for additional interventions

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03 Dec
Categories Diseases, Oncology, Pulmonology, speciality

Minagene’s EGFR Gene Testing










Overview


Minagene's EGFR Gene Testing is a specialized genetic analysis designed to identify mutations within the Epidermal Growth Factor Receptor (EGFR) gene in patients with lung cancer. This comprehensive testing approach utilizes state-of-the-art techniques, including next-generation sequencing (NGS) and other molecular methodologies, to detect EGFR mutations. By providing valuable genetic insights, this test aids in personalized treatment decision-making, particularly in the context of targeted therapies for lung cancer.


Methodology



he EGFR Gene Testing


The EGFR Gene Testing employs NGS technology to analyze the DNA extracted from tumor samples or circulating tumor DNA (ctDNA). This approach allows for the detection of various EGFR mutations, including exon 19 deletions, exon 21 L858R point mutations, and other less common alterations. The test also assesses the presence of EGFR T790M mutation, which is associated with resistance to EGFR tyrosine kinase inhibitors (TKIs).


Key Highlights of the Test:


Key Highlights of the Test:


-Detection of EGFR Mutations: The EGFR Gene Testing identifies mutations within the EGFR gene, providing crucial information about the genetic profile of the tumor. It enables the detection of common activating mutations, such as exon 19 deletions and exon 21 L858R point mutations, as well as less common alterations within the EGFR gene.


-Personalized Treatment Selection: By identifying EGFR mutations, the test helps guide personalized treatment decisions, particularly in the context of targeted therapies for lung cancer. Patients with EGFR mutations may be candidates for EGFR TKIs, which have shown efficacy in this specific molecular subtype of lung cancer.


-Resistance Mechanism Assessment: The EGFR Gene Testing also assesses the presence of the EGFR T790M mutation, which is associated with acquired resistance to EGFR TKIs. Detection of this mutation is crucial for identifying patients who may benefit from alternative treatment strategies, such as third-generation EGFR TKIs or combination therapies.


-Monitoring Treatment Response: The test can be utilized to monitor treatment response and disease progression by detecting changes in EGFR mutation status over time. This enables physicians to assess treatment efficacy, identify emerging resistance mechanisms, and make informed decisions regarding treatment adjustments.


When to Consider This Test:


-Newly Diagnosed Lung Cancer: The EGFR Gene Testing should be considered in patients with newly diagnosed lung cancer, particularly those with non-small cell lung cancer (NSCLC), as EGFR mutations are more prevalent in this subtype. Identifying EGFR mutations at the time of diagnosis helps guide treatment decisions and optimize therapy for improved patient outcomes.


-Targeted Therapy Selection: The test is essential for selecting the most appropriate targeted therapy for patients with lung cancer harboring EGFR mutations. Positive EGFR mutation status is a predictive biomarker for the efficacy of EGFR TKIs, allowing for personalized treatment selection and optimization.


-Treatment Resistance Evaluation: In patients who initially respond to EGFR TKIs but later develop resistance, the EGFR Gene Testing can identify the EGFR T790M mutation, which is a common mechanism of acquired resistance. Detecting this mutation helps guide the selection of alternative treatment options to overcome resistance and improve treatment outcomes.


-Disease Progression Monitoring: The test can be used to monitor disease progression and treatment response over time. Serial testing enables the detection of emerging resistance mechanisms, guiding treatment adjustments and optimizing long-term management.

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03 Dec
Categories Diseases, Oncology, Pathology, speciality

Minagene’s OncoTrack










Overview


Minagene's OncoTrack is a state-of-the-art genomic profiling test designed to empower physicians in delivering precision oncology for patients with cancer. By employing advanced molecular techniques and comprehensive genomic analysis, OncoTrack enables the identification of actionable genetic alterations in tumors, providing valuable insights into treatment selection, prognosis, and therapeutic monitoring. With its cutting-edge technology and extensive gene coverage, OncoTrack revolutionizes cancer management by facilitating personalized treatment strategies.


Methodology



OncoTrack utilizes


OncoTrack utilizes next-generation sequencing (NGS) technology, capturing and analyzing tumor DNA from patient samples. This approach enables the identification of key genetic alterations, including somatic mutations, copy number variations (CNVs), gene fusions, and other relevant genomic changes. By comparing the tumor DNA with the patient’s normal DNA, OncoTrack precisely detects tumor-specific alterations, allowing for a comprehensive genomic profiling of the cancer.


Key Highlights of the Test:


Key Highlights of the Test:


-Comprehensive Gene Coverage: OncoTrack covers a wide range of cancer-associated genes, including those known to be frequently mutated or involved in various oncogenic pathways. This comprehensive gene coverage ensures that physicians obtain a detailed understanding of the genetic landscape of the tumor, enabling personalized treatment decisions.


-Actionable Insights for Treatment: OncoTrack provides actionable insights by identifying genetic alterations that have known associations with targeted therapies, immunotherapies, or clinical trials. This information empowers physicians to select the most effective treatment options for their patients, maximizing the chances of treatment success.


-Prognostic and Predictive Markers: The test identifies prognostic markers that provide valuable information about the patient’s disease trajectory, facilitating prognostic evaluation and aiding in long-term care planning. Additionally, OncoTrack identifies predictive markers, enabling the prediction of treatment response and resistance, thereby guiding treatment selection and monitoring.


-Tumor Heterogeneity Assessment: OncoTrack offers the ability to assess intratumoral heterogeneity, identifying clonal and subclonal alterations within the tumor. This information enhances the understanding of tumor evolution, resistance mechanisms, and potential therapeutic vulnerabilities, enabling a more comprehensive and personalized treatment approach.



When to Consider This Test:


-Treatment Selection: OncoTrack assists physicians in selecting targeted therapies or immunotherapies based on the identified genetic alterations in the tumor. By matching the genetic profile of the tumor with available treatment options, physicians can tailor treatment regimens to maximize therapeutic efficacy.


-Prognostic Evaluation: The test provides valuable prognostic information by identifying genetic markers associated with disease progression, recurrence, or overall survival. This aids in risk stratification and helps guide treatment decisions and long-term care plans.


-Therapeutic Monitoring: OncoTrack enables serial monitoring of genetic alterations during the course of treatment. By tracking changes in the tumor’s genomic profile over time, physicians can assess treatment response, detect emerging resistance mechanisms, and make informed decisions regarding treatment adjustments.


-Clinical Trial Eligibility: OncoTrack identifies genetic alterations that match ongoing clinical trials, potentially offering patients access to novel therapies and expanding their treatment options beyond standard-of-care approaches.

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03 Dec
Categories Diseases, Infectious Diseases, Pulmonology, speciality

Minagene’s Tuberculosis Diagnostics Solution










Overview


Minagene's proprietary solution utilizes whole-genome sequencing directly from sputum and other clinical samples to rapidly detect Mycobacterium tuberculosis complex and identify genetic mutations associated with drug resistance.


Methodology



Specimens undergo phenol-chloroform


Specimens undergo phenol-chloroform extraction followed by Nextera XT library preparation and Illumina sequencing. A curated pathogen database enables identification of Mtb from sequencing reads. Algorithms further characterize resistance-conferring variants across all anti-TB drug targets.


Key Highlights of Minagene’s Tuberculosis Diagnostics Solution


Key Highlights of Minagene’s


-Detects Mtb directly from specimens in hours, not weeks


-Sensitively identifies non-tuberculous mycobacteria


-Assesses mutations for all first and second-line drugs


-Predicts multidrug resistant/extensively drug resistant profiles


-Guides early optimization of personalized treatment regimens


By applying an unbiased meta’omic approach, this solution resolves diagnostic delays impairing TB control. Rapid resistance data supports effective empiric therapy selection while limiting further transmission of resistant strains.


When to Consider Minagene’s Tuberculosis Diagnostics Solution


Physicians should utilize Minagene's sequencing-based TB diagnostic in confirmed or suspected cases where rapid anti-microbial stewardship is paramount to improving patient outcomes and public health.

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03 Dec
Categories Diseases, Infectious Diseases, Metabolic Medicine, speciality

Minagene’s Syndrome Evaluation System (SES) of Systemic Infections










Overview


Minagene's proprietary SES utilizes metagenomic sequencing and bioinformatics to establish molecular diagnoses in patients presenting with sepsis, bacteremia or other systemic inflammatory responses of unknown etiology.


Methodology



Blood and other sterile site


Blood and other sterile site specimens are subjected to shotgun sequencing on the Illumina platform post-nucleic acid purification. Metagenomic analysis characterizes the circulating pathogenomic and identifies resistance genes by comparison against curated pathogen databases.


Key Highlights of Minagene’s (SES) of Systemic Infections


Key Highlights of Minagene’s (SES)


-Detects viruses, bacteria, fungi, parasites from whole blood


-Identifies causative organisms in culture-negative cases


-Assesses antibiotic resistance without culture-based assumptions


-Streamlines infection control by specifying pathogenic source


-Returns results within 5 days to guide targeted antimicrobials


By applying an unbiased “whole-microbiome” approach, SES addresses diagnostic challenges in sterile site infections. Simultaneous resistance profiling enables optimized, narrow-spectrum empiric therapy selection.


When to Consider


SES is recommended for evaluation of sepsis, infective endocarditis or other life-threatening systemic infections with negative conventional microbiologic workup requiring fast diagnosis.

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30 Nov
Categories Diseases, Gastroenterology, Infectious Diseases, medical microbiologists, speciality

Gastrointestinal Pathogen Test










Overview


Minagene's proprietary gastrointestinal pathogen panel utilizes multiplex PCR and next-generation sequencing to simultaneously detect over 30 bacterial, viral and parasitic organisms associated with acute and chronic diarrhea.


Methodology



Stool specimens


Stool specimens are treated with a lysis buffer and nucleic acid is extracted. Hypervariable regions are amplified using tiled primers barcoded for each pathogen. Sequencing on the Illumina platform at >10,000x coverage allows for identification of variants associated with antimicrobial resistance.


Key Highlights


Key Highlights


-Identifies causative agents missed by conventional assays


-Screens for emerging enteric pathogens like Cyclospora


-Assesses antibiotic resistance of detected bacteria


-Provides results within 5 days to guide targeted therapy


-Offers cost savings compared to sequential single-target testing



With its unparalleled breadth and speed, Minagene’s stool panel streamlines the diagnostic evaluation of gastroenteritis. Genome-resolved pathogen data assists clinical decision-making and public health monitoring of infectious outbreaks.


When to Consider Minagene’s Gastrointestinal Pathogen Test


This comprehensive test is recommended for patients with severe or prolonged diarrhea, particularly in transplant, oncology or malnourished populations where opportunistic infections necessitate rapid diagnosis and isolation.

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30 Nov
Categories Diseases, Infectious Diseases, medical microbiologists, speciality

Eye Infections Syndrome Evaluation System










Overview


Minagene's proprietary SES protocol concurrently isolates and
identifies causative organisms from bilateral ocular swabs, streamlining diagnosis of bacterial conjunctivitis, blepharitis,
keratitis and endophthalmitis. Deep sequencing with
bioinformatic analyses achieve comprehensive pathogen
detection from a single specimen.


Methodology



The Syndrome Evaluation System


The Syndrome Evaluation System (SES) is a patented technology used for rapid multiplex amplification and accurate identification of virulence-associated genes of causative agents or organisms. This advanced platform surpasses conventional diagnostic tests by providing fast and precise results, especially when organisms are challenging to cultivate or locate. Currently available diagnostic technologies for detecting infections are inadequate, often failing to detect early stages of illness and delaying specific therapy in critical cases, which can lead to functional loss or even loss of life.



The SES amplifies genes


The SES amplifies genes, enhancing the sensitivity of the test. The re-naturation of the amplified signature gene to its chemically identified complementary gene sequence on the SES further improves accuracy.



Key Highlights of Minagene's Eye Infections Test


Higher Accuracy


Detects a greater number of cases compared to conventional methods


Reduction in Testing and Investigations


Avoids the need for multiple testing and unnecessary investigations, leading to cost savings.
Reduces the duration of stay in the intensive care unit (ICU) and associated costs.


Comprehensive Pathogen Detection


– Detects DNA of various pathogens, including fungi, viruses, parasites, and bacteria, in a single test.


-Capable of detecting both unimicrobial and polymicrobial infections.


Efficient Rule-in or Rule-out


Helps in confirming or excluding the presence of infections












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30 Nov
Categories Diseases, Infectious Diseases, Neurology, speciality

CNS Infections Syndrome Evaluation System










Methodology



The Syndrome Evaluation System


The Syndrome Evaluation System (SES) is a patented technology used for rapid multiplex amplification and accurate identification of virulence-associated genes of causative agents or organisms. This advanced platform surpasses conventional diagnostic tests by providing fast and precise results, especially when organisms are challenging to cultivate or locate. Currently, available diagnostic technologies for detecting infections are inadequate, often failing to detect early stages of illness and delaying specific therapy in critical cases, which can lead to functional loss or even loss of life.


The SES amplifies genes, enhancing the sensitivity of the test. The renaturation of the amplified signature gene to its chemically identified complementary gene sequence on the SES further improves accuracy.


Key Highlights of Minagene's CNS Infections Test:


Higher Accuracy


Detects a greater number of cases compared to conventional methods


Reduction in Testing and Investigations


Avoids the need for multiple testing and unnecessary investigations, leading to cost savings


Reduces the duration of stay in the intensive care unit (ICU) and associated costs


Comprehensive Pathogen Detection


Detects DNA of various pathogens, including fungi, viruses, parasites, and bacteria, in a single test.


Capable of detecting both unimicrobial and polymicrobial infections.


Efficient Rule-in or Rule-out


Helps in confirming or excluding the presence of infections


Molecular Basis of Infectious Disease Diagnosis:


Molecular detection


Molecular detection, which involves amplification and hybridization of nucleic acids, has revolutionized the diagnosis of infectious diseases. PCR (Polymerase Chain Reaction) is a commonly used method for nucleic acid detection in clinical laboratories. This approach allows for the direct detection of mutations associated with drug resistance in biological samples without the need for culturing the organism.



molecular basis


The molecular basis of diagnosis offers a new and innovative era in microbial diagnosis, improving the speed and accuracy of identifying infectious diseases. It enables targeted therapy and timely interventions, leading to better patient outcomes.










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29 Nov
Categories Diseases, Genetics, Gynecology and obstetrics, speciality

Minagene’s Preimplantation Genetic Testing










Overview


Minagene offers comprehensive preimplantation genetic testing (PGT) utilizing next-generation sequencing and advanced bioinformatics. PGT screens embryos for aneuploidies (PGT-A), monogenic disorders (PGT-M), and structural rearrangements (PGT-S) to select the most euploid, mutation-free embryos for uterine transfer.


Methodology



Blastocyst biopsy


Blastocyst biopsy on day 5 post-fertilization maximizes trophectoderm sampling without compromising development. Whole genome amplification and massively parallel sequencing precisely genotype all 24 chromosomes and interrogate pathogenic mutations at >20,000X coverage. Proprietary algorithms minimize artifacts to assure diagnostic accuracy.


Trophectoderm biopsy on day 5 maximizes both viable cell cohort and developmental synchrony for accurate results, safely avoiding risk to the inner cell mass. This enhances live birth rates better than earlier biopsies.


Why Screening is Critical


Aneuploidy is the leading


Aneuploidy is the leading cause of implantation failure and miscarriage. Without PGT, embryos transferred harbor an up to 75% risk of chromosome abnormalities undetectable by morphology alone. Screening identifies the healthiest embryos most likely to achieve live birth.


Why preimplantation genetic testing?


PGT optimizes ART


PGT optimizes ART success by selecting euploid embryos not carrying specific familial gene mutations for transfer. This alleviates repeated IVF cycles, miscarriages, termination of affected pregnancies, and liveborn offspring requiring lifelong care for genetic diseases.


Highlights of Minagene's preimplantation genetic testing (PGT)


Minagene’s PGT detects all 24 chromosome aneuploidies as well as over 1500 single gene disorders. It resolves structural variants and screens for unmatched maternal contamination with exact precision.


When to Consider Minagene’s preimplantation genetic testing (PGT)


Minagene’s preimplantation genetic



  •  Couples undergoing IVF

  •  Patients at any age who have had repeated implantation failure or recurrent pregnancy loss while undergoing IVF

  •  Women over 35 years old undergoing IVF

  •  Couples with recurrent miscarriages

  •  Positive history of chromosomal abnormalities in the family

  •  Diagnosed carriers of chromosomal aberrations

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20 Nov
Categories Diseases, Gynecology and obstetrics, speciality

Minagene’s NIPT Advanced Test










Overview


Minagene's NIPT Advanced utilizes massively parallel next-generation sequencing and advanced bioinformatics to perform comprehensive non-invasive prenatal testing via analysis of cell-free fetal-derived circulating cell-free DNA from maternal peripheral blood. Beyond conventional NIPT, it facilitates multi-dimensional genomic profiling
to enable detection of both common and rare autosomal aneuploidies, unbalanced chromosomal rearrangements, and pathogenic copy number variants.


Methodology



Unique molecular identifier-based


Unique molecular identifier-based sequencing of circulating cfDNA at ≥30X depth of coverage allows for whole-genome haplotype construction and improved variant resolution. Proprietary algorithms leveraging Bayesian likelihood ratios evaluated against comprehensive genome-wide genotype and phenotype databases achieve precise risk estimation for aneuploidies encompassing all autosomes, sex chromosomes, mitochondrial disorders, and pathogenic CNVs ≥3Mb.


Key Highlights of Minagene's Advanced NIPT


Comprehensive Fetal Genome Analysis:



  • Screens for rare autosomal aneuploidies undetected by standard NIPT

  • Identifies incidental findings such as pathogenic homozygous/hemizygous CNVs

  • Addresses scenarios requiring assessment of uniparental disomy or triallelic inheritance

  • Provides results within a short period accompanied by genetic counseling from board-certified specialists

  • Presents a safe alternative to invasive testing when abnormal ultrasound findings or elevated risk profiles warrant advanced prenatal diagnosis


When to consider Minagene’s Advanced NIPT


When to consider Minagene’s Advanced NIPT


Minagene’s NIPT Advanced Test is indicated for high-risk patients such as those with positive family histories, advanced maternal age, abnormal ultrasonography findings, history of recurrent pregnancy loss, or carrier status of translocations. It represents a definitive frontline examination when definitive diagnosis of sizable fetal genomic imbalances is imperative.

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