Overview


Minagene's Non-Small Cell Lung Cancer (NSCLC) Panel is a specialized genetic test designed to provide comprehensive genetic information for precise diagnosis, prognosis, and personalized treatment selection in patients with NSCLC. This panel utilizes cutting-edge next-generation sequencing (NGS) technology to analyze key genes and genetic alterations associated with NSCLC, enabling clinicians to make informed treatment decisions and optimize patient outcomes.


Methodology



The NSCLC Panel


The NSCLC Panel utilizes NGS-based targeted sequencing to analyze DNA or RNA extracted from tumor samples of NSCLC patients. The panel covers a wide range of genes known to be involved in NSCLC development and progression, including driver mutations, gene fusions, copy number variations (CNVs), and other genetic alterations. By assessing the genetic landscape of NSCLC, the panel provides a comprehensive genetic profile that guides personalized management strategies.


Key Highlights of the Test:


Key Highlights of the Test:


-Comprehensive Genetic Evaluation: The NSCLC Panel offers a comprehensive evaluation of genetic alterations associated with NSCLC. It analyzes key genes involved in NSCLC development, including EGFR, ALK, ROS1, KRAS, BRAF, and many others, allowing for a detailed genetic profile of the tumor. This information aids in accurate diagnosis, subtyping, and identification of potential therapeutic targets.


-Personalized Treatment Selection: By identifying actionable genetic alterations, the panel facilitates personalized treatment selection. It helps identify patients who are likely to benefit from targeted therapies, immunotherapies, or clinical trials based on their specific genetic profile. This approach improves treatment response rates and overall patient outcomes.


-Prognostic Insights: The NSCLC Panel provides valuable prognostic insights by assessing genetic alterations associated with disease aggressiveness and patient prognosis. The identification of high-risk genetic markers guides clinicians in tailoring treatment strategies, including the intensity and duration of therapy, to optimize patient outcomes.


-Resistance Mechanism Detection: The panel aids in detecting genetic alterations associated with resistance to targeted therapies commonly used in NSCLC. By identifying these resistance mechanisms, clinicians can make timely treatment adjustments, explore alternative treatment options, or consider combination therapies to overcome drug resistance.


-Monitoring Treatment Response: Serial analysis using the NSCLC Panel enables the monitoring of treatment response over time. By tracking changes in the genetic profile, clinicians can assess treatment efficacy, detect emerging resistance mechanisms, and guide treatment modifications for optimal disease control.


When to Consider This Test:


-NSCLC Diagnosis: The NSCLC Panel is recommended for patients with suspected or newly diagnosed NSCLC. It aids in precise diagnosis, subtyping, and identification of genetic alterations that guide treatment decisions.


-Treatment Decision-Making: The test assists in 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.


-Prognostic Assessment: The panel provides prognostic information by assessing genetic alterations associated with disease aggressiveness and patient prognosis. This information helps clinicians in risk stratification and treatment planning.


-Resistance Mechanism Detection: The panel aids in detecting genetic alterations associated with resistance to targeted therapies. It guides treatment adjustments and exploration of alternative treatment options to overcome drug resistance.


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










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










Overview


Minagene's testing utilizes targeted next-generation sequencing and immunohistochemistry to detect key driver mutations, fusions and immune biomarkers in lung adenocarcinoma, squamous cell carcinoma and small cell lung cancer specimens.


Methodology



DNA and RNA


DNA and RNA isolated from formalin-fixed paraffin-embedded biopsy/resection samples undergo hybrid capture-based enrichment of over 300 lung cancer-associated genes and loci. Simultaneous protein analysis assesses PD-L1 expression levels.


Key Highlights of Minagene’s Molecular Testing for Lung Cancer


Key Highlights of Minagene’s Molecular Testing for Lung Cancer


-Identifies EGFR, ALK, ROS1, BRAF, KRAS mutations for targeted therapy


-Detects rare MET, RET, HER2 alterations with matched drugs


-Determines tumor mutation burden and microsatellite instability status


-Assesses PD-L1 to predict response to immune checkpoint inhibitors


-Guides clinical trial enrollment and combinatorial treatment strategies


By applying an integrated genomic and protein-based approach, physicians can select optimal first-line and subsequent lines of targeted and immune therapies tailored to each patient’s molecular profile.


When to Consider Minagene’s Molecular Testing for Lung Cancer


Molecular testing should be ordered on all newly diagnosed lung cancers or at progression to optimize precision treatment planning based on actionable genomic alterations.










Overview


Minagene's test utilizes targeted next-generation sequencing and array-based platforms to comprehensively detect somatic mutations, chromosomal rearrangements, and gene expression signatures in leukemia, lymphoma and myeloma specimens.


Methodology



DNA and RNA


DNA and RNA are extracted from bone marrow, peripheral blood or tissue samples and processed for hybrid capture-based targeted sequencing of over 300 genes recurrently implicated in hematological cancers. Custom FISH/aCGH panels interrogate recurring translocations.


Key Highlights of Minagene’s Molecular Testing for Hematological Malignancies


Key Highlights of Minagene’s Molecular Testing for Hematological Malignancies


-Establishes definitive diagnoses for ambiguous morphologies


-Determines prognostic risk stratification and subtype classification


-Identifies targets for specific small molecule inhibitors and immunotherapies


-Monitors for minimal residual disease during and after treatment


-Features a CLIA-certified, CAP-accredited laboratory


By applying a multimodal genomic approach, clinicians can optimize therapeutic strategies from diagnosis through remission monitoring. Comprehensive mutational profiling assists clinical decision-making at all stages of care.


When to Consider Minagene’s Molecular Testing for Hematological Malignancies


Physicians should order Minagene’s molecular testing at initial workup of suspected hematological cancers as well as during surveillance and relapse to elucidate resistance mechanisms, guide clinical trial selection, and personalize management.










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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