Case Study – Flow Cytometry

Case Study – Flow Cytometry

Flow Cytometry

Case Study

Unusual Acute Promyelocytic Leukemia, reflexed for FISH analysis; t(15;17) positive.

  • Histogram 1: Promyelocytes isolated by SSC v CD45
  • Histogram 2: CD34 negative/CD117 positive promyelocytes (expected)
  • Histogram 3: CD11b negative (expected), HLA DR positive (unusual). The specimen was reflexed for PML/RARA fusion by fluorescence in situ hybridization and was positive.
Comprehensive Panels
Samples are received and processed by experienced laboratory personnel per established, validated protocols and guidelines. Screening antibody panels for all sample types are designed to reliably detect abnormal populations. The comprehensive panel includes markers for adequate characterization of all cell lines. Additional testing, as indicated, may be used to further and fully characterize any abnormal cells detected.
Unique Approach to Data Analysis
Many laboratories use basic analysis techniques and provide pathologists with pre-printed histograms; this approach, although common, is less than optimal. At MPLN, the raw (list mode) data is independently analyzed by a hematopathologist with experience at a level not routinely offered by other laboratories. After sample processing and appropriate quality review with respect to sample, reagent and instrument parameters, the list mode data is analyzed by the hematopathologist. Previous patient results, history and clinical information are incorporated in the analysis, and possible ancillary testing (FISH, cytogenetics, molecular, etc.) is considered.
Case Study - Flow Cytometry
In-Depth Report
The report is designed to convey clinically relevant information in an easy to read format. The findings address sample quality, sample cellularity, and quantitation and characterization of all major cell lines. When present, abnormal populations are clearly described, including cell type, percentage of involvement, cell size, and immunophenotypic features. The interpretation is written to address clinically relevant issues based on the provided information, previous studies at MPLN, and dialogue with the submitting physician. Ancillary testing is discussed with the client, when indicated, to maximize clinical information from the submitted sample.
Communication with Hematopathologist
A hematopathologist is available to discuss any questions related to hematopathology samples. Additionally, we welcome suggestions to help us improve our service, and we actively seek suggestions to help achieve our goal of providing accurate, reliable and clinically relevant data in a timely fashion. If you want to discuss any of the above topics or specific results, feel free to call.

    Project Management

    Our project managers have strong scientific backgrounds and extensive experience in complex research-based clinical trials. They collaborate with our scientific operations, client services, and commercial operations teams to deliver high-quality, regulatory-compliant testing results on time at every project step.

    Key Features

    • Each study is assigned a dedicated and experienced project manager
    • Studies are typically set up within 6 to 8 weeks of contract signature
    • Project management software tools ensure timely deliveries
    • Onsite customer service teams efficiently resolve queries and deliver reports

    Benefits

    • Accelerated study setup time
    • Responsive communication with the scientific and operational team
    • Testing completed on time and within budget
    • Prompt reporting of critical study data

    Data Management

    The key to a successful clinical trial is accurate, clean, quality data. Our team of data managers provides you with data in customized formats exported to your data management teams from our in-house laboratory information system (LIS).

    Key Features

    • Access to dedicated and experienced data specialists upon contract award
    • Customized reports are agreed upon in study-specific data transfer agreement
    • In-house software development team for custom data solutions
    • Flexible data exports and data transfers

    Benefits

    • Real-time reports for your data and project teams to aid in patient management
    • Guaranteed data integrity and quality
    • Improved decision-making and enhanced patient safety
    • Timely access to accurate, clean data for intermediate or final database lock
    Genomic Solutions

    Genomic Solutions

    Genomic medicine, a vital tool in oncology and drug development by providing deeper, more personalized insights into each patient.
    Beyond informing drug target discovery, validation, and clinical development, it uncovers critical genetic markers that drive disease progression and influence individual treatment responses. This empowers healthcare professionals to create more precise, tailored treatment plans, optimizing medical management based on each patient’s unique genetic profile.

    DNA Solutions – WGS*, WGMS*, WES*, TSO-500 Comp, Pillar OncoReveal
    RNA Solutions – Total RNA-Seq*, RNA exome*, mRNA*
    Liquid Biopsy Solutions – TSO-500 ctDNA, PGDx elio™ plasma complete*

    Key Features

    • Targeted NGS panels, including FDA-approved assays with companion diagnostic designations
    • Customized bioinformatics and reporting solutions 
    • Robust assay designs to accommodate low-yielding biopsy material
    • Streamlined wet lab processes to meet screening window timelines

    Benefits

    • Identify variants along with key biomarker signatures
    • Save time and money by assessing multiple biomarkers in a single test
    • Enable targeted therapies with actionable, easy-to-interpret results
    • Assists in targeted patient stratification and recruitment
    • Accelerates the development of personalized medicine

    *Offered through fully accredited partner laboratories.
    Digital Pathology

    Digital Pathology

    Digital pathology revolutionizes clinical trials by enhancing accessibility, cost-efficiency, compliance, and data management. MPLN’s comprehensive digital pathology services streamline clinical research, allowing for improved patient outcomes and operational efficiency.

    Features:

    • Seamless access to digital slides and slide retrieval enables instant access to digital slides.
    • Cost-effective digital slide management streamlines logistics by reducing the need for physical slide storage and transportation.
    • Digital storage ensures slides remain in perfect condition over time.

    Benefits:

    • Allows key opinion leaders (KOL) and remote client pathologists to be utilized
    • Digital slides can be easily shared, allowing for faster, more collaborative decisions, including obtaining second opinions.
    • Reduces the costs associated with physical storage and transport of slides, improving trial efficiency.
    • Simplifies regulatory processes, ensuring quicker and more accurate FDA submissions and audit readiness.
    • Prevents slide degradation or breakage, maintaining the quality of research data for the long term.
    • Enables broader patient recruitment by facilitating decentralized clinical trials for wider geographic participation, increasing patient recruitment and diversity.
    Global Logistics

    Global Logistics

    Effective global logistics are the cornerstone of effective specialty laboratory testing supporting global clinical trials. With precious patient samples such as biopsy and bone marrow aspirates, ensuring samples reach the lab on time and within stability is paramount.

    Key Features

    • Partnerships with global specialist couriers and large integrators to support global studies and specialty shipping requirements
    • Ambient, refrigerated, frozen, and liquid nitrogen storage and shipment services available
    • Real-time or batched shipments based on your clinical trial’s individual needs
    • Secure, high-volume, redundant data storage solutions for digital pathology images
    • Expert advice for effective sample collection, handling, and transport
    • Accurate tracking and inventory for all clinical trial specimens

    Benefits

    • Safe and effective transport of specimens worldwide
    • Standardized procedures to reduce pre-analytical variability and ensure valid results
    • Centralized and harmonized specialty pathology testing supported
    • Reduced costs and maximized budgets with fully managed logistics from one trusted source
    • Readily available inventories, manifests, and shipments for timely study closeouts
    Multiplex IHC

    IHC & Multiplex IHC

    Our advanced technology enables simultaneous visualization of single or multiple biomarkers within the same tissue section, delivering comprehensive insights and precise diagnostics. With unmatched expertise and cutting-edge technology, our team supports you in understanding complex tissue microenvironments, aiding patient stratification and treatment response prediction.

    Features:

    • Simultaneously visualize multiple biomarkers within the same tissue section for deeper insights.
    • Advanced analysis of tissue microenvironments to assist in patient stratification and treatment response prediction.
    • Custom assay design and flexible testing to meet your unique research or clinical trial needs.
    • Detailed data analysis and interpretation are provided by our expert team to ensure accurate results.

    Benefits:

    • Allows enhanced information from small biopsy samples. (I.e. NSCLC)
    • Gain comprehensive insights that lead to more precise diagnostics and better patient outcomes.
    • Enhanced ability to identify patient subgroups and better predict treatment responses with greater accuracy.
    • Whether in biomarker discovery or clinical trials, our advanced technology supports a range of applications, helping you unlock the full potential of your tissue samples.
    Cytogenetics FISH

    Cytogenetics & FISH

    We offer a comprehensive range of chromosome analysis and fluorescent in situ hybridization (FISH) testing with industry-leading turnaround times and global coverage. Our board-certified lab directors and experienced cytogenetic technologists ensure accurate, efficient, and competitively priced testing with the highest quality of service.

    Features:

    • Extensive FISH menu of over 40 loci and disease-specific panels detecting gene amplifications, deletions, translocations, and inversions.
    • Testing is available on bone marrow, blood, and FFPE tissue samples.
    • Specialized Offerings:
      • Plasma cell enrichment for plasma disorders
      • Stat turnaround for PML::RARA and acute myeloid leukemia
      • Bladder cancer urine analysis
      • Custom FISH assay development
    • Comprehensive chromosome analysis testing for oncology, infertility, recurrent pregnancy loss, and congenital disorders.
    • Global coverage of equivocal CAP/CLIA services supporting clinical trials

    Benefits:

    • Rapid, precise results critical for diagnosis and treatment.
    • Expert-driven testing with Board-certified experts ensures the highest accuracy.
    • Tailored assays and solutions to meet unique clinical needs.
    • Faster diagnostics support timely treatment decisions.