Myelodysplastic Syndromes Global Support

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Myelodysplastic Syndromes Global Support

  • Biopharma, Multiplex Immunohistochemistry
H&E BM

For myelodysplastic syndromes, current therapy is selected based on risk, transfusion needs, percent of bone marrow blasts, cytogenetic and mutational profiles, comorbidities, potential for allogeneic stem cell transplantation (alloSCT), and prior exposure to hypomethylating agents (HMA).

Better diagnosis and prognostic stratification may allow a more precise and personalized treatment of MDS with novel agent combinations, leading to improved therapeutic algorithms. 

Here at MPLN-Genuity, we have combined our decades of diagnostic expertise and understanding of disease mechanisms with our enhanced global capability to prepare a comprehensive suite of CAP/CLIA and ISO 15189 analytical methods. 

This global testing will assist clinical teams and biopharma companies in their drug development projects to implement a refined cytogenetic and molecular assessment of MDS that could improve prognostic stratification and patient monitoring with the integration of clinical, hematological, and genomic data.

MPLN's worldwide support network
MPLN's worldwide support network
H&E BM
H&E BM
CD71 BM
CD71 BM

Myelodysplastic Syndrome Analytical Methods

    • Global Centralized Bone Marrow aspirate assessment by hematopathologist 

         

          • Pathologist Bone Marrow Evaluation (Aspirate), (BMA) inclusive of Iron and Wright Giemsa stain reads.

      • Global Centralized Bone Marrow Biopsy assessment by hematopathologists

           

            • Pathologist Bone Marrow Evaluation (BMB) 

            • includes evaluation and reporting of All IHC stains.

            • Cellularity and megakaryocytic dysplasia.

            • With inclusive additional IHC workup as requested and agreed with the client 

            • CD34, CD71, CD117, MPO , CD42b

        • Regionalized Complex Karyotyping and reporting. 

        • USA, EMEA, APAC,  

        • A central report issued by MPLN/Geneuity 

        • Globalized DNA extraction and Myeloid Panel NGS 

        • Myeloid Sequencing Panel. 

        • Panel contents vary on discussion with the Client.

        • Mutations most often seen in MDS cells include those in the DNMT3A, TET2, ASXL1, TP53, RUNX1, SRSF2, and SF3B1

      Wright Giemsa BMA
      Wright Giemsa BMA
      Deletion 5q female k-type
      Deletion 5q female k-type

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      Contact us now to see how we can support your next MDS trial.
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      Jonathan Mulkey November 8, 2024

      Effective data management is crucial in the fast-paced world of clinical trials. At MPLN, our journey through data management has evolved significantly since our first clinical trial in 2004.

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        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

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        *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.
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        • 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 clinical trial services

        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 - clinical trial services

        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.
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        • Rapid, precise results critical for diagnosis and treatment.
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