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Myelodysplastic Syndromes Global Support

Myelodysplastic Syndromes Global Support

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

      Recent Posts

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      Data Management at Geneuity

      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 8 to 12 weeks of contract signature
        • Project management software tools ensure timely deliveries
        • On-site customer service teams efficiently resolve queries and deliver reports

        Benefits

        • Accelerated study setup time
        • Responsive communication with the scientific and operational teams
        • 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 the 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 testing delivers powerful, patient-specific insights that guide precision oncology and inform the next generation of targeted therapies.

        Our genomic testing options uncover 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 genetic profile[click here to view testing options].

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

        Key Features

        • Targeted NGS panels, including FDA-approved assays with companion diagnostic designations
        • Customized bioinformatics and reporting solutions.
        • Robust assay 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.

        Key Features

        • A cloud-based image management platform provides seamless access to digital images from anywhere in the world
        • Validated diagnostic workflows for primary diagnosis
        • Digital imaging workflows that streamline logistics and reduce the need for physical slide storage and transportation
        • Digital image transfer services and long-term secure image storage options are available

        Benefits

        • Allows key opinion leaders (KOL) and remote client pathologists to be utilized in clinical trial workflows
        • Enables efficient centralized review with simultaneous pathologist viewing
        • Reduces the costs associated with physical slidetransport and storage
        • Simplifies regulatory processes, ensuring faster and more accurate FDA submissions and audit readiness
        • Prevents slide degradation or breakage, maintaining the quality of research data in 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.

        Key Features

        • Over 200 IHC antibodies validated and ready for use in clinical trials [click here to view our IHC test menu]
        • Custom assay validation and flexible testing to meet unique research or clinical trial needs
        • Simultaneous visualization of multiple biomarkers within the same tissue section
        • Board-certified pathologists provide detailed data analysis and interpretation to ensure accurate results

        Benefits

        • Gain comprehensive insights that lead to more precise diagnostics and better patient outcomes
        • Enhanced ability to identify patient subgroups and better predict treatment responses
        • Maximize information from small biopsy samples (i.e. NSCLC)
        • 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.

        Specialized Offerings:

        • Plasma cell enrichment for plasma disorders
        • Stat turnaround for PML::RARA and acute myeloid leukemia
        • Bladder cancer urine analysis
        • Custom FISH assay validation services

        Key Features

        • Extensive FISH menu of over 40 loci and disease-specific panels detecting gene amplifications, deletions, translocations, and inversions [click here to view testing menu]
        • Testing is available on bone marrow, blood, and FFPE tissue samples
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        • Fully harmonized services at accredited partner labs to support global clinical trials

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        • Rapid, precise results that are critical for diagnosis and treatment
        • Achieve comprehensive coverage for key genes indicated in the diagnosis and prognosis of hematological malignancies per the current WHO, NCCN, and ELN guidelines
        • Expert-driven testing, conducted by board-certified experts, ensures the highest accuracy
        • Tailored assays and solutions to meet unique clinical trial needs
        • Faster diagnostics to support timely treatment decisions