Biopharma Laboratory Support

With over twenty years of invaluable experience and more than 400 completed studies in Phase I-IV clinical trials, we pride ourselves on our unparalleled expertise and knowledge in biopharma laboratory services. We are committed to taking a unique and sophisticated approach to understanding disease mechanisms and effectively translating this into the unique requirements of each clinical trial. 

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Reference Laboratory Services

MPLN has been at the forefront of speciality reference laboratory services for over thirty-five years, excelling in pathology, hematopathology, molecular diagnostics, infectious disease testing, and women’s health. Our accredited reference laboratory, recognized by the College of American Pathologists (CAP), ISO 15189, and the New York State Department of Health (NYSDOH), is dedicated to delivering actionable, personalized results for better patient outcomes.

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Experience Our Difference.

OUR FOCUS is bringing innovative technology to patient care. Molecular Pathology Laboratory Network (MPLN) is a leader in laboratory medicine, hematopathology, solid tumor oncology, immunology, and women’s health. Since our inception in 1989, we have pioneered the application of molecular pathology techniques in diagnostic and clinical research applications. 

OUR APPROACH offers a unique understanding of the disease mechanism, integrating data from anatomic, cellular, and molecular investigations to provide physicians and clinical research teams with actionable information for patient monitoring and treatment decisions.

OUR COMMITMENT is that our CAP/CLIA & ISO 15189 accredited Global Laboratory Network will deliver high-quality data, maintain exceptional customer service, and provide project management and data management services, making us the ideal partner to support clinical patient management and advance your new therapeutic and IVD/CDx medical device projects.

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LIS Blue - Laboratory Information System

Our LIS Blue is a fast, easy-to-use, secure, and accessible laboratory information system developed using the latest web technology.

Visit lis.mplnet.com

Personalized Testing

Providing an expanding menu of molecular diagnostics, specialty anatomic pathology, flow cytometry, fluorescence in situ hybridization, and cytogenetic testing, MPLN is dedicated to providing superior diagnostic services to our clients in biopharma, pathology groups, hospitals, medical laboratories, and physician groups nationwide. With a patient-focused approach, we honor an obligation to provide:

  • High-quality, timely results
  • Cost-effective testing strategies
  • Personalized consultative testing services
  • Responsive and professional customer service
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    Project Management & Data Management

    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 manage
    • 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 responses to treatments. This empowers healthcare professionals to create more precise, tailored treatment plans, optimizing medical management based on each patient s unique genetic profile.

    Key features

    Targeted NGS panels
    • Pillar oncoReveal panel (48 Genes)
    • NGS: BRAF, KRAS, NRAS, EGFR, TP53 Mutation Analysis
    • IDH1/IDH2 Mutation Analysis
    • IgVH Somatic Hypermutation
    • MYD88 p.L265P Mutation
    • TSO 500 Comp FDA approved
    RNA solutions
    • Total RNA-Seq, RNA Exome, mRNA Stranded
    DNA solutions
    • WGS, WGMS, WES, TSO-500, PGDx elio™ tissue
    Liquid Biopsy solutions
    • TSO-500 ctDNA, PGDx elio™ plasma complete
    Customized bioinformatics and reporting

    Benefits

    • Identify DNA and RNA variants along with key biomarker signatures such as TMB (Tumor Mutational
      Burden) and MSI (Microsatellite Instability)
    • Save time and money by assessing multiple biomarkers in a single test
    • Enable targeted therapies and clinical trials with actionable, easy-to-interpret results
    • Liquid biopsies are minimally invasive, allowing for a more dynamic analysis of tumor cells
    • Assists in targeted patient stratification and recruitment
    • Accelerates the development of personalized medicine
    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
    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

    • Partner with global specialist couriers and large integrator
    • Ambient, refrigerated, frozen, and Liquid nitrogen shipment service
    • Fully managed service covering all steps from study setup to execution
    • Custom kit building to match protocol specification
    • Cost-effective bulk or real-time kit distribution to the site
    • Advice and guidance on all shipping regulations and customs documentation
    • Expert advice on guidance for effective sample collection
    • Advice and support to prepare and produce Lab Manuals

    Benefits

    • Safe and effective transport worldwide of crucial patient specimen
    • Extend the reach of your clinical trial patient population worldwide
    • Allow centralized and harmonized specialty pathology testing
    • Support and assist in the recruitment of patients in your clinical trials
    • Reduce pre-analytical variability and ensure valid results are reported
    • Improve data quality and support patient stratification and recruitment
    • Enable timely, informed decisions about participants to be made
    • Reduce costs and maximize your study budgets with fully managed logistics

    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.

    IHC and Multiplex IHC

    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.