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Licenses / Accreditations

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Licenses / Accreditations

MPLN is a CLIA-certified medical laboratory authorized in all fifty states, including New York (NYSDOH), California, and Maryland, which also require state licensure alongside CLIA. 

CAP Accredited
CAP Accredited
MPLN is accredited by the College of American Pathologists (CAP) and has met the standards for laboratory accreditation of the CAP Laboratory Accreditation Program.
ISO 15189 Certified
ISO 15189 Certified
Certificate 3765.01

MPLN is accredited by A2LA in accordance with the standard ISO 15189:2012 Medical Laboratories for technical competence in the field of clinical testing.

CLIA Certified - Clinical Laboratory Improvement Amendments
CLIA Certified

MPLN is a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory and has met all standards for quality control, personnel qualifications, and laboratory facilities.

National Provider Identifier

1053335729

MPLN CAP
Expires August 04, 2027

New York State Permit
Expires June 30, 2026

State of California License

Expires December 25, 2026

TN DoH License
Expires January 31, 2026

ISO 15189 Certificate 
Expires May 31, 2027

State of Maryland License
Never expires

MPLN CLIA
Expires March 07, 2026

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    Cytogenetics FISH - clinical trial services

    KOL Network

    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.
    CONNECT WITH AN EXPERT TODAY

    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
    • Comprehensive chromosome analysis testing for oncology, infertility, recurrent pregnancy loss, and congenital disorders
    • Fully harmonized services at accredited partner labs to support global clinical trials

    Benefits:

    • 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
    Central Pathology Expertise

    Central Pathology Expertise

    Our multi-modal testing approach integrates components of pathology, molecular diagnostics, cytogenetics, FISH, immunohistochemistry, and flow cytometry, all aligned with clinical guidelines. Our team of expert pathologists delivers fully integrated diagnostic and central review services for global phase I-IV clinical trials.
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    We specialize in comprehensive diagnostics for heme malignancies and solid tumors. MPLN/Geneuity partners with a global network of pathologists to support a broad range of additional specialized areas (gastrointestinal, kidney, liver, urology, cytology, dermatopathology, and more).

    Key Features

    • Board-certified hematopathologists on staff to enable multiple independent reads, adjudication, and formal consensus review 
    • Extensive global network of specialty pathologists with centralized reporting  
    • Comprehensive diagnostic strategies aligned with the most current WHO, NCCN, and ELN guidelines 
    • Full support for diagnostic, patient management, and exploratory clinical trial endpoints 

    Benefits:

    • High-quality results driven by testing strategies anchored in  internationally recognized guidelines 
    • Deep clinical insights that strengthen patient care and enhance the success of regulatory submissions 
    • Uniform, high-integrity datasets generated through standardized global workflows and reporting systems 

    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
    CONNECT WITH AN EXPERT TODAY

    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.
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    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.

    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.
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    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.
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    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.

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    Key Features

    • Over 200 IHC antibodies validated and ready for use in clinical trials
    • 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.
    CONNECT WITH AN EXPERT TODAY
    VIEW TESTS

    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
    • Testing is available on bone marrow, blood, and FFPE tissue samples
    • Comprehensive chromosome analysis testing for oncology, infertility, recurrent pregnancy loss, and congenital disorders
    • Fully harmonized services at accredited partner labs to support global clinical trials

    Benefits:

    • 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