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Women’s Health

Women's Health

MPLN has been providing molecular diagnostic testing for HPV, chlamydia (CT), and gonorrhea (NG) for over thirty years. Due to its extensive participation in clinical trials related to sexually transmitted infections (STIs), the laboratory has access to the latest technological advances and automation. We share these advancements with our clients to enhance their services.

Liquid Cytology Testing

Test from a single liquid cytology specimen
(ThinPrep® PAP solution or SurePath™ Test Pack) for:

  • Chlamydia trachomatis (CT)
  • Neisseria gonorrhoeae (NG)
  • Human papillomavirus (HPV) and HPV genotyping (HPV G)
  • Trichomonas vaginalis (TV)
  • Herpes simplex virus (HSV)

Visit the CDC’s site for more information on the prevalence of STDs: www.cdc.gov/std

Aptima Trichomonas Vaginalis Assay

  • First FDA-cleared amplified nucleic acid test available to detect Trichomonas vaginalis
  • Requires a fraction of one organism for detection vs. the 10,000 organisms required for wet mount microscopy
  • Detects up to 100% of all Trichomonas infections
  • Available for use in both symptomatic and
    asymptomatic women

APTIMA® Combo 2/HPV/Trichomonas

Higher sensitivity, greater specificity:

  • FDA-cleared to detect Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NC)
  • Second generation test eliminates inhibition and cross-reactivity problems and minimizes equivocal results.
  • Three technologies: target capture, transcription-mediated amplification, and dual kinetic assay

Aptima HPV Assay

Provides enhanced testing, refined results, and offers
the following benefits:

  • FDA approved to detect 14 high-risk types of human papillomavirus (HPV)
  • Based on a clinical evaluation of more than 10,000 U.S. women with normal cytology results, the APTIMA® HPV Assay demonstrated superior clinical specificity and sensitivity with 24% fewer false positives compared to competitor FDA approved DNA tests
  • Fewer false positives translates to fewer unnecessary colposcopies.

Hologic Gen-Probe APTIMA® HPV 16 18/45 Genotype Assay

  • Identifies the two most highly oncogenic and persistent high-risk HPV types known to cause high-grade cervical neoplasia
  • Facilitates risk-stratification of patients at greater risk for cervical disease in order to tailor care more appropriately
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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

    • Studies are typically set up within 8 to 12 weeks of contract signature

    Benefits

    • Responsive communication with the scientific and operational teams

    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
    • 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 OncoRevealSolid 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

    • Cloud-based image managementplatform allows seamless access to digital images from anywhere around the globe.
    • Validated diagnostic workflows for primary diagnosis.
    • Digital imageworkflowsthat streamlinelogistics 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 fasterand more accurate FDA submissions and audit readiness.
    • Prevents slide degradation or breakage, maintaining the quality of research datalong-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 ofmultiple 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.

    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.

    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

    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 with board-certified experts ensures the highest accuracy.
    • Tailored assays and solutions to meet unique clinical trial needs.
    • Faster diagnostics to support timely treatment decisions.