Molecular Pathology Laboratory Network, Inc. Selects HALO AP® to Deliver Comprehensive Reference Laboratory Services and Biopharma Laboratory Support

Molecular Pathology Laboratory Network, Inc. Selects HALO AP® to Deliver Comprehensive Reference Laboratory Services and Biopharma Laboratory Support

Myelofibrosis case with reticulin staining (left) and H&E (right). Molecular Pathology Laboratory Network

Indica Labs announced today that Molecular Pathology Laboratory Network, Inc. (MPLN), a leader in laboratory medicine, hematopathology, and solid tumor oncology testing, has selected the HALO AP® platform from Indica Labs to deliver digital pathology services to both clinical reference labs and biopharma clients. HALO AP® is now in the final stages of clinical validation in MPLN’s CAP/CLIA-certified laboratory, where it is being prepared for initial deployment as a laboratory developed test (LDT) in the setting of urothelial bladder cancer and myeloid neoplasms. Additional disease indications will be validated in HALO AP® as LDTs in a stepwise manner once the initial indications are fully deployed. 

HALO AP® is an AI-powered, pathologist-driven digital pathology platform that enables primary diagnosis and other routine workflows in anatomic pathology. The platform is CE-IVDR marked and has all the tools pathologists need to conduct accurate, standardized diagnostic evaluation in a future-ready environment capable of deploying off-the-shelf, third-party AI and image analysis tools. In addition, HALO AP® streamlines second opinion requests and consultations, and facilitates management of clinical trials within a unified platform.  

“With the deployment of HALO AP®, our in-house pathologists and those that are part of our key opinion leader (KOL) network in the US, EU, and APAC regions are able to easily collaborate on cases and perform centralized pathology assessment without the need to ship precious patient material at risk of damage or loss in transit. Our goal with digital pathology is to improve diagnostic efficiency while maintaining regulatory compliance and providing the highest standard of patient care. Real-time collaboration through digital pathology enables us to deliver diagnoses faster and eliminates disparate access to leading pathology experts, ultimately benefitting patient outcomes,”

said Dr. Ravyn Duncan, Vice President, Scientific Operations and Research of MPLN.

With MPLN’s dedication to advanced diagnostic testing, the addition of HALO AP® into their portfolio strengthens the commitment to patient care. HALO AP® deployment within a dedicated, secure cloud environment and integration with MPLN’s proprietary laboratory information system will streamline pathology services from accessioning through reporting. This will result in significant time savings achieved through reduced pathology processing, specimen handling, and simplified case review of thousands of slides each year. 

In addition to deploying HALO AP® for primary diagnosis, MPLN will also deploy the platform to comprehensively manage clinical trials for biopharma clients. Broadening access to digital pathology is a cost-effective solution for clinical trial sites around the globe, saving hundreds of thousands of dollars each year in specimen logistics. 

“Our scientific team has found the HALO AP® platform to be feature-rich and capable of fulfilling our digital pathology needs. Using HALO AP®, we aim to consolidate our second-opinion pathology reviews on a single, integrated digital pathology system that provides consistent, high-quality image management and distribution. We are excited to explore using the HALO AP® platform further, using HALO AI in hematopathology applications to develop complex analysis algorithms and streamline workflows,”

said Dr. Roger Hubbard, MPLN Chief Executive Officer.

“We’re excited to work with MPLN on implementing digital pathology workflows. The team will be well positioned for future expansion of their deployment to include AI-based image analysis, as HALO AP® can integrate any AI algorithm,”

said Eric Runde, Chief Operating Officer at Indica Labs.

HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP® is For Research Use Only in the USA and is not FDA-cleared for clinical diagnostic use. In addition, HALO AP® provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR. 

About Indica Labs

Indica Labs is the global leader in AI-powered digital pathology software and services. Our flagship HALO® and HALO AI platform revolutionizes quantitative evaluation of whole slide images. HALO Link provides collaborative image management while HALO AP® and HALO AP Dx deliver enterprise digital pathology for primary diagnosis with regulatory clearances in multiple markets. Through a commitment to open pathology, performance, scalability, and ease-of-use, we help pharma companies, diagnostic labs, hospitals, research organizations, and Indica’s own Cloud and Pharma Services make discoveries and diagnoses that transform patient care and scientific discovery.    

Original article: https://www.pathologynews.com/industry-news/molecular-pathology-laboratory-network-inc-selects-halo-ap-to-deliver-comprehensive-reference-laboratory-services-and-biopharma-laboratory-support-2/

    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 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

    • 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

    • 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

    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

    • 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.
    • Our expert team provides detailed data analysis and interpretation 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 more accurately.
    • 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.
    • 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.