NAMSA IVD-Specific Expertise:

  • Blood glucose
  • Hemoglobin A1c
  • Urinalysis strips
  • Fusion protein (BCR-ABL)
  • Troponin
  • Stem Cell Enumeration (CD34+, CD45+)
  • Drugs of abuse
  • Therapeutic drug monitoring (theophylline, phenobarbital, dilantin)
  • Thyroid hormones
  • Bone alkaline phosphatase
  • Deoxypyridinoline and pyridinoline
  • Luteinizing Hormone (LH)
  • Human Chorionic Gonadotropin (HCG)
  • Streptococcus A
  • HIV
  • HLA Typing (DNA sequencing)
  • Cystic Fibrosis
  • UTI–uropathogen detection
  • Theophylline
  • Phenobarbital
  • Dilantin
  • hCG
  • Therapeutic Expertise
  • Oncology
  • Anemia
  • Reproductive
  • Cardiovascular
  • Allergy
  • Adrenal/Pituitary
  • Bone Metabolism
  • Autoimmune
  • Diabetes
  • Therapeutic Drug Monitoring
  • Endocrine
  • Infectious Disease
  • Fetal Well Being Therapeutic Expertise
  • Molecular Diagnostics
  • ELISA
  • Automated Instrumentation
  • Immunoassay
  • Immunohistochemistry
  • Calibrators
  • Controls Intended Uses
  • Diagnostic
  • Research Use Only
  • Point of Care
  • Quantitative
  • Qualitative
  • Semi-Quantitative
  • Companion Diagnostic for melanoma and lung cancers
  • Pre-IDE coordination and package development
  • FDA and CLIA Waiver submission
  • Studies using leftover de-identified samples as well as prospective studies requiring informed consent

NAMSA Project-Specific Examples: 

  • Immunoassay kit for detection of sepsis
  • Early-stage regulatory support to include study design, statistical analysis plan and pre-IDE interactions with FDA
  • Prognostic assays for breast, colon and prostate cancers with companion therapies
  • Assist global manufacturer with strategic commercialization planning, including U.S. and international regulatory requirements, resource planning and timelines
  • Assay for tissue typing
  • Full clinical trial support for large U.S. manufacturer, including project management, resource planning, site selection and qualification, monitoring, data management, biostatistics and report writing
  • Immunological assays for prostate, breast and colon cancer
  • Provide regulatory counsel and FDA interaction support for European manufacturer
  • Immunological and molecular diagnostics for us in in vitro fertilization
  • Assist global manufacturer with strategic commercialization planning to include regulatory affairs, resource estimation and timelines
  • Blood-based assay for screening of colon cancer
  • Provided regulatory counsel to venture capital group on likelihood, requirements and merits of FDA IVD vs. CLIA pathways
  • Filed BLA efficacy supplement for blood group reagents
  • Immunological assay to detect neurodegenerative disease
  • Assist European manufacturer with indicators for use, regulatory pathway and FDA interactions
  • Flow cytometry for stem cell enumeration Immunohistochemistry assay to detect prostate cancer, 26 monoclonal antibody-based blood grouping reagents, 2 anti-human globulin products, 13 reagent red blood cell products and supplements to 3 previously licensed reagents Instrument and DNA primers for K-RAS mutation detection kit Point-of-care test for counting blood cells and quantifying hemoglobin content
  • Regulatory assessment on modifications to blood cell analyzer
  • Assay to detect marker response to a drug therapy
  • HgB A1C point-of-care device
  • Immunohistochemistry assay to detect breast cancer
  • Genetic marker to detect human papillomavirus (HPV)
  • Regulatory assessment
  • Molecular genetics assay to detect cystic fibrosis
  • Cell separation product
  • CLIA waiver
  • Genetic screening for congenital indication
  • Breath sensor array device for detection of lung cancer
  • Reagents for immunoassay analyzer — chemistry assays, hormone level assays, etc.
  • Reagent panel for ABO typing
  • Cancer tissue marker
  • Hepatitis diagnostic

Why Choose NAMSA?

  • Regulatory, quality systems and assurance, data management, statistics, and clinical expertise all under one roof;
  • Proven working relationships with IRBs, Central Laboratories and sites for IVD studies;
  • Understanding of the various global regulations as they apply to IVD clinical trials and regulatory submissions;
  • Work with pharma and device companies on companion diagnostics;
  • Frequent contact with FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR);
  • Experience with instrument platforms, systems and database interfaces;
  • Staff includes members with prior laboratory experience (e.g. medical technologists, laboratory management and logistics expertise); and
  • Expertise with studies using leftover de-identified samples and prospective studies requiring informed consent, as well as studies where well- characterized banked samples are utilized.

Additional Experience with IVD & Companion Diagnosticss:

  • Pre-Submission meeting preparation and attendance
  • U.S. Regulatory submissions (IDE, 510(k), PMA, HUD, HDE, BLA, Device Master File)
  • FDA panel preparation and participation
  • International Submissions (Ethics Committee, Technical File, Dossier, STED) and Registrations (EU, Canada, Australia, Japan, BRIC and more)
  • U.S. Agent
  • Clinical Evaluation Reports
  • IVD Analytical Testing
  • NAMSA now performs IVD analytical testing per CLSI guidelines
  • Quality Systems
  • Development and implementation
  • Audits and gap analyses
  • Document control process
  • Design controls
  • Supplier audits
  • BIMO Inspection preparation and participation
  • Clinical study design and protocol development
  • Qualification and selection of clinical sites and core and central labs
  • Clinical study and site management
  • Monitoring of clinical data
  • Uploading instrument data outputs in lieu of manual data entry for data collection
  • Data management and statistical analysis for development of the clinical study report
  • Writing of clinical reports
  • Custom kit assembly including bar coding
  • Chain of Custody tracking of shipments nationally and internationally
  • Knowledgeable in area of IATA regulations
  • Experience managing ground and Next Flight Out (NFO) couriers
  • Logistical support for time sensitive testing of samples to central laboratories for therapeutic drug monitoring studies
  • Data management – Instrument data can be directly into the database via CD/jump-drive or electronic upload through our Electronic Data
  • Capture (EDC) solutions, reducing or eliminating the need for monitoring of a transcript to source
  • Expertise in XML, HL7, CSV and ASCII file formats and solutions for high volume upload
  • Experience developing clinical databases for data management tailored to IVD studies (and longitudinal patient data, when required)
  • FDA mandated post-market studies
  • Registries and retrospective studies
  • Health Economics studies
  • Post-market surveillance
  • Literature based meta-analysis