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Price Point Analysis for Laboratory Developed Tests (LDTs) and FDA Regulated Tests

Price Point Analysis for Laboratory Developed Tests (LDTs) and FDA Regulated Tests

The main objective of this research is to estimate test volumes and unit prices for a wide variety of LDTs (genetic) and a few high volume FDA tests for selective therapeutic areas. The tests are categorized by their intended uses across the diagnostic spectrum (risk assessment, screening, diagnosis, staging and prognosis, therapy selection, therapy monitoring). A selective list of therapeutic areas covered in this research include: autoimmune diseases, cancers (breast, colorectal, prostrate, lung, gastric, cervical, and ovarian), toxicology, cardiology, women’s health (vitamin D, prenatal, pregnancy and hormone), and infectious disease testing (TB, hepatitis A/B/C, cytomegalovirus). The base year used for analysis is 2015.


  • Executive Summary
    • Research Scope
    • Executive Summary
    • Research Objectives
    • Abbreviations
  • Autoimmune Diseases
    • Celiac Disease Specific LDT Assays
      • Table LDTs and FDA Regulated Test Markets: Celiac Disease, US, 2015
    • Chron's Disease Specific LDT Assays
      • Table LDTs and FDA Regulated Test Markets: Chron's Disease, US, 2015
    • Rheumatoid Arthritis Specific LDT Assays
      • Table LDTs and FDA Regulated Test Markets: Rheumatoid Arthritis, US, 2015
    • Lupus Specific LDT Assays
      • Table LDTs and FDA Regulated Test Markets: Lupus, US, 2015
    • IBD and IBS Specific LDT Assays
      • Table LDTs and FDA Regulated Test Markets: IBD and IBS, US, 2015
    • Biomarker Guidelines
  • Cardiology
    • Cardiac Disease Specific LDTs and FDA Assays
      • Table LDT and FDA Regulated Tests Market: Cardiac Disease, US, 2015
  • Oncology
    • Prostate Cancer Specific LDT Assays
      • Table LDTs and FDA Regulated Tests Market: Prostrate Cancer, US, 2015
    • Breast Cancer Specific LDT Assays
      • Table LDTs and FDA Regulated Tests Market: Breast Cancer, US, 2015
    • Colon Cancer Specific LDT and CLIA Waived Assays
      • Table LDTs and FDA Regulated Tests Market: Colon Cancer, US, 2015
    • Lung Cancer Specific LDT and FDA Assays
      • Table LDTs and FDA Regulated Tests Market: Lung Cancer, US, 2015
    • Gynecologic Cancers (Ovarian) Specific LDT and FDA Assays
      • Table LDTs and FDA Regulated Tests Market: Gynecologic Cancers (Ovarian), US, 2015
    • Gynecologic Cancers (Cervical) Specific LDT and FDA Assays
      • Table LDTs and FDA Regulated Tests Market: Gynecologic Cancers (Cervical), US, 2015
    • Biomarker Guidelines
    • Gastric Cancer/GIST Specific LDT and FDA Assays
      • Table LDTs and FDA Regulated Tests Market: Gastric Cancer/GIST, US, 2015
  • Other Areas
    • Women's Health Vitamin D Tests
      • Table LDTs and FDA Regulated Tests Market: Women's Health (Vitamin D), US, 2015
    • Women's Health Prenatal Tests
      • Table LDTs and FDA Regulated Tests Market: Women's Health (Prenatal) US, 2015
    • Women's Health Pregnancy and Hormone Tests
      • Table LDTs and FDA Regulated Tests Market: Women's Health (Pregnancy and Hormone) US, 2015
    • Toxicology Popularly Ordered Tests
      • Table LDTs and FDA Regulated Tests Market: Toxicology, US, 2015
    • Infectious Diseases Popularly Ordered Genetic Tests
      • Table LDTs and FDA Regulated Tests Market: Infectious Diseases (Genetic), US, 2015
    • Infectious Diseases Popularly Ordered Tests
      • Table LDTs and FDA Regulated Tests Market: Infectious Diseases, US, 2015

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