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

  • ID: 3876772
  • Report
  • September 2016
  • Region: Global, United States
  • 52 Pages
  • Frost & Sullivan
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Discover the Perfect Assay Price Point to Remain Competitive
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.
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1 Executive Summary
  • Research Scope
  • Executive Summary
  • Research Objectives
  • Abbreviations
2 Autoimmune Diseases
  • Celiac Disease Specific LDT Assays
  • Chron’s Disease Specific LDT Assays
  • Rheumatoid Arthritis Specific LDT Assays
  • Lupus Specific LDT Assays
  • IBD and IBS Specific LDT Assays
  • Biomarker Guidelines
3 Cardiology
  • Cardiac Disease Specific LDTs and FDA Assays
4 Oncology
  • Prostate Cancer Specific LDT Assays
  • Breast Cancer Specific LDT Assays
  • Colon Cancer Specific LDT and CLIA Waived Assays
  • Lung Cancer Specific LDT and FDA Assays
  • Gynecologic Cancers (Ovarian)Specific LDT and FDA Assays
  • Gynecologic Cancers (Cervical)Specific LDT and FDA Assays
  • Biomarker Guidelines
  • Gastric Cancer/GIST Specific LDT and FDA Assays
5 Other Areas
  • Women’s Health Vitamin D Tests
  • Women’s Health Prenatal Tests
  • Women’s Health Pregnancy and Hormone Tests
  • Toxicology Popularly Ordered Tests
  • Infectious Diseases Popularly Ordered Genetic Tests
  • Infectious Diseases Popularly Ordered Tests
  • Legal Disclaimer
6 The Publisher's Story
  • Value Proposition-Future of Your Company & Career
  • Global Perspective
  • Industry Convergence
  • 360º Research Perspective
  • Implementation Excellence
  • Our Blue Ocean Strategy
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