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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
  • Publish Date:September 2016

  • Number of Pages:52

  • Report ID:4182511

  • Format:PDF

  • Publisher:Frost & Sullivan

$ 1500


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.

Table of contents

Executive Summary
Research Scope
Executive Summary
Research Objectives

Autoimmune Diseases
Celiac Disease Specific LDT Assays
Chron's Disease Specific LDT Assays
Rheumatoid Arthritis Specific LDT Assays
Lupus Specific LDT Assays
LupusSpecific LDT Assays (continued)
IBD and IBS Specific LDT Assays
Biomarker Guidelines

Cardiac Disease Specific LDTs and FDA Assays

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

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

The Frost & Sullivan 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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