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

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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

Price Point Analysis for Laboratory Developed Tests (LDTs) and FDA Regulated TestsExecutive SummaryResearch ScopeExecutive SummaryExecutive Summary (continued)Executive Summary (continued)Research Objectives AbbreviationsAutoimmune DiseasesCeliac Disease Specific LDT AssaysChron’s Disease Specific LDT AssaysRheumatoid Arthritis Specific LDT AssaysLupus Specific LDT AssaysLupusSpecific LDT Assays (continued)IBD and IBS Specific LDT AssaysBiomarker GuidelinesCardiologyCardiac Disease Specific LDTs and FDA AssaysCardiac Disease Specific LDTs and FDA Assays (continued)OncologyProstate Cancer Specific LDT AssaysProstate Cancer Specific LDT Assays (continued)Breast Cancer Specific LDT AssaysBreast Cancer Specific LDT Assays (continued)Breast Cancer Specific LDT Assays (continued)Colon Cancer Specific LDT and CLIA Waived AssaysColon Cancer Specific LDT and CLIA Waived Assays (continued)Colon Cancer Specific LDT and CLIA Waived Assays (continued)Lung Cancer Specific LDT and FDA AssaysLung Cancer Specific LDT and FDA Assays (continued)Gynecologic Cancers (Ovarian)Specific LDT and FDA AssaysGynecologic Cancers (Cervical)Specific LDT and FDA AssaysBiomarker GuidelinesGastric Cancer/GIST Specific LDT and FDA AssaysOther AreasWomen’s Health Vitamin D TestsWomen’s Health Prenatal TestsWomen’s Health Pregnancy and Hormone TestsToxicology Popularly Ordered TestsInfectious Diseases Popularly Ordered Genetic TestsInfectious Diseases Popularly Ordered Tests Legal DisclaimerThe Frost & Sullivan StoryThe Frost & Sullivan StoryValue Proposition—Future of Your Company & CareerGlobal PerspectiveIndustry Convergence360º Research PerspectiveImplementation ExcellenceOur Blue Ocean Strategy




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