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

Discover the Perfect Assay Price Point to Remain Competitive
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Published: 12 Sep 2016

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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