The Development of New Diagnostic Tests for Neurologic Disorders in the Commercial Laboratory Environment
| Autor: | Stanley J. Naides, Iswariya Venkataraman |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
business.industry Clinical Laboratory Techniques Biochemistry (medical) Clinical Biochemistry Market size Diagnostic test Reproducibility of Results Outsourced Services Outsourcing medicine Humans Regulatory agency Nervous System Diseases Intensive care medicine business Laboratories Healthcare providers Market acceptance Reimbursement Biomarkers |
| Zdroj: | Clinics in laboratory medicine. 40(3) |
| ISSN: | 1557-9832 |
| Popis: | Development of new diagnostic tests in a commercial laboratory for neurologic disorders is challenging. Development occurs in a highly regulated environment. Relevant research infrastructure may not be readily available in-house and may require outsourcing with additional management and costs. Clinically characterized specimens for validation of biomarkers for esoteric diseases may be difficult to acquire, and market size may be difficult to predict. More common diseases with heterogeneous subsets may require better clinical definition. Absence of guidelines may delay health provider acceptance of novel testing. Regulatory agency approval and categorization of tests affects validation requirements and impacts market acceptance and reimbursement. |
| Databáze: | OpenAIRE |
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