Laboratory-developed tests (LDTs) are known as a type of in vitro diagnostic test. Lab-developed tests are designed, manufactured, and used within a single lab. Testing developed in the laboratory is considered a testing service developed in clinical laboratories, hospitals, and academic institutions according to proprietary procedures.
Laboratory-developed tests are often created to meet unmet clinical needs. Laboratory-developed tests are basically used to diagnose, monitor, and guide the treatment of patients early and accurately. It is also used to diagnose and access diseases and disorders for which FDA approval kits are not available.
Tests developed in the laboratory are used only within the laboratory as they are not licensed for sale or distribution to medical facilities or other laboratories. Clinical laboratories are currently regulated by the Medicare and Medicaid Service Center (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and will be changed by the US FDA’s regulatory framework over the next few years.
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The global laboratory development test market is divided based on test type and facility type-
Based on test type
- Clinical biochemistry
- Molecular diagnostics
- Immunology
- Critical care
- Microbiology
- Hematology
- others
Based on the type of facility
- Hospital Research Institute
- Professional diagnostic center
- Clinical research institute
- Academic institution
- others
The global laboratory development test market is expected to register significant CAGRs over the forecast period. The lack of access to rare disease-specific tests such as genetic and molecular tests is expected to boost the global market for laboratory-developed tests.
Changes to the test are required at the laboratory level, as existing tests may not apply to a particular disease. It is also expected to drive the testing market developed in laboratories around the world. Increasing funding for R & D activities for the diagnosis of rare and rare diseases by various regulators and some state governments is also expected to boost the growth of the global laboratory development testing market.
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However, the high cost of laboratory-developed tests due to the high cost of reagents and devices can hinder the growth of the global laboratory development test market. Delays in regulatory guidance for laboratory development trials by the US Food and Drug Administration (FDA) can also hinder the growth of the global laboratory development testing market.
The lack of skilled personnel to perform tests developed in specialized laboratories can also curb the growth of the global laboratory development test market over a forecast period.
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