Laboratory developed test (LDT) is known as a type of in-vitro diagnostic test. Laboratory developed test is designed, manufactured and used within a single laboratory. Laboratory developed test is considered as testing services developed in clinical laboratories, hospitals, and academic institutes according to their own procedures.
The laboratory developed test is often created in response to unfulfilled clinical needs. Laboratory developed test is basically used for early and precise diagnosis, monitoring and guiding the treatment of the patient. It is also used to diagnose and access the diseases and disorders for which the FDA approved kits are not available.
The laboratory-developed test are used solely within the laboratory as it’s not allowed to sold or distributed to healthcare facilities or other labs. Currently, the clinical laboratories are regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and are expected to change by the U.S. FDA regulatory framework in upcoming years.
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The global laboratory development test market is segmented on the basis of test type and type of facility-
On the basis of test type
- Clinical Biochemistry
- Molecular Diagnostics
- Critical Care
On the basis of type of facility
- Hospitals laboratory
- Specialty Diagnostic Centers
- Clinical Research organizations
- Academic Institutes
The global laboratory development test market is expected to register a significant CAGR over a forecast period. The non-availability of specialized tests for rare diseases such as genetic tests and molecular tests is expected to boost the global market of laboratory developed test.
Sometimes the existing test may not apply to a particular disorder, and so modification of the test is required at the lab level which also anticipated to propel the global laboratory developed test market. The increasing funding for the research and development activities for diagnosis of rare diseases and disorders by the various regulatory authority bodies and some state governments, also expected to fuel the growth of the global laboratory development test market.
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However, the higher cost of laboratory developed test due to high cost of reagents and devices, may hamper the growth of the global laboratory development test market. The delay by the U.S. Food and Drug Administration (FDA) for the regulatory guidance on laboratory-developed tests, may also hinder the growth of the global laboratory development test market.
The lack of skilled personnel to perform the specialized laboratory-developed test may also restrain the growth of the global laboratory development test market over a forecast period.
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