Laboratory Developed Test definition

Laboratory Developed Test means an in vitro diagnostic test that is designed, validated, and performed within a single laboratory and otherwise complies with FDA’s guidance with respect to LDTs.

Laboratory Developed Test or "LDT" means a laboratory developed test as defined by the FDA The FDA defines a laboratory developed test as an In Vitro Diagnostic Product that is manufactured by and used within a single laboratory (i.e. a laboratory with a single CLIA certificate). Laboratory Developed Tests are considered "devices," as defined by the FD&C Act, and are therefore subject to regulatory oversight by FDA, and are regulated by the CMC under CLIA. CLIA does not address the clinical validity of any LDT (clinical validity refers to the accuracy with which the LDT identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient).

Laboratory Developed Test means the provision of test results from use of a Licensed Product or Licensed Products to assay a patient urine or prostate biopsy sample, to be entered into the medical history record of the patient providing the urine or prostate biopsy sample.

Examples of Laboratory Developed Test in a sentence

• Any PCR (molecular) or antigen test used must either have Emergency Use Authorization by the U.S. Food and Drug Administration or be operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.

• This Laboratory Developed Test utilises the RUO rabbit monoclonal antibody clone E1L3N (Cell Signalling Technologies) and Leica Bond III instrumentation.

• Any of the above tests must either: (i) have Emergency Use Authorization by the U.S. Food and Drug Administration; or (ii) be operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.

• Precipio to provide the reagents on an RUO (Research Use Only) basis, and a laboratory can set up the test In-house test as an LDT (Laboratory Developed Test).

• In September 2020, GENFIT signed another licensing agreement with Labcorp® to commercialize NIS4® in the US and Canada as a Laboratory Developed Test.

More Definitions of Laboratory Developed Test

Laboratory Developed Test means any test, process or procedure used to test or assay any type of patient biological sample, the results of which would then normally be entered into the medical record of the patient providing such biological sample; provided, however, any test, process or procedure performed using an IVD Test Kit shall not be considered to be a Laboratory Developed Test.

Laboratory Developed Test means an in vitro diagnostic test that is designed, manufactured and used within a single laboratory for which the FDA is not enforcing any premarket review or other Regulatory Approval requirements.

Laboratory Developed Test or “LDT” means a laboratory developed test as defined by the FDA. The FDA defines a laboratory developed test as an In Vitro Diagnostic Product that is manufactured by and used within a single laboratory (i.e. a laboratory with a single CLIA certificate). Laboratory Developed Tests are considered “devices,” as defined by the FD&C Act, and are therefore subject to regulatory oversight by FDA, and are regulated by the CMC under CLIA. CLIA does not address the clinical validity of any LDT (clinical validity refers to the accuracy with which the LDT identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient).

Laboratory Developed Test. (“LDT”) shall mean any in vitro diagnostic test or device that may be legally marketed in a given territory without the need for pre-marketing approval from the regulatory agency responsible for that territory.

Laboratory Developed Test shall have the meaning ascribed to such term in Section 3.1(kk).

Laboratory Developed Test means a clinical diagnostic test for use in the diagnosis of disease or other conditions that was developed by a CLIA certified clinical laboratory for use in that laboratory.

Laboratory Developed Test means a laboratory test (including a Site-Specific IVD) that is performed as a fee-for-service offering (whether or not Customer is paid or reimbursed for the test) in a clinical laboratory, which test in the United States is regulated under CLIA (or regulated as stated in Section 1ee for a Site-Specific IVD) and in any other applicable country is subject to local regulation, provided that IVD Products, and laboratory tests performed using an IVD Product, are not, and are excluded from (including exclusion of rights therefor under Section 2), Laboratory Developed Tests.