Reason to develop a laboratory test:
(1) There is a clinical need.
(2) The test is not commercially available.
(3) The test is otherwise prohibitively expensive.
Problems with LDT:
(1) The test may be in regulatory limbo unless submitted to the FDA.
(2) An insurance company may refuse to reimburse the test.
(3) The cost of development and operation needs to be covered.
(4) There may not be any commercial controls.
(5) Proficiency testing may be nonexistent.
(6) The testing quality must be maintained during the life span of the test offering.
(7) There may be liability if a result is called into question.
(8) The need to retain all data related to the development and performance of the test.
