TAG:
Esoteric testing
Esoteric testing allows the analysis of rare substances or molecules that are not performed in a routine clinical lab. Many large commercial lab companies outsource complex tests to reference and esoteric testing labs. However, as technology continues to expand laboratory testing, tests that are considered esoteric today may become routine in just a few years. This is often the result of work performed by dedicated research and development scientists.
These tests are ordered when a physician requires additional detailed information, outside routine lab testing, to complete a diagnosis, establish a prognosis or choose and monitor a therapeutic regimen. Esoteric testing generally requires sophisticated instruments and materials as well as specialized personnel to perform and analyze results. The tests are typically outsourced to independent, specialized clinical reference laboratories because it is not cost effective for hospitals and physician office laboratories to perform the tests in-house.
These tests are ordered less frequently than routine tests and are generally priced higher than the routine tests. Esoteric testing is typically related to the medical fields such as endocrinology, genetics, immunology, microbiology, molecular diagnostics, oncology, serology and toxicology. Molecular diagnostics is the fastest growing segment of esoteric clinical testing.
The American Chemical Society publishes the Directory of Rare Analyses (DORA) which catalogues rarely ordered clinical tests and provides details on the labs performing them.
The challenges for labs performing such tests include not only finding qualified medical technologists, but also paying them the higher salaries they command because of the scarcity of their skill sets. In addition, materials used in these tests can also be costly, particularly because they are not usually purchased in large enough quantities to qualify for economies of scale.
Labs that perform these tests have capabilities including:
• Allergy
• Complex anatomic pathology with board-certified pathologist
• Bone markers
• Genetic analysis
• HLA testing
• Functional assays of the immune system
• Toxicology
In the U.S., labs that perform these tests range from ARUP Laboratories, Mayo Medical Laboratories, Quest Diagnostics Incorporated, and Laboratory Corporation of America to a growing number of specialty esoteric testing laboratories that offer proprietary esoteric assays. Examples of such specialty testing lab companies include Myriad Genetics, Genomic Health, and Foundation Medicine.
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Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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