Laboratory-developed tests have been described by the US Food and Drug Administration (FDA) as an IVD that is intended for clinical use and designed, manufactured and used within a single laboratory.
LDTs have been defined as those in vitro diagnostic tests that are developed and used by a laboratory in a healthcare setting. The vast majority of LDTs are either not commercially available or have been developed in response to an unmet need.
Diagnostic testing, and interpreting those tests, is considered the practice of medicine. The FDA is not allowed to regulate the practice of medicine. Yet it is responsible for regulating medical devices. Diagnostic tests use machines, sample tubes, and other tools that are clearly medical devices.
Laboratory Developed Tests (LDTs) provide timely, accurate, quality testing for many conditions for which no commercial test exists or when an existing test does not meet current clinical needs.
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Top Key Players:
23andme, Inc., Adaptive Biotechnologies Corporation, Admera Health, Agendia Nv, Agilent Technologies Inc., Ambry Genetics Corp., BGI, Biodesix, Inc., Biotheranostics, Inc., Bruker Corporation, Caredx, Inc., Centogene Ag, Epic Sciences, Inc., Eurofins, Foundation Medicine, Inc., Guardant Health, Inc., Helix, Illumina, Inc., Invitae Corporation, Laboratory Corporation of America (Labcorp), LunglifeAI, MDXHealth, Myriad Genetics, Inc., Natera, Inc., Neogenomics, Opko Health, Inc./Opko Diagnostics, Pacific Biosciences of California, Inc., Perkin Elmer, Inc., Qiagen N.V., Quest Diagnostics, Roche Diagnostics, Rosetta Genomics Ltd., SCIEX Pte Ltd., Thermo Fisher Scientific, Inc., Waters Corporation
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Market Report Segment: by type
- Mass Spectrometry
Market Report Segment: by application
- Speciality Clinic
- Surgical Center
Market Report Segment: by region
- Asia Pacific
- North America
- South America
- Middle East & Africa
Besides, it offers full-house information of sellers including the profile, details of item, applications, yearly execution in the business, deals, income, ventures, acquisitions and mergers, advertise size, piece of the pie, and the sky is the limit from there. The report has made the worldwide business sector report with an inclusion of point by point diagram of the worldwide Laboratory Developed Tests (LDT) industry including worldwide creation deals, worldwide income, and CAGR.
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At the end, of the Laboratory Developed Tests (LDT) Market Professional Survey Report 2021 includes:- Methodology, Analyst Introduction and Statistics Supply. At long last, the examination contains Laboratory Developed Tests (LDT) SWOT investigation, venture partialness examination, speculation incorporate innovative work propensity examination.
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