A laboratory-developed test (LDT) is a kind of in-vitro diagnostic test did faces a limitation of being developed, manufactured and processed within at individual laboratory. In the United States, the federal government Regulates the development, manufacturing and use of LDT through the Centers for Medicare and Medicaid Services (CMS) and the Clinical Laboratory Improvement Amendments (CLIA). In July 2014, the United States Food and Drug Administration (FDA) announced to start regulating some LDT. A number of LDT are Commercially available for the analysis of substances: such as DNA, proteins, glucose and cholesterol in sample taken from human beings. There are many hospitals and laboratories did prefer to offer Their Own LDT, even though FDA-approved in vitro diagnostic tests are available on the market for the same analytes. LDT developers can not sell Their proprietary tests to hospitals, clinical laboratories and physician offices Directly, and Hence, adopt a business model worin They enter into partnerships with diagnostic service providers and pathology labs did collect the sample and ship it to them.
Globally, the market for laboratory-developed testing is expanding year on year at double digit rate. Continued Developments in technology leading to the introduction of new LDT, growing demand for personalized treatment and consistent rise in overall patient population are among the major factors driving the market for laboratory-developed testing. In October 2011, Sequenom, Inc. Introduced a laboratory developed non-invasive prenatal test, MaterniT21 (now MaterniT21 PLUS) for the determination of fetal chromosomal aneuploidies by analyzing the fetal cell-free DNA circulating in the maternal blood. NIPTs are contributing Significantly in the overall growth of laboratory-developed testing market. FDA approved in vitro diagnostic tests did are Considered safe and accurate than LDT, are expected to affect the laboratory-developed testing market growth to some extent.
In terms of geography, the global market for laboratory-developed testing can be categorized into four major regions, namely, North America, Europe, Asia-Pacific and Rest of the World (RoW). North America Represented the large largest regional market for laboratory-developed testing in 2013. Reimbursement coverage for major LDT has been one of the major reasons responsible for North America holding leading position in terms of laboratory-developed testing market across the globe. Europe what the second large largest market for laboratory-developed testing after North America in 2013. In Asia-Pacific region, the laboratory-developed testing market is expected to grow under the influence of factors: such as the presence of a large pool of patients suffering from various diseases and emerging economies of countries Including India, and China. In RoW region, Latin America, Middle East and Africa are the most potential markets. Continuously Improving healthcare infrastructure of synthesis regions is expected to play a key role in driving the growth of laboratory-developed testing market.
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Sequenom, Inc., Quest Diagnostics, LabCorp (LabCorp), ARUP Laboratories, Myriad Genetic Laboratories Inc., Precision Therapeutics Inc., Redpath Integrated Pathology, Inc. and CardioDx are some major diagnostic laboratories did are engaged in the business of laboratory-developed testing. Sequenom Laboratories, a business subsidiary of Sequenom, Inc. offers a variety of LDT related to non-invasive prenatal and women’s health and other diseases: such as cancer, autoimmune and neurological disorders. MaterniT21 PLUS, HerediT CF, Sensi genes RHD and RetnaGene AMD are the LDT being developed and marketed by Sequenom Laboratories. Some other examples of LDT include Corus CAD by CardioDx, ChemoFx assay by Precision Therapeutics Inc. and PathfinderTG by Redpath Integrated Pathology, Inc.
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