A laboratory-developed test (LDT) is a kind of in-vitro diagnostic test that faces a limitation of be-ing developed, manufactured and processed within an individual laboratory. In the United States, the federal government regulates the development, manufacturing and use of LDTs 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) an-nounced to start regulating some LDTs. A number of LDTs are commercially available for the anal-ysis of substances such as DNA, proteins, glucose and cholesterol in sample taken from human be-ings. There are many hospitals and laboratories that prefer to offer their own LDTs, even though FDA-approved in-vitro diagnostic tests are available on the market for the same analyte. LDT de-velopers cannot sell their proprietary tests to hospitals, clinical laboratories and physician offices di-rectly, and hence, adopt a business model wherein they enter into partnerships with diagnostic ser-vice providers and pathology labs that collect the sample and ship it to them.

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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 LDTs, growing demand for personalized treatment and consistent rise in overall patient population are among the major fac-tors driving the market for laboratory-developed testing. In October 2011, Sequenom, Inc. intro-duced 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 circulat-ing in the maternal blood. NIPTs are contributing significantly in the overall growth of laboratory-developed testing market. FDA approved in-vitro diagnostic tests that are considered safe and accu-rate than LDTs, are expected to affect the laboratory-developed testing market growth to some ex-tent.

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 largest regional market for laboratory-developed testing in 2013. Re-imbursement coverage for major LDTs 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 was the second 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 influ-ence of factors such as the presence of a large pool of patients suffering from various diseases and emerging economy 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 these regions is expected to play a key role in driving the growth of laboratory-developed testing market.

Sequenom, Inc., Quest Diagnostics, Laboratory Corporation of America Holdings (LabCorp), ARUP Laboratories, Myriad Genetic Laboratories Inc., Precision Therapeutics Inc., RedPath Inte-grated Pathology, Inc. and CardioDx are some major diagnostic laboratories that are engaged in the business of laboratory-developed testing. Sequenom Laboratories, a business subsidiary of Se-quenom, Inc. offers a variety of LDTs related to non-invasive prenatal and women’s health and oth-er diseases such as cancer, autoimmune and neurological disorders. MaterniT21 PLUS, HerediT CF, SensiGene RHD and RetnaGene AMD are the LDTs being developed and marketed by Sequenom Laboratories. Some other examples of LDTs include Corus CAD by CardioDx, ChemoFx assay by Precision Therapeutics Inc. and PathfinderTG by RedPath Integrated Pathology, Inc.


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