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Newborn Screening: Developments In Screening Technologies

Newborn Screening: Developments In Screening Technologies

Newborn screening tests look for developmental, metabolic, and genetic disorders in infants. It allows steps to be taken before development of symptoms. Although, majority of these illnesses are very rare, they can be treated with early diagnosis. Newborn screening includes over 30 conditions and illnesses. Increasing awareness among parents for disease screening is a major factor driving newborn screening market growth. Furthermore, various government and non-government organizations are actively focused on offering better fetal and maternal care. For instance, in June 2018, the American Society of Hematology (ASH) led a campaign to fight sickle cell disease in Africa and urged governments, particularly in sub-Saharan Africa, to invest in newborn screening of the disease.

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Novel treatments, biomarkers, and technologies are expected to enable various diseases to be considered as potential candidates to be included in New Born Screening (NBS) programs. For instance, new treatments such as Hematopoietic Stem Cell Transplant (HSCT), Enzyme Replacement Therapy (ERT), and gene therapy and new pharmacological drugs have allowed autoimmune diseases to be considered as potential candidates to be included in NBS programs.

Manufacturer in the newborn screening market are focused on developing new test kits and devices in order to diagnose more diseases or disorders at birth. For instance, in February 2018, Sema4, a health information company offering advanced genomic testing, launched Sema4 Natalis, a supplemental newborn screening test designed to detect 193 childhood-onset diseases or disorders.

Furthermore, several governments are supporting manufacturers to develop new screening tests by relaxing regulations for manufacturing and marketing products. For instance, in February 2017, the U.S. FDA approved marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed to detect Fabry, Gaucher, Mucopolysaccharidosis Type I (MPS I), and Pompe. It is the first newborn screening test permitted to be marketed by the FDA for these disorders.

Furthermore, increasing incidence of hospital acquired diseases create an acute need for newborn screening. For instance, according to the Center for Disease Control and Prevention (CDC), in 2011, around one in every 25 infants was infected with at least one hospital acquired infections.

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Government initiatives to support screening of newborns is also a major factor driving the newborn screening market. For instance, CDC is working to harness the latest advances in science and technology so that more disorders can be identified accurately and treated quickly. In 2005, CDC established the Newborn Screening Translation Research Initiative (NSTRI) with the CDC Foundation. NSTRI works with corporate, academic, and foundation partners to assure the quality of research methods during both pilot studies and routine screening.

However, lack of consensus for screening is a major restraining factor for newborn screening market growth. There is little agreement among countries on which specific disorders should be included in NBS programs. Although some countries screen for only one Inherited Metabolic Disorders (IMD), others screen for over 30 conditions. For instance, according to the Nature Medicine Journal 2012 study, screening strategies in Europe vary between countries. Moreover, in some countries such as Belgium, Italy, and Spain, policy-making is decentralized to regions or provinces that have separate NBS programs.

Similar conditions are observed in the U.S. where one state may result in screening a different set of disorders compared to a neighboring state. This absence of agreement on screening tests is due to the lack of high-quality observational evidence for most disorders.

Furthermore, multiple challenges need to be confronted including false negative and false positive results of screening tests, inadequate information about the natural history of disease, limited access in some geographic areas to advanced technologies, and treatment of conditions with various phenotypes.

Major players operating in the global newborn screening market include, Agilent Technologies, AB SCIEX, Bio-Rad Laboratories, Covidien PLC, GE Life Sciences, Masimo Corporation, Natus Medical Inc., PerkinElmer Inc., and ZenTech S.A.

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Mohit Joshi
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