Universal Newborn Screening - Are We Ready for the Leap?
What is NBS?
Newborn Screening is a test designed to screen the infants for a list of conditions right after the birth. It includes testing for metabolic disorders at the time of birth, which includes Fatty Acid Oxidation Disorders, Organic Acid Disorders, Amino Acid Disorders, Hormonal Tests, Haemoglobinopathies and Hearing. Newborn screening is generally done by taking a few drops of blood from the baby's heel 24 to 48 hours after birth.
WHO Report
Causes of 2.761 million deaths during the neonatal period in 2013, worldwide
Out of 4.3 million babies born annually in the US, 98 percent were screened for various inherited conditions. A few years ago, limited tests were included in the panel, Phenylketonuria, Galactosemia, Maple Syrup Urine Disease, Homocystinuria, Biotinidase deficiency, Sickle cell disease, Hypothyroidism, and Congenital Adrenal Hyperplasia were considered important. Advancements in the technology opened doors to increase in the number of disorders tested. EnLite Neonatal TREC Kit, is the first screening test and is legalized to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns in December, 2014. Tandem mass spectrometry is a major instrument used for newborn screening. In the last decade, introduction of tandem mass spectrometry has become a compulsory public health strategy in most developed and developing countries. The panel of test may vary from country to country. The main drivers include funding from the government, advancement in the technology.
Emerging economies:
Asia Pacific region is expected to grow as a new revenue for the newborn screening market in the coming years. PerkinElmer signed an exclusive three year newborn screening program in China with National Health and Family Planning Commission of China in 2014. As a company, with its advanced technologies, it is training doctors, clinicians, and lab technicians across rural counties and in overall program management. Japan and Taiwan, the NBS program is an ongoing process. In Philippines, The Newborn Screening Reference Center (NSRC) gives technical assistance to the Filipino newborns.
In India, out of 25 million new born, approximately 1.6 million babies are born with deficiencies. It is facing pressure to develop screening and the developments for a universal screening have been in very slow process. States like Goa, Kerala and Gujarat have already introduced newborn screening funded by their government. However, the main restrains could be trained personnel for result interpretation, expensive treatments and are for life long, budget issues, ethical issues, false negative and false positive results, follow-up tests for the positive results.
NBS is successful program in the North America and Europe. In our country, NBS may become important with the rising economy, growing access to the technology and many companies focusing on this market. There are a number of private firms looking for opportunity on different types of screening tests. A task force is needed for to spread NBS awareness not only in the public but also to the physicians and the lab technicians. Organizations like International Society for Neonatal Screening, World Association of Perinatal Medicine and March of Dimes should help in implementing the NBS program in the developing countries.
Newborn Screening is a test designed to screen the infants for a list of conditions right after the birth. It includes testing for metabolic disorders at the time of birth, which includes Fatty Acid Oxidation Disorders, Organic Acid Disorders, Amino Acid Disorders, Hormonal Tests, Haemoglobinopathies and Hearing. Newborn screening is generally done by taking a few drops of blood from the baby's heel 24 to 48 hours after birth.
WHO Report
Causes of 2.761 million deaths during the neonatal period in 2013, worldwide
Out of 4.3 million babies born annually in the US, 98 percent were screened for various inherited conditions. A few years ago, limited tests were included in the panel, Phenylketonuria, Galactosemia, Maple Syrup Urine Disease, Homocystinuria, Biotinidase deficiency, Sickle cell disease, Hypothyroidism, and Congenital Adrenal Hyperplasia were considered important. Advancements in the technology opened doors to increase in the number of disorders tested. EnLite Neonatal TREC Kit, is the first screening test and is legalized to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns in December, 2014. Tandem mass spectrometry is a major instrument used for newborn screening. In the last decade, introduction of tandem mass spectrometry has become a compulsory public health strategy in most developed and developing countries. The panel of test may vary from country to country. The main drivers include funding from the government, advancement in the technology.
Emerging economies:
Asia Pacific region is expected to grow as a new revenue for the newborn screening market in the coming years. PerkinElmer signed an exclusive three year newborn screening program in China with National Health and Family Planning Commission of China in 2014. As a company, with its advanced technologies, it is training doctors, clinicians, and lab technicians across rural counties and in overall program management. Japan and Taiwan, the NBS program is an ongoing process. In Philippines, The Newborn Screening Reference Center (NSRC) gives technical assistance to the Filipino newborns.
In India, out of 25 million new born, approximately 1.6 million babies are born with deficiencies. It is facing pressure to develop screening and the developments for a universal screening have been in very slow process. States like Goa, Kerala and Gujarat have already introduced newborn screening funded by their government. However, the main restrains could be trained personnel for result interpretation, expensive treatments and are for life long, budget issues, ethical issues, false negative and false positive results, follow-up tests for the positive results.
NBS is successful program in the North America and Europe. In our country, NBS may become important with the rising economy, growing access to the technology and many companies focusing on this market. There are a number of private firms looking for opportunity on different types of screening tests. A task force is needed for to spread NBS awareness not only in the public but also to the physicians and the lab technicians. Organizations like International Society for Neonatal Screening, World Association of Perinatal Medicine and March of Dimes should help in implementing the NBS program in the developing countries.
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