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      Genomics Precision Diagnostic > Newborn Screening

      Newborn Screening

      Igenomix Newborn Screening is a genetic test that analyzes 237 genes linked to more than 200 conditions.

      • Technical Overview
      • Criteria & Clasification
      • Genes & Diseases
      • Documentation
      • Scientific evidence

      Diseases with presentation in
      infancy

      Conditions with serious clinical
      repercussions, affecting the
      development of the newborn

      POC Products of Conception

      Potentially treatable
      and actionable
      alterations

      Genetic disorders with
      sufficient medical knowledge
      and scientific evidence

      Interested in learning more?

      Request information
      Or Email us at supportspain@igenomix.com
      Genomics Precision Diagnostic > Newborn Screening

      Newborn Screening

      Igenomix Newborn Screening is a genetic test that analyzes 237 genes linked to more than 200 conditions.

      • Technical Overview
      • Criteria & Clasification
      • Genes & Diseases
      • Documentation
      • Scientific Evidence

      Diseases with presentation in
      infancy

      Conditions with serious clinical
      repercussions, affecting the
      development of the newborn

      POC Products of Conception

      Potentially treatable
      and actionable
      alterations

      Genetic disorders with
      sufficient medical knowledge
      and scientific evidence

      Interested in learning more?

      Request information
      Or Email us at supportspain@igenomix.com
      Overview
      • Newborn Screening
      • Benefits
      • Indications

      Overview

      • Around 3%-4% of newborns are affected by a genetic condition.
      • Igenomix NBS identifies genetic disorders in newborn babies.
      • Newborn screening is a mandatory public health program that offers screening and follow-up medical care to all newborns for a variety of medical conditions.
      • Igenomix Newborn Screening Test is a comprehensive genetic test that analyzes 237 genes using Next Generation Sequencing (NGS) technologies allowing a direct approach of genetic disorders to reach a rapid, accurate diagnosis.
      • In addition, this test identifies a child is a healthy carrier of any of these genetic alterations.

      NBS provides an extended panel of disorders analyzed with NGS based technologies offering a wider coverage than NBS done by the NHS.

      • These genes are responsible for developmental, genetic and metabolic disorders that cause serious health problems starting in early childhood.
      • The ultimate benefit is an early intervention to prevent intellectual and physical disabilities as well as life-threatening illnesses.
      • This test allows the detection of many more disorders than with a conventional heel prick test.
      Know more

      Goals of Conventional Newborn Screening (NBS)

      The goals of newborn screening are:

      • Decrease morbidity and mortality of actionable diseases by performing an early intervention to improve neonatal and long-term health outcomes.
      • Provide a universal health service of screening to all newborns.
      • Identifying screen-positive newborns
      • Diagnosing conditions
      • Communication with families
      • Referral to treatment centers
      • Follow up with long-term outcomes
      • Educating physicians and patients.

      What is the procedure?

      Benefits of Using NGS/Clinical Utility

      IGX uses Next Generation Sequencing (NGS) technologies to perform NBS vs tandem mass spectrometry (MS-MS).

      Benefits of using NGS:

      • High clinical utility, by detecting +200 diseases.
      • Detect potentially treatable genetic conditions.
      • Allows an early clinical intervention of the baby.
      • Can avoid the development of symptoms, some of which may be irreversible..
      • Option for additional analysis and diagnosis at any stage of life.
      • The addition of DNA-based testing to primary NBS allows the diagnosis of conditions that could not be previously identified with a laboratory marker, given the nature of the technologies used.
      • Since NGS-WES technologies are used for the analysis, the patient’s data will be saved for the option for additional analysis and diagnostics at any stage of life.
      • Supports reproductive decisions and family planning.
      • Scientific advice for doctors and genetic counselling for patients, before and after the test.
      • Results: 25 calendar days.

       Indication

      • It is a screening test of genetic actionable diseases indicated for all newborns.
      • Early treatment is crucial to prevent complications and improve the
        prognosis for newborns.

      Test Limitations

      • Newborn screening DOES NOT replace the potential value of carrier genetic testing (CGT) nor does carrier genetic testing replace newborn screening.
      • Performed during the first days of life.
      • Bucal swab.
      Criteria & Clasification

      What has been included and why?

      The disease included in the Newborn Screening have been selected given the following criteria:

      • Diseases with presentation in infancy.
      • Conditions with serious clinical repercussions, affecting the development of the newborn.
      • Potentially treatable and actionable alterations.
      • Genetic disorders with sufficient medical knowledge and scientific evidence.

      Igenomix Newborn Screening vs current NBS

      NBS test incorporates all diseases from conventional newborn screening (heel prick test).

      FAQs

      Opening hours, contact details, lab address...

      User manual

      Igenomix and fertility

      We work to make a world in which infertility is no longer an impossible barrier. Together with clinics and fertility specialists worldwide, we investigate human reproduction to change the lives of those who are trying to conceive.

      Learn more about Igenomix
      Genes & Diseases
      Gene List

      The diseases included in the Igenomix NBS test can be classified in the following groups. You can find an example of a disease included in each group and its management.


      Disease Group
      Disorder
      Signs and Symptoms
      Patient Management
      Result
      MetabolicMaple Syrup Urine DiseaseCharacterized by poor feeding, lethargy, vomiting, a maple syrup odor in the cerumen and urine, encephalopathy and central respiratory failure if untreated.Dietary therapy to reduce toxic metabolites and achieve plasma concentrations of missing amino acids.Asymptomatic normal life
      MetabolicMaple Syrup Urine DiseaseCharacterized by poor feeding, lethargy, vomiting, a maple syrup odor in the cerumen and urine, encephalopathy and central respiratory failure if untreated.Dietary therapy to reduce toxic metabolites and achieve plasma concentrations of missing amino acids.Asymptomatic normal life
      ImmunodeficiencySevere Combined Immunodeficiency (SCID)Presentation due to recurrent, increasingly severe infections with opportunistic organisms and failure to thrive.Protective measures of prophylaxis with antibiotics, antifungals, antivirals and antibody replacementReduce the incidence of infections, slowing the progression and improve prognosis.
      ImmunodeficiencySevere Combined Immunodeficiency (SCID)Presentation due to recurrent, increasingly severe infections with opportunistic organisms and failure to thrive.Protective measures of prophylaxis with antibiotics, antifungals, antivirals and antibody replacementReduce the incidence of infections, slowing the progression and improve prognosis.
      NeurologyWilson DiseasePatients presents with abdominal pain, jaundice, hepatosplenomegaly, ascites, upper gastrointestinal bleed and mental status changes.Early initiation of copper chelationReduce accumulation of copper and prevent irreversible damage.
      NeurologyWilson DiseasePatients presents with abdominal pain, jaundice, hepatosplenomegaly, ascites, upper gastrointestinal bleed and mental status changes.Early initiation of copper chelationReduce accumulation of copper and prevent irreversible damage.
      PulmonologyCystic FibrosisNewborns present with rectal prolapse, meconium ileus, respiratory infections, pancreatic insufficiency, failure to thrive among other symptomsEarly initiation of pulmonary therapy, nutritional therapy, antibiotic prophylaxis, vaccination, bronchodilatorsDecrease the incidence of infections, maintain pulmonary function. Reduce progression and improve prognosis
      PulmonologyCystic FibrosisNewborns present with rectal prolapse, meconium ileus, respiratory infections, pancreatic insufficiency, failure to thrive among other symptomsEarly initiation of pulmonary therapy, nutritional therapy, antibiotic prophylaxis, vaccination, bronchodilatorsDecrease the incidence of infections, maintain pulmonary function. Reduce progression and improve prognosis
      EndocrinologyCongenital hypothyroidismMost infants are asymptomatic, those with symptoms typically present with lethargy, hoarse cry, feeding problems, constipation, myxoedema, macroglossia, among others.Early initiation of thyroid hormone replacement (oral levothyroxine)Prevent the development of impaired neurocognitive outcome, measured by intelligence quotient (IQ)
      EndocrinologyCongenital hypothyroidismMost infants are asymptomatic, those with symptoms typically present with lethargy, hoarse cry, feeding problems, constipation, myxoedema, macroglossia, among others.Early initiation of thyroid hormone replacement (oral levothyroxine)Prevent the development of impaired neurocognitive outcome, measured by intelligence quotient (IQ)
      ENTHereditary Hearing Loss*Infants will most likely remain asymptomatic until early childhood where the patient will have trouble understanding words, hearing consonants, avoidance of social setting etcEarly initiation of hearing aids, speech therapy and language therapyPrevent developmental and speech delay
      ENTHereditary Hearing Loss*Infants will most likely remain asymptomatic until early childhood where the patient will have trouble understanding words, hearing consonants, avoidance of social setting etcEarly initiation of hearing aids, speech therapy and language therapyPrevent developmental and speech delay
      HemoglobinopathiesSickle cell anemiaNewborns can present with severe anemia, vaso-occlusive crisis, chronic abdominal pain, hyposplenism and infections.Early initiation of primary prevention of acute complications, as well as hematopoietic stem cell transplantationPrevent recurrent acute vaso-occlusive episodes and with successful hematopoietic stem cell transplantation achieve a normal asymptomatic life
      HemoglobinopathiesSickle cell anemiaNewborns can present with severe anemia, vaso-occlusive crisis, chronic abdominal pain, hyposplenism and infections.Early initiation of primary prevention of acute complications, as well as hematopoietic stem cell transplantationPrevent recurrent acute vaso-occlusive episodes and with successful hematopoietic stem cell transplantation achieve a normal asymptomatic life
      NeuromuscularSpinal Muscular AtrophyCharacterized by diffuse symmetric proximal muscle weakness greater in lower than upper extremities with absent or markedly decreased deep tendon reflexes.Early initiation of disease-modifying therapy and supportive therapyImprove quality of life and increase survival of affected individuals
      NeuromuscularSpinal Muscular AtrophyCharacterized by diffuse symmetric proximal muscle weakness greater in lower than upper extremities with absent or markedly decreased deep tendon reflexes.Early initiation of disease-modifying therapy and supportive therapyImprove quality of life and increase survival of affected individuals
      Documentation

      Clinical Sheet

      Download

      Brochure

      Download

      Gene List

      Download

      Report Guidelines

      Download
      Scientific evidence

      Relevant related studies:

      ACOG Committee Opinion No. 778 Summary: Newborn Screening and the Role of the Obstetrician–Gynecologist. (2019). Obstetrics & Gynecology, 133(5), 1073-1074. doi: 10.1097/aog.0000000000003246

      https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp/index.html#:~:text=The%20RUSP%20is%20a%20list,newborn%20screening%20(NBS)%20programs

      van Campen, Sollars, Thomas, Bartlett, Milano, & Parker et al. (2019). Next Generation Sequencing in Newborn Screening in the United Kingdom National Health Service. International Journal Of Neonatal Screening, 5(4), 40. doi: 10.3390/ijns5040040

      Adhikari, A. N., Gallagher, R. C., Wang, Y., Currier, R. J., Amatuni, G., Bassaganyas, L., Chen, F., Kundu, K., Kvale, M., Mooney, S. D., Nussbaum, R. L., Randi, S. S., Sanford, J., Shieh, J. T., Srinivasan, R., Sunderam, U., Tang, H., Vaka, D., Zou, Y., Koenig, B. A., … Brenner, S. E. (2020). The role of exome sequencing in newborn screening for inborn errors of metabolism. Nature medicine, 26(9), 1392–1397. https://doi.org/10.1038/s41591-020-0966-5

      Rajabi, F. (2018). Updates in Newborn Screening. Pediatric Annals, 47(5). doi: 10.3928/19382359-20180426-01

      Wang, W., Yang, J., Xue, J., Mu, W., Zhang, X., Wu, W., Xu, M., Gong, Y., Liu, Y., Zhang, Y., Xie, X., Gu, W., Bai, J., & Cram, D. S. (2019). A comprehensive multiplex PCR based exome-sequencing assay for rapid bloodspot confirmation of inborn errors of metabolism. BMC medical genetics, 20(1), 3. https://doi.org/10.1186/s12881-018-0731-5

      Waisbren, S., Bäck, D., Liu, C., Kalia, S., Ringer, S., Holm, I., & Green, R. (2014). Parents are interested in newborn genomic testing during the early postpartum period. Genetics In Medicine, 17(6), 501-504. doi: 10.1038/gim.2014.139 

      Pereira, S., Robinson, J. O., Gutierrez, A. M., Petersen, D. K., Hsu, R. L., Lee, C. H., Schwartz, T. S., Holm, I. A., Beggs, A. H., Green, R. C., McGuire, A. L., & BabySeq Project Group (2019). Perceived Benefits, Risks, and Utility of Newborn Genomic Sequencing in the BabySeq Project. Pediatrics, 143(Suppl 1), S6–S13. https://doi.org/10.1542/peds.2018-1099C

       

      Overview
      • Newborn Screening
      • Benefits
      • Indications

      Overview

      • Around 3%-4% of newborns are affected by a genetic condition.
      • Igenomix NBS identifies genetic disorders in newborn babies.
      • Newborn screening is a mandatory public health program that offers screening and follow-up medical care to all newborns for a variety of medical conditions.
      • Igenomix Newborn Screening Test is a comprehensive genetic test that analyzes 237 genes using Next Generation Sequencing (NGS) technologies allowing a direct approach of genetic disorders to reach a rapid, accurate diagnosis.
      • In addition, this test identifies a child is a healthy carrier of any of these genetic alterations.

      NBS provides an extended panel of disorders analyzed with NGS based technologies offering a wider coverage than NBS done by the NHS.

      • These genes are responsible for developmental, genetic and metabolic disorders that cause serious health problems starting in early childhood.
      • The ultimate benefit is an early intervention to prevent intellectual and physical disabilities as well as life-threatening illnesses.
      • This test allows the detection of many more disorders than with a conventional heel prick test.
      Know more

      Goals of Conventional Newborn Screening (NBS)

      The goals of newborn screening are:

      • Decrease morbidity and mortality of actionable diseases by performing an early intervention to improve neonatal and long-term health outcomes.
      • Provide a universal health service of screening to all newborns.
      • Identifying screen-positive newborns
      • Diagnosing conditions
      • Communication with families
      • Referral to treatment centers
      • Follow up with long-term outcomes
      • Educating physicians and patients.
      What is the procedure?

      Benefits of Using NGS/Clinical Utility

      IGX uses Next Generation Sequencing (NGS) technologies to perform NBS vs tandem mass spectrometry (MS-MS).

      Benefits of using NGS:

      • High clinical utility, by detecting +200 diseases.
      • Detect potentially treatable genetic conditions.
      • Allows an early clinical intervention of the baby.
      • Can avoid the development of symptoms, some of which may be irreversible..
      • Option for additional analysis and diagnosis at any stage of life.
      • The addition of DNA-based testing to primary NBS allows the diagnosis of conditions that could not be previously identified with a laboratory marker, given the nature of the technologies used.
      • Since NGS-WES technologies are used for the analysis, the patient’s data will be saved for the option for additional analysis and diagnostics at any stage of life.
      • Supports reproductive decisions and family planning.
      • Scientific advice for doctors and genetic counselling for patients, before and after the test.
      • Results: 25 calendar days.

       Indication

      • It is a screening test of genetic actionable diseases indicated for all newborns.
      • Early treatment is crucial to prevent complications and improve the
        prognosis for newborns.

      Test Limitations

      • Newborn screening DOES NOT replace the potential value of carrier genetic testing (CGT) nor does carrier genetic testing replace newborn screening.
      • Performed during the first days of life.
      • Bucal swab.
      Criteria & Clasification

      What has been included and why?

      The disease included in the Newborn Screening have been selected given the following criteria:

      • Diseases with presentation in infancy.
      • Conditions with serious clinical repercussions, affecting the development of the newborn.
      • Potentially treatable and actionable alterations.
      • Genetic disorders with sufficient medical knowledge and scientific evidence.

      Igenomix Newborn Screening vs current NBS

      NBS test incorporates all diseases from conventional newborn screening (heel prick test).

      Genes & Diseases
      Gene List

      Disease Group
      Disorder
      Signs and Symptoms
      Patient Management
      Result
      MetabolicMaple Syrup Urine DiseaseCharacterized by poor feeding, lethargy, vomiting, a maple syrup odor in the cerumen and urine, encephalopathy and central respiratory failure if untreated.Dietary therapy to reduce toxic metabolites and achieve plasma concentrations of missing amino acids.Asymptomatic normal life
      MetabolicMaple Syrup Urine DiseaseCharacterized by poor feeding, lethargy, vomiting, a maple syrup odor in the cerumen and urine, encephalopathy and central respiratory failure if untreated.Dietary therapy to reduce toxic metabolites and achieve plasma concentrations of missing amino acids.Asymptomatic normal life
      ImmunodeficiencySevere Combined Immunodeficiency (SCID)Presentation due to recurrent, increasingly severe infections with opportunistic organisms and failure to thrive.Protective measures of prophylaxis with antibiotics, antifungals, antivirals and antibody replacementReduce the incidence of infections, slowing the progression and improve prognosis.
      ImmunodeficiencySevere Combined Immunodeficiency (SCID)Presentation due to recurrent, increasingly severe infections with opportunistic organisms and failure to thrive.Protective measures of prophylaxis with antibiotics, antifungals, antivirals and antibody replacementReduce the incidence of infections, slowing the progression and improve prognosis.
      NeurologyWilson DiseasePatients presents with abdominal pain, jaundice, hepatosplenomegaly, ascites, upper gastrointestinal bleed and mental status changes.Early initiation of copper chelationReduce accumulation of copper and prevent irreversible damage.
      NeurologyWilson DiseasePatients presents with abdominal pain, jaundice, hepatosplenomegaly, ascites, upper gastrointestinal bleed and mental status changes.Early initiation of copper chelationReduce accumulation of copper and prevent irreversible damage.
      PulmonologyCystic FibrosisNewborns present with rectal prolapse, meconium ileus, respiratory infections, pancreatic insufficiency, failure to thrive among other symptomsEarly initiation of pulmonary therapy, nutritional therapy, antibiotic prophylaxis, vaccination, bronchodilatorsDecrease the incidence of infections, maintain pulmonary function. Reduce progression and improve prognosis
      PulmonologyCystic FibrosisNewborns present with rectal prolapse, meconium ileus, respiratory infections, pancreatic insufficiency, failure to thrive among other symptomsEarly initiation of pulmonary therapy, nutritional therapy, antibiotic prophylaxis, vaccination, bronchodilatorsDecrease the incidence of infections, maintain pulmonary function. Reduce progression and improve prognosis
      EndocrinologyCongenital hypothyroidismMost infants are asymptomatic, those with symptoms typically present with lethargy, hoarse cry, feeding problems, constipation, myxoedema, macroglossia, among others.Early initiation of thyroid hormone replacement (oral levothyroxine)Prevent the development of impaired neurocognitive outcome, measured by intelligence quotient (IQ)
      EndocrinologyCongenital hypothyroidismMost infants are asymptomatic, those with symptoms typically present with lethargy, hoarse cry, feeding problems, constipation, myxoedema, macroglossia, among others.Early initiation of thyroid hormone replacement (oral levothyroxine)Prevent the development of impaired neurocognitive outcome, measured by intelligence quotient (IQ)
      ENTHereditary Hearing Loss*Infants will most likely remain asymptomatic until early childhood where the patient will have trouble understanding words, hearing consonants, avoidance of social setting etcEarly initiation of hearing aids, speech therapy and language therapyPrevent developmental and speech delay
      ENTHereditary Hearing Loss*Infants will most likely remain asymptomatic until early childhood where the patient will have trouble understanding words, hearing consonants, avoidance of social setting etcEarly initiation of hearing aids, speech therapy and language therapyPrevent developmental and speech delay
      HemoglobinopathiesSickle cell anemiaNewborns can present with severe anemia, vaso-occlusive crisis, chronic abdominal pain, hyposplenism and infections.Early initiation of primary prevention of acute complications, as well as hematopoietic stem cell transplantationPrevent recurrent acute vaso-occlusive episodes and with successful hematopoietic stem cell transplantation achieve a normal asymptomatic life
      HemoglobinopathiesSickle cell anemiaNewborns can present with severe anemia, vaso-occlusive crisis, chronic abdominal pain, hyposplenism and infections.Early initiation of primary prevention of acute complications, as well as hematopoietic stem cell transplantationPrevent recurrent acute vaso-occlusive episodes and with successful hematopoietic stem cell transplantation achieve a normal asymptomatic life
      NeuromuscularSpinal Muscular AtrophyCharacterized by diffuse symmetric proximal muscle weakness greater in lower than upper extremities with absent or markedly decreased deep tendon reflexes.Early initiation of disease-modifying therapy and supportive therapyImprove quality of life and increase survival of affected individuals
      NeuromuscularSpinal Muscular AtrophyCharacterized by diffuse symmetric proximal muscle weakness greater in lower than upper extremities with absent or markedly decreased deep tendon reflexes.Early initiation of disease-modifying therapy and supportive therapyImprove quality of life and increase survival of affected individuals
      Documentation

      Clinical Sheet

      Download

      Brochure

      Download

      Gene List

      Download

      Report Guidelines

      Download
      Scientific Evidence

      Relevant related studies:

      ACOG Committee Opinion No. 778 Summary: Newborn Screening and the Role of the Obstetrician–Gynecologist. (2019). Obstetrics & Gynecology, 133(5), 1073-1074. doi: 10.1097/aog.0000000000003246

      https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp/index.html#:~:text=The%20RUSP%20is%20a%20list,newborn%20screening%20(NBS)%20programs

      van Campen, Sollars, Thomas, Bartlett, Milano, & Parker et al. (2019). Next Generation Sequencing in Newborn Screening in the United Kingdom National Health Service. International Journal Of Neonatal Screening, 5(4), 40. doi: 10.3390/ijns5040040

      Adhikari, A. N., Gallagher, R. C., Wang, Y., Currier, R. J., Amatuni, G., Bassaganyas, L., Chen, F., Kundu, K., Kvale, M., Mooney, S. D., Nussbaum, R. L., Randi, S. S., Sanford, J., Shieh, J. T., Srinivasan, R., Sunderam, U., Tang, H., Vaka, D., Zou, Y., Koenig, B. A., … Brenner, S. E. (2020). The role of exome sequencing in newborn screening for inborn errors of metabolism. Nature medicine, 26(9), 1392–1397. https://doi.org/10.1038/s41591-020-0966-5

      Rajabi, F. (2018). Updates in Newborn Screening. Pediatric Annals, 47(5). doi: 10.3928/19382359-20180426-01

      Wang, W., Yang, J., Xue, J., Mu, W., Zhang, X., Wu, W., Xu, M., Gong, Y., Liu, Y., Zhang, Y., Xie, X., Gu, W., Bai, J., & Cram, D. S. (2019). A comprehensive multiplex PCR based exome-sequencing assay for rapid bloodspot confirmation of inborn errors of metabolism. BMC medical genetics, 20(1), 3. https://doi.org/10.1186/s12881-018-0731-5

      Waisbren, S., Bäck, D., Liu, C., Kalia, S., Ringer, S., Holm, I., & Green, R. (2014). Parents are interested in newborn genomic testing during the early postpartum period. Genetics In Medicine, 17(6), 501-504. doi: 10.1038/gim.2014.139 

      Pereira, S., Robinson, J. O., Gutierrez, A. M., Petersen, D. K., Hsu, R. L., Lee, C. H., Schwartz, T. S., Holm, I. A., Beggs, A. H., Green, R. C., McGuire, A. L., & BabySeq Project Group (2019). Perceived Benefits, Risks, and Utility of Newborn Genomic Sequencing in the BabySeq Project. Pediatrics, 143(Suppl 1), S6–S13. https://doi.org/10.1542/peds.2018-1099C

       

      FAQs

      Opening hours, contact details, lab address...

      User manual

      Igenomix and fertility

      We work to make a world in which infertility is no longer an impossible barrier. Together with clinics and fertility specialists worldwide, we investigate human reproduction to change the lives of those who are trying to conceive.

      Learn more about Igenomix

      Other services

      WES

      Analyze the entire coding sequence of a gene

      More information
      CGT Carrier Genetic Test

      CGT

      Determines the risk of having a child with a genetic disease

      More information

      CMA

      Deletions or duplications at the chromosomal level

      More information

      Other services

      WES

      Analyze the entire coding sequence of a gene

      More information
      CGT Carrier Genetic Test

      CGT

      Determines the risk of having a child with a genetic disease

      More information

      CMA

      Deletions or duplications at the chromosomal level

      More information

      Igenomix is in the media

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