Help patients get answers and support for complex questions with a trusted partner in genetic testing and counseling. Access to Expert Genetic Counseling Integrated Genetics has the largest national genetic counseling network. We offer both in-person and easy access telegenetic genetic counseling that allows patients to interact directly and “face-to-face” with our genetic counselors. Our counselors take complex genetic data and turn it into practical, understandable, information and options, which can help in making important, highly personal healthcare choices. From a Company You Know and Trust informaSeq, an advanced and accurate prenatal test prenatal testing directed by board-certified molecular geneticists as early as 10 weeks’ gestational age Accurate Testing performed via deep sequencing, which increases detection, even in samples with a lower fraction of fetal DNA fragments Dual Threshold resulting stratifies risk prediction Quick resulting – 5-7 business days Genetic counseling, to give your patients vital information Genetic Risk Assessment Patient Education Patient Information Coordinated Patient Care We evaluate reproductive and family history, review test results and medical records, and identify genetic risk factors that can affect the patient or offspring. More We address any identified genetic risk factors, discuss the disorder in question, including etiology, heritability, and clinical implications, and explain testing and procedure options. Integrated Genetics, an experienced partner than 140 Integrated Genetics Genetic Counselors to help patients review results, identify risk factors, and make more informed decisions Convenient Over A We support the decision-making process by providing patients clinical information and referrals to community resources. Telegenetic Counseling services providing access for more patients 25 years of genetic testing expertise complete menu of screening and diagnostic tests focused on women’s reproductive health Contracts Over with more than 400 payors nationwide 1,700 patient service centers for convenient access to sample collection We provide a summary report to the referring physician and follow-up genetic counseling if indicated. Specimen Requirements To learn more about genetic counseling services, please speak to your Integrated Genetics sales representative or call 855-GC-CALLS (855-422-2557) to obtain additional information. Whole Blood Use only the black and tan capped blood collection tubes from the informaSeq kit One Streck tube, minimum 7 mL Store samples at room temperature and transport at ambient temperature in the informaSeq kit Affordable Payment Options for Your Patients Insurance Integrated Genetics is contracted with over 400 healthcare plans, helping patients maximize their benefits Patient specific programs Payment plans, special payment plans for financial hardship, and indigent requests from a physician or clinical facility Medicare/Medicaid Integrated Genetics accepts both Medicare and Medicaid and will bill these programs on the patient’s behalf Integrated Genetics – a leading provider of reproductive genetic testing services, driven by its commitment to physicians and patients. Learn more by visiting www.integratedgenetics.com or calling Integrated Genetics Client Services at 800-848-4436. Turnaround Time: 5 -7 business days A test your patients can trust. A company you know and trust. informaSeq SM Prenatal Test is Powered by Illumina® sequencing technology. informaSeqSM Prenatal Test – an advanced, non-invasive, next generation prenatal screening for T21, T18, and T13 chromosomal aneuploidies. When you recommend informaSeq, you’re choosing a trusted partner. Please call us toll-free at 800-845-6167 for any billing questions. We are available between the hours of 8:00 AM and 5:00 PM, Monday through Friday. informaSeq , SequentialScreen SM, IntegratedScreen SM, and Serum IntegratedScreen SM are service marks of Laboratory Corporation of America ® Holdings. FirstScreen ® and Afp4® are registered service marks of Laboratory Corporation of America ® Holdings. Powered by Illumina ® is a trademark of Illumina, Inc. in the U.S. and/or other countries ©2014 Laboratory Corporation of America ® Holdings. All rights reserved. rep-880-v2-0914 L13272-0914-2 SM www.mytestingoptions.com www.integratedgenetics.com From a Company You Know You Can Trust informaSeqSM Prenatal Test Answers Your Patients Can Trust P Reliable results support informed decision making. rovide your patients with a precise, non-invasive test that can assess risk for multiple fetal chromosomal aneuploidies from a single blood draw. Simple and safe, informaSeq can be administered as early as 10 weeks, giving you and your patients the information you both need. When you recommend prenatal testing for your patients, you can do so with confidence in our company, our laboratory, and the test. informaSeq’s high detection rates (sensitivity) and low false positive rates (specificity) for common chromosomal and sex aneuploidies provide reliable answers you and your patients can trust. Predictive Values2,3 Intended Use informaSeq is intended for patients with singleton, twin, and donor pregnancies as early as 10 weeks gestation who meet any of the following criteria: Advanced maternal age (≥35 years for singleton and twin pregnancies) Positive serum screen Abnormal ultrasound Increased risk of T21, T18, T13 (or sex chromosome aneuploidy in singleton pregnancy) ] ACOG and Society of Maternal Fetal Medicine (SMFM) Committee recognized the tremendous potential of cell-free DNA (cfDNA) testing and concluded that cfDNA testing can be offered to informed patients at increased risk of aneuploidy.1 Positive Predictive Value Negative Predictive Value 21 99.4% 99.9% 18 91.0% 99.9% 13 84.3% 99.9% Sensitivity The basic informaSeq test screens for: Optional testing detects: Monosomy (Down syndrome) X XX (Triple X) T18 (Edwards syndrome) X XY (Klinefelter syndrome) T13 (Patau syndrome) X YY (Jacobs syndrome) sex (XX or XY) – aids in stratifying the risk for X-linked disorders such as hemophilia ANEUPLOIDY SUSPECTED NOT DETECTED Yes Sensitivity Specificity 99.8% MX 95.0% 99.0% 99.6% XX 97.6% 99.2% >99.9% XY 99.1% 98.9% XXX XXY XYY These are more rare aneuploidies with limited data, precluding performance calculations. 97.4% 13 87.5% Sex chromosome mosaicism cannot be distinguished by this method (the occurrence of which is <0.3%). Fetal REFERENCES 1.Noninvasive prenatal testing for fetal aneuploidy. Committee Opinion No. 545. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012; 120:1532-4. 2.Futch, T, Spinosa J, Bhatt, S, de Feo E, Rava RP, Sehnert AJ. Initial clinical laboratory experience in noninvasive prenatal testing for fetal aneuploidy from maternal plasma DNA samples. Prenat Diagn 2013:33-569-574. 3.Based on internal correlation data. 4.Verinata Health, Inc. (2012) analytical validation of the verifi® Prenatal Test: Enhanced Test Performance For Detecting Trisomies 21, 18, 13 and the Option for Classification of Sex Chromosome Status. Redwood City, CA. 5.ACOG Practice Bulletin 77. Screening for fetal chromosomal abnormalities. Obstet Gynecol 2007; 109:217-227. www.mytestingoptions.com Counsel the patient about informaSeq prenatal test and diagnostic test options. Counsel the patient about the informaSeq prenatal test, its risks and limitations, and diagnostic test options. No Does the patient elect testing? Counsel the patient about testing options per ACOG Practice Bulletin, Screening for Fetal Chromosomal Abnormalities.5 Yes Serum Screening (per practice’s protocol) CVS/Amniocentesis (Diagnostic) Genetic Counseling is an appropriate option Test performance in the most common sex chromosomes4 Specificity No >99.9% 18 X (MX; Turner syndrome) T21 DETECTED Is the patient at increased risk for aneuploidy? With any screening test, false positives and false negatives can occur. However, the informaSeq test provides context by reporting a “highest risk” result as “aneuploidy detected” and a lower risk, more borderline result as “aneuploidy suspected”. You and your patients may use these distinctions to help determine the best next steps. 21 Testing for Trisomies 21, 18, and 13 Test Results Test performance in the most common chromosomal aneuploidies4 Please note: This test does not assess risk for mosaicism, partial trisomies, or translocations. When choosing a laboratory to perform important tests, it is also critical that the laboratory have the capability to provide the necessary follow-up testing and/or counseling your patients may require. Integrated Genetics is your lab for a full complement of reproductive genetic screening and diagnostic options. Yes Is the serum screen result increased risk? Is the informaSeq test result Aneuploidy Detected or Suspected? No No Yes Yes Does the patient elect testing? No Continue with pregnancy management according to your practice’s protocols. Serum Screening Support for Your Practice Protocol Trust Integrated Genetics to offer you the Right Test at the Right Time for your serum screening needs. If serum screening is desired, you can choose from the following: First trimester – FirstScreen® First and second trimester combined – SequentialScreenSM, IntegratedScreenSM, and Serum IntegratedScreenSM Second trimester – Afp4® www.integratedgenetics.com From a Company You Know You Can Trust informaSeqSM Prenatal Test Answers Your Patients Can Trust P Reliable results support informed decision making. rovide your patients with a precise, non-invasive test that can assess risk for multiple fetal chromosomal aneuploidies from a single blood draw. Simple and safe, informaSeq can be administered as early as 10 weeks, giving you and your patients the information you both need. When you recommend prenatal testing for your patients, you can do so with confidence in our company, our laboratory, and the test. informaSeq’s high detection rates (sensitivity) and low false positive rates (specificity) for common chromosomal and sex aneuploidies provide reliable answers you and your patients can trust. Predictive Values2,3 Intended Use informaSeq is intended for patients with singleton, twin, and donor pregnancies as early as 10 weeks gestation who meet any of the following criteria: Advanced maternal age (≥35 years for singleton and twin pregnancies) Positive serum screen Abnormal ultrasound Increased risk of T21, T18, T13 (or sex chromosome aneuploidy in singleton pregnancy) ] ACOG and Society of Maternal Fetal Medicine (SMFM) Committee recognized the tremendous potential of cell-free DNA (cfDNA) testing and concluded that cfDNA testing can be offered to informed patients at increased risk of aneuploidy.1 Positive Predictive Value Negative Predictive Value 21 99.4% 99.9% 18 91.0% 99.9% 13 84.3% 99.9% Sensitivity The basic informaSeq test screens for: Optional testing detects: Monosomy (Down syndrome) X XX (Triple X) T18 (Edwards syndrome) X XY (Klinefelter syndrome) T13 (Patau syndrome) X YY (Jacobs syndrome) sex (XX or XY) – aids in stratifying the risk for X-linked disorders such as hemophilia ANEUPLOIDY SUSPECTED NOT DETECTED Yes Sensitivity Specificity 99.8% MX 95.0% 99.0% 99.6% XX 97.6% 99.2% >99.9% XY 99.1% 98.9% XXX XXY XYY These are more rare aneuploidies with limited data, precluding performance calculations. 97.4% 13 87.5% Sex chromosome mosaicism cannot be distinguished by this method (the occurrence of which is <0.3%). Fetal REFERENCES 1.Noninvasive prenatal testing for fetal aneuploidy. Committee Opinion No. 545. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012; 120:1532-4. 2.Futch, T, Spinosa J, Bhatt, S, de Feo E, Rava RP, Sehnert AJ. Initial clinical laboratory experience in noninvasive prenatal testing for fetal aneuploidy from maternal plasma DNA samples. Prenat Diagn 2013:33-569-574. 3.Based on internal correlation data. 4.Verinata Health, Inc. (2012) analytical validation of the verifi® Prenatal Test: Enhanced Test Performance For Detecting Trisomies 21, 18, 13 and the Option for Classification of Sex Chromosome Status. Redwood City, CA. 5.ACOG Practice Bulletin 77. Screening for fetal chromosomal abnormalities. Obstet Gynecol 2007; 109:217-227. www.mytestingoptions.com Counsel the patient about informaSeq prenatal test and diagnostic test options. Counsel the patient about the informaSeq prenatal test, its risks and limitations, and diagnostic test options. No Does the patient elect testing? Counsel the patient about testing options per ACOG Practice Bulletin, Screening for Fetal Chromosomal Abnormalities.5 Yes Serum Screening (per practice’s protocol) CVS/Amniocentesis (Diagnostic) Genetic Counseling is an appropriate option Test performance in the most common sex chromosomes4 Specificity No >99.9% 18 X (MX; Turner syndrome) T21 DETECTED Is the patient at increased risk for aneuploidy? With any screening test, false positives and false negatives can occur. However, the informaSeq test provides context by reporting a “highest risk” result as “aneuploidy detected” and a lower risk, more borderline result as “aneuploidy suspected”. You and your patients may use these distinctions to help determine the best next steps. 21 Testing for Trisomies 21, 18, and 13 Test Results Test performance in the most common chromosomal aneuploidies4 Please note: This test does not assess risk for mosaicism, partial trisomies, or translocations. When choosing a laboratory to perform important tests, it is also critical that the laboratory have the capability to provide the necessary follow-up testing and/or counseling your patients may require. Integrated Genetics is your lab for a full complement of reproductive genetic screening and diagnostic options. Yes Is the serum screen result increased risk? Is the informaSeq test result Aneuploidy Detected or Suspected? No No Yes Yes Does the patient elect testing? No Continue with pregnancy management according to your practice’s protocols. Serum Screening Support for Your Practice Protocol Trust Integrated Genetics to offer you the Right Test at the Right Time for your serum screening needs. If serum screening is desired, you can choose from the following: First trimester – FirstScreen® First and second trimester combined – SequentialScreenSM, IntegratedScreenSM, and Serum IntegratedScreenSM Second trimester – Afp4® www.integratedgenetics.com From a Company You Know You Can Trust informaSeqSM Prenatal Test Answers Your Patients Can Trust P Reliable results support informed decision making. rovide your patients with a precise, non-invasive test that can assess risk for multiple fetal chromosomal aneuploidies from a single blood draw. Simple and safe, informaSeq can be administered as early as 10 weeks, giving you and your patients the information you both need. When you recommend prenatal testing for your patients, you can do so with confidence in our company, our laboratory, and the test. informaSeq’s high detection rates (sensitivity) and low false positive rates (specificity) for common chromosomal and sex aneuploidies provide reliable answers you and your patients can trust. Predictive Values2,3 Intended Use informaSeq is intended for patients with singleton, twin, and donor pregnancies as early as 10 weeks gestation who meet any of the following criteria: Advanced maternal age (≥35 years for singleton and twin pregnancies) Positive serum screen Abnormal ultrasound Increased risk of T21, T18, T13 (or sex chromosome aneuploidy in singleton pregnancy) ] ACOG and Society of Maternal Fetal Medicine (SMFM) Committee recognized the tremendous potential of cell-free DNA (cfDNA) testing and concluded that cfDNA testing can be offered to informed patients at increased risk of aneuploidy.1 Positive Predictive Value Negative Predictive Value 21 99.4% 99.9% 18 91.0% 99.9% 13 84.3% 99.9% Sensitivity The basic informaSeq test screens for: Optional testing detects: Monosomy (Down syndrome) X XX (Triple X) T18 (Edwards syndrome) X XY (Klinefelter syndrome) T13 (Patau syndrome) X YY (Jacobs syndrome) sex (XX or XY) – aids in stratifying the risk for X-linked disorders such as hemophilia ANEUPLOIDY SUSPECTED NOT DETECTED Yes Sensitivity Specificity 99.8% MX 95.0% 99.0% 99.6% XX 97.6% 99.2% >99.9% XY 99.1% 98.9% XXX XXY XYY These are more rare aneuploidies with limited data, precluding performance calculations. 97.4% 13 87.5% Sex chromosome mosaicism cannot be distinguished by this method (the occurrence of which is <0.3%). Fetal REFERENCES 1.Noninvasive prenatal testing for fetal aneuploidy. Committee Opinion No. 545. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012; 120:1532-4. 2.Futch, T, Spinosa J, Bhatt, S, de Feo E, Rava RP, Sehnert AJ. Initial clinical laboratory experience in noninvasive prenatal testing for fetal aneuploidy from maternal plasma DNA samples. Prenat Diagn 2013:33-569-574. 3.Based on internal correlation data. 4.Verinata Health, Inc. (2012) analytical validation of the verifi® Prenatal Test: Enhanced Test Performance For Detecting Trisomies 21, 18, 13 and the Option for Classification of Sex Chromosome Status. Redwood City, CA. 5.ACOG Practice Bulletin 77. Screening for fetal chromosomal abnormalities. Obstet Gynecol 2007; 109:217-227. www.mytestingoptions.com Counsel the patient about informaSeq prenatal test and diagnostic test options. Counsel the patient about the informaSeq prenatal test, its risks and limitations, and diagnostic test options. No Does the patient elect testing? Counsel the patient about testing options per ACOG Practice Bulletin, Screening for Fetal Chromosomal Abnormalities.5 Yes Serum Screening (per practice’s protocol) CVS/Amniocentesis (Diagnostic) Genetic Counseling is an appropriate option Test performance in the most common sex chromosomes4 Specificity No >99.9% 18 X (MX; Turner syndrome) T21 DETECTED Is the patient at increased risk for aneuploidy? With any screening test, false positives and false negatives can occur. However, the informaSeq test provides context by reporting a “highest risk” result as “aneuploidy detected” and a lower risk, more borderline result as “aneuploidy suspected”. You and your patients may use these distinctions to help determine the best next steps. 21 Testing for Trisomies 21, 18, and 13 Test Results Test performance in the most common chromosomal aneuploidies4 Please note: This test does not assess risk for mosaicism, partial trisomies, or translocations. When choosing a laboratory to perform important tests, it is also critical that the laboratory have the capability to provide the necessary follow-up testing and/or counseling your patients may require. Integrated Genetics is your lab for a full complement of reproductive genetic screening and diagnostic options. Yes Is the serum screen result increased risk? Is the informaSeq test result Aneuploidy Detected or Suspected? No No Yes Yes Does the patient elect testing? No Continue with pregnancy management according to your practice’s protocols. Serum Screening Support for Your Practice Protocol Trust Integrated Genetics to offer you the Right Test at the Right Time for your serum screening needs. If serum screening is desired, you can choose from the following: First trimester – FirstScreen® First and second trimester combined – SequentialScreenSM, IntegratedScreenSM, and Serum IntegratedScreenSM Second trimester – Afp4® www.integratedgenetics.com Help patients get answers and support for complex questions with a trusted partner in genetic testing and counseling. Access to Expert Genetic Counseling Integrated Genetics has the largest national genetic counseling network. We offer both in-person and easy access telegenetic genetic counseling that allows patients to interact directly and “face-to-face” with our genetic counselors. Our counselors take complex genetic data and turn it into practical, understandable, information and options, which can help in making important, highly personal healthcare choices. From a Company You Know and Trust informaSeq, an advanced and accurate prenatal test prenatal testing directed by board-certified molecular geneticists as early as 10 weeks’ gestational age Accurate Testing performed via deep sequencing, which increases detection, even in samples with a lower fraction of fetal DNA fragments Dual Threshold resulting stratifies risk prediction Quick resulting – 5-7 business days Genetic counseling, to give your patients vital information Genetic Risk Assessment Patient Education Patient Information Coordinated Patient Care We evaluate reproductive and family history, review test results and medical records, and identify genetic risk factors that can affect the patient or offspring. More We address any identified genetic risk factors, discuss the disorder in question, including etiology, heritability, and clinical implications, and explain testing and procedure options. Integrated Genetics, an experienced partner than 140 Integrated Genetics Genetic Counselors to help patients review results, identify risk factors, and make more informed decisions Convenient Over A We support the decision-making process by providing patients clinical information and referrals to community resources. Telegenetic Counseling services providing access for more patients 25 years of genetic testing expertise complete menu of screening and diagnostic tests focused on women’s reproductive health Contracts Over with more than 400 payors nationwide 1,700 patient service centers for convenient access to sample collection We provide a summary report to the referring physician and follow-up genetic counseling if indicated. Specimen Requirements To learn more about genetic counseling services, please speak to your Integrated Genetics sales representative or call 855-GC-CALLS (855-422-2557) to obtain additional information. Whole Blood Use only the black and tan capped blood collection tubes from the informaSeq kit One Streck tube, minimum 7 mL Store samples at room temperature and transport at ambient temperature in the informaSeq kit Affordable Payment Options for Your Patients Insurance Integrated Genetics is contracted with over 400 healthcare plans, helping patients maximize their benefits Patient specific programs Payment plans, special payment plans for financial hardship, and indigent requests from a physician or clinical facility Medicare/Medicaid Integrated Genetics accepts both Medicare and Medicaid and will bill these programs on the patient’s behalf Integrated Genetics – a leading provider of reproductive genetic testing services, driven by its commitment to physicians and patients. Learn more by visiting www.integratedgenetics.com or calling Integrated Genetics Client Services at 800-848-4436. Turnaround Time: 5 -7 business days A test your patients can trust. A company you know and trust. informaSeq SM Prenatal Test is Powered by Illumina® sequencing technology. informaSeqSM Prenatal Test – an advanced, non-invasive, next generation prenatal screening for T21, T18, and T13 chromosomal aneuploidies. When you recommend informaSeq, you’re choosing a trusted partner. Please call us toll-free at 800-845-6167 for any billing questions. We are available between the hours of 8:00 AM and 5:00 PM, Monday through Friday. informaSeq , SequentialScreen SM, IntegratedScreen SM, and Serum IntegratedScreen SM are service marks of Laboratory Corporation of America ® Holdings. FirstScreen ® and Afp4® are registered service marks of Laboratory Corporation of America ® Holdings. Powered by Illumina ® is a trademark of Illumina, Inc. in the U.S. and/or other countries ©2014 Laboratory Corporation of America ® Holdings. All rights reserved. rep-880-v2-0914 L13272-0914-2 SM www.mytestingoptions.com www.integratedgenetics.com Help patients get answers and support for complex questions with a trusted partner in genetic testing and counseling. Access to Expert Genetic Counseling Integrated Genetics has the largest national genetic counseling network. We offer both in-person and easy access telegenetic genetic counseling that allows patients to interact directly and “face-to-face” with our genetic counselors. Our counselors take complex genetic data and turn it into practical, understandable, information and options, which can help in making important, highly personal healthcare choices. From a Company You Know and Trust informaSeq, an advanced and accurate prenatal test prenatal testing directed by board-certified molecular geneticists as early as 10 weeks’ gestational age Accurate Testing performed via deep sequencing, which increases detection, even in samples with a lower fraction of fetal DNA fragments Dual Threshold resulting stratifies risk prediction Quick resulting – 5-7 business days Genetic counseling, to give your patients vital information Genetic Risk Assessment Patient Education Patient Information Coordinated Patient Care We evaluate reproductive and family history, review test results and medical records, and identify genetic risk factors that can affect the patient or offspring. More We address any identified genetic risk factors, discuss the disorder in question, including etiology, heritability, and clinical implications, and explain testing and procedure options. Integrated Genetics, an experienced partner than 140 Integrated Genetics Genetic Counselors to help patients review results, identify risk factors, and make more informed decisions Convenient Over A We support the decision-making process by providing patients clinical information and referrals to community resources. Telegenetic Counseling services providing access for more patients 25 years of genetic testing expertise complete menu of screening and diagnostic tests focused on women’s reproductive health Contracts Over with more than 400 payors nationwide 1,700 patient service centers for convenient access to sample collection We provide a summary report to the referring physician and follow-up genetic counseling if indicated. Specimen Requirements To learn more about genetic counseling services, please speak to your Integrated Genetics sales representative or call 855-GC-CALLS (855-422-2557) to obtain additional information. Whole Blood Use only the black and tan capped blood collection tubes from the informaSeq kit One Streck tube, minimum 7 mL Store samples at room temperature and transport at ambient temperature in the informaSeq kit Affordable Payment Options for Your Patients Insurance Integrated Genetics is contracted with over 400 healthcare plans, helping patients maximize their benefits Patient specific programs Payment plans, special payment plans for financial hardship, and indigent requests from a physician or clinical facility Medicare/Medicaid Integrated Genetics accepts both Medicare and Medicaid and will bill these programs on the patient’s behalf Integrated Genetics – a leading provider of reproductive genetic testing services, driven by its commitment to physicians and patients. Learn more by visiting www.integratedgenetics.com or calling Integrated Genetics Client Services at 800-848-4436. Turnaround Time: 5 -7 business days A test your patients can trust. A company you know and trust. informaSeq SM Prenatal Test is Powered by Illumina® sequencing technology. informaSeqSM Prenatal Test – an advanced, non-invasive, next generation prenatal screening for T21, T18, and T13 chromosomal aneuploidies. When you recommend informaSeq, you’re choosing a trusted partner. Please call us toll-free at 800-845-6167 for any billing questions. We are available between the hours of 8:00 AM and 5:00 PM, Monday through Friday. informaSeq , SequentialScreen SM, IntegratedScreen SM, and Serum IntegratedScreen SM are service marks of Laboratory Corporation of America ® Holdings. FirstScreen ® and Afp4® are registered service marks of Laboratory Corporation of America ® Holdings. Powered by Illumina ® is a trademark of Illumina, Inc. in the U.S. and/or other countries ©2014 Laboratory Corporation of America ® Holdings. All rights reserved. rep-880-v2-0914 L13272-0914-2 SM www.mytestingoptions.com www.integratedgenetics.com
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