niman

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  1. http://www.renseradio.com/listenlive.htm
  2. Tonight at 10 PM - Personal DNA Testing THURSDAY Dr. Henry L. Niman, PhD
  3. FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions SHARE TWEET LINKEDIN PIN IT EMAIL PRINT For Immediate Release April 6, 2017 Release Español The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional. “Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.” The GHR tests are intended to provide genetic risk information to consumers, but the tests cannot determine a person’s overall risk of developing a disease or condition. In addition to the presence of certain genetic variants, there are many factors that contribute to the development of a health condition, including environmental and lifestyle factors. The 23andMe GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants. The presence or absence of some of these variants is associated with an increased risk for developing any one of the following 10 diseases or conditions: Parkinson’s disease, a nervous system disorder impacting movement; Late-onset Alzheimer’s disease, a progressive brain disorder that destroys memory and thinking skills; Celiac disease, a disorder resulting in the inability to digest gluten; Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease; Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements; Factor XI deficiency, a blood clotting disorder; Gaucher disease type 1, an organ and tissue disorder; Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition; Hereditary hemochromatosis, an iron overload disorder; and Hereditary thrombophilia, a blood clot disorder. The FDA reviewed data for the 23andMe GHR tests through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. Along with this authorization, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the tests’ accuracy, reliability and clinical relevance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for these and similar GHR tests. In addition, the FDA intends to exempt additional 23andMe GHR tests from the FDA’s premarket review, and GHR tests from other makers may be exempt after submitting their first premarket notification. A proposed exemption of this kind would allow other, similar tests to enter the market as quickly as possible and in the least burdensome way, after a one-time FDA review. “The special controls describe the testing that 23andMe conducted to demonstrate the performance of these tests and clarify agency expectations for developers of other GHRs,” said Dr. Shuren. “By establishing special controls and eventually, a premarket review exemption, the FDA can provide a streamlined, flexible approach for tests using similar technologies to enter the market while the agency continues to help ensure that they provide accurate and reproducible results.” Excluded from today’s marketing authorization and any future, related exemption are GHR tests that function as diagnostic tests. Diagnostic tests are often used as the sole basis for major treatment decisions, such as a genetic test for BRCA, for which a positive result may lead to prophylactic (preventative) surgical removal of breasts or ovaries. Authorization of the 23andMe GHR tests was supported by data from peer-reviewed, scientific literature that demonstrated a link between specific genetic variants and each of the 10 health conditions. The published data originated from studies that compared genetic variants present in people with a specific condition to those without that condition. The FDA also reviewed studies, which demonstrated that 23andMe GHR tests correctly and consistently identified variants associated with the 10 indicated conditions or diseases from a saliva sample. The FDA requires the results of all DTC tests used for medical purposes be communicated in a way that consumers can understand and use. A user study showed that the 23andMe GHR tests’ instructions and reports were easy to follow and understand. The study indicated that people using the tests understood more than 90 percent of the information presented in the reports. Risks associated with use of the 23andMe GHR tests include false positive findings, which can occur when a person receives a result indicating incorrectly that he or she has a certain genetic variant, and false negative findings that can occur when a user receives a result indicating incorrectly that he or she does not have a certain genetic variant. Results obtained from the tests should not be used for diagnosis or to inform treatment decisions. Users should consult a health care professional with questions or concerns about results. The FDA granted market authorization of the Personal Genome Service GHR tests to 23andMe, Inc. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm
  4. I have recently begun to look at personal DNA testing. Initial observations are for two of the more popular home tests (23andme and ancestry.com). Both services include raw data on over 500,000 snps, which include many predictive markers for a variety of medical conditions, including cancer. Recently, 10 of the 23andme tests have received FDA approval.
  5. Idaho Payette County in the State of Idaho, on or after December 19, 2014 and before May 19, 2015 as well as on or after April 11, 2017 are ineligible for export.* https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-requirements-by-country/Nicaragua
  6. Idaho Payette County in the State of Idaho, on or after December 19, 2014 and before May 19, 2015 as well as on or after April 13, 2017 are ineligible for export.* https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-requirements-by-country/Honduras
  7. Idaho - Poultry meat and meat products loaded on board vessel on or before April 10, 2017.* https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-requirements-by-country/taiwan
  8. Poultry slaughtered on or after March 15, 2017, which originated from or passed through or is slaughtered/processed within the zone shown on the attached map is ineligible. Within the zone, poultry slaughtered and processed before March 15 , 2017 is eligible.* https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-requirements-by-country/Japan
  9. References Meaney-Delman D, Hills SL, Williams C, et al. Zika virus infection among U.S. pregnant travelers, August 2015–February 2016. MMWR Morb Mortal Wkly Rep 2016;65:211–4. CrossRef PubMed Simeone RM, Shapiro-Mendoza CK, Meaney-Delman D, et al. ; Zika and Pregnancy Working Group. Possible Zika virus infection among pregnant women—United States and Territories, May 2016. MMWR Morb Mortal Wkly Rep 2016;65:514–9. CrossRef PubMed Honein MA, Dawson AL, Petersen EE, et al. ; US Zika Pregnancy Registry Collaboration. Birth defects among fetuses and infants of US women with evidence of possible Zika virus infection during pregnancy. JAMA 2017;317:59–68. CrossRef PubMed Cragan JD, Mai CT, Petersen EE, et al. Baseline prevalence of birth defects associated with congenital Zika virus infection—Massachusetts, North Carolina, and Atlanta, Georgia, 2013–2014. MMWR Morb Mortal Wkly Rep 2017;66:219–22. CrossRef PubMed Rabe IB, Staples JE, Villanueva J, et al. ; MTS. Interim guidance for interpretation of Zika virus antibody test results. MMWR Morb Mortal Wkly Rep 2016;65:543–6. CrossRef PubMed Council of State and Territorial Epidemiologists. Zika virus disease and Zika virus infection 2016 case definition. CSTE position statement 16-IC-01. Atlanta, GA: Council of State and Territorial Epidemiologists; 2016. https://wwwn.cdc.gov/nndss/conditions/zika/case-definition/2016/06/ Moore CA, Staples JE, Dobyns WB, et al. Characterizing the pattern of anomalies in congenital Zika syndrome for pediatric clinicians. JAMA Pediatr 2017;171:288–95. CrossRef PubMed Russell K, Oliver SE, Lewis L, et al. ; Contributors. Update: interim guidance for the evaluation and management of infants with possible congenital Zika virus infection—United States, August 2016. MMWR Morb Mortal Wkly Rep 2016;65:870–8. CrossRef PubMed van der Linden V, Pessoa A, Dobyns W, et al. Description of 13 infants born during October 2015–January 2016 with congenital Zika virus infection without microcephaly at Birth—Brazil. MMWR Morb Mortal Wkly Rep 2016;65:1343–8. CrossRef PubMed Alarcon A, Martinez-Biarge M, Cabañas F, Quero J, García-Alix A. A prognostic neonatal neuroimaging scale for symptomatic congenital cytomegalovirus infection. Neonatology 2016;110:277–85. CrossRef PubMed Bhatnagar J, Rabeneck DB, Martines RB, et al. Zika virus RNA replication and persistence in brain and placental tissue. Emerg Infect Dis 2017;23:405–14. CrossRef PubMed Oduyebo T, Igbinosa I, Petersen EE, et al. Update: interim guidance for health care providers caring for pregnant women with possible Zika virus exposure—United States, July 2016. MMWR Morb Mortal Wkly Rep 2016;65:739–44. CrossRef PubMed
  10. TABLE 2. Postnatal neuroimaging* and infant Zika virus testing results for 895 liveborn infants in the U.S. Zika Pregnancy Registry — 50 U.S. states and the District of Columbia, 2016 Testing No (%) liveborn infants With birth defects Without birth defects Total Total 45 850 895 Neuroimaging Any neuroimaging reported to USZPR 29 (64) 192 (23) 221 (25) Infant Zika virus testing Positive test result on an infant specimen†,§ 25 (56) 69 (8) 94 (11) Negative infant test results among infants with ≥1 infant specimen reported as tested 17 (38) 474 (56) 491 (55) No infant specimen test results reported to USZPR 3 (7) 307 (36) 310 (35) Abbreviations: IgM= immunoglobulin M; NAT=nucleic acid test; RT-PCR = reverse transcription–polymerase chain reaction; USZPR = U.S. Zika Pregnancy Registry. * Neuroimaging includes any cranial ultrasound, computed tomography, or magnetic resonance imaging test reported to the USZPR. † Positive infant tests included the presence of Zika virus RNA by a positive NAT (e.g., RT-PCR) and/or serological results of IgM positive/equivocal. § Infant specimens include serum, urine, blood, cerebrospinal fluid, cord serum, and cord blood.
  11. TABLE 1. Pregnancy outcomes* for 972 women with completed pregnancies† with laboratory evidence of possible recent Zika virus infection, by maternal symptom status and timing of symptom onset or exposure — U.S. Zika Pregnancy Registry, United States, December 2015–December 2016 Characteristic Brain abnormalities and/or microcephaly (No.) NTDs and early brain malformations, eye abnormalities, or consequences of CNS dysfunction without brain abnormalities or microcephaly (No.) Total with ≥1 birth defect (No.) Completed pregnancies (No.) Proportion affected by Zika virus–associated birth defects, % (95% CI§) Any laboratory evidence of possible recent Zika virus infection¶ Total 43 8 51 972 5 (4–7) Maternal symptom status Symptoms of Zika virus infection reported 18 3 21 348 6 (4–9) No symptoms of Zika virus infection reported 24 4 28 599 5 (3–7) Unknown 1 1 2 25 — Timing of symptoms or exposure** First trimester††,§§ 13 1 14 157 9 (5–14) Multiple trimesters including first 22 6 28 396 7 (5–10) Confirmed evidence of Zika virus infection¶¶ Total 18 6 24 250 10 (7–14) Maternal symptom status Symptoms of Zika virus infection reported 8 3 11 141 8 (4–13) No symptoms of Zika virus infection reported 10 2 12 102 12 (7–19) Unknown 1 0 1 7 — Timing of symptoms or exposure** First trimester††,§§ 8 1 9 60 15 (8–26) Multiple trimesters including first 8 4 12 58 21 (12–33) Abbreviations: CI = confidence interval; CNS = central nervous system; IgM= immunoglobulin M; NAT=nucleic acid test; NTD = neural tube defect; PRNT = plaque reduction neutralization test; RT-PCR = reverse transcription–polymerase chain reaction. * Outcomes for multiple gestation pregnancies are counted once. † Includes live births, spontaneous abortions, terminations, and stillbirths. § 95% CI for a binomial proportion using Wilson score interval. ¶ Includes maternal, placental, or fetal/infant laboratory evidence of possible recent Zika virus infection based on presence of Zika virus RNA by a positive NAT (e.g., RT-PCR) or similar test, serological evidence of a recent Zika virus infection, or serological evidence of a recent unspecified flavivirus infection. ** Estimates were not calculated for exposure in other trimesters because of small numbers. Pregnant women who did not have first trimester exposure might have had exposure in the periconceptional period only (8 weeks before conception or 6 weeks before and 2 weeks after the first day of the last menstrual period), second trimester, third trimester, both the second and third trimester; many women were missing information on trimester of exposure. †† First trimester is defined as last menstrual period +14 days to 13 weeks, 6 days (97 days). §§ First trimester exposure includes women with exposure limited to the first trimester and women with exposure limited to the first trimester and periconceptional period. ¶¶ Includes maternal, placental, or fetal/infant laboratory evidence of confirmed Zika virus infection based on presence of Zika virus RNA by a positive NAT (e.g., RT-PCR) or similar test or serological results of IgM positive/equivocal with Zika PRNT ≥10 and dengue PRNT <10.
  12. Acknowledgments Alabama Zika Response Team, Alabama Department of Public Health; Alaska Division of Public Health; Division of Epidemiology-Disease Surveillance & Investigation, District of Columbia Department of Health; Illinois Department of Public Health Zika Response Team; The Iowa Department of Public Health; Kansas Department of Health and Environment; Kentucky Department for Public Health Zika Pregnancy Workgroup; Michigan Zika Pregnancy Registry Workgroup, Michigan Department of Health and Human Services; Missouri Department of Health and Senior Services; Office of Public Health Informatics and Epidemiology, Nevada Division of Public and Behavioral Health; Oregon Public Health Division Acute and Communicable Disease Program; Center for Acute Infectious Disease Epidemiology, Rhode Island Department of Health; Birth Defects Epidemiology and Surveillance Branch, Texas Department of State Health Services; Texas Department of State Health Services; Wisconsin Division of Public Health. U.S. Zika Pregnancy Registry Collaboration Jennifer Adair, MSW, Maricopa County Department of Public Health, Arizona; Irene Ruberto, PhD, Arizona Department of Health Services; Dirk T. Haselow, MD, PhD, Arkansas Department of Health; Lucille Im, MPH, Arkansas Department of Health; Wendy Jilek, MPH, California Department of Public Health; Monica S. Lehmann, MPH, MSN, California Department of Public Health, Center for Family Health, California Birth Defects Monitoring Program; Richard Olney, MD, California Department of Public Health; Charsey Cole Porse, PhD, California Department of Public Health; Karen C. Ramstrom, DO, California Department of Public Health; Similoluwa Sowunmi, MPH, California Department of Public Health; Natalie S. Marzec, MD, Colorado Department of Public Health and Environment; Karin Davis, Connecticut Department of Public Health; Brenda Esponda-Morrison, Connecticut Department of Public Health; M. Zachariah Fraser, Connecticut Department of Public Health; Colleen Ann O'Connor, MPH, Connecticut Department of Public Health; Wendy Chung, MD, Dallas County Health and Human Services; Folasuyi Richardson, MPH, Dallas County Health and Human Services; Taylor Sexton, MPH, Dallas County Health and Human Services; Meredith E. Stocks, MPH, Dallas County Health and Human Services; Senait Woldai, MPH, Dallas County Health and Human Services; Amanda M. Bundek, Delaware Division of Public Health; Jennifer Zambri, MBA, Delaware Division of Public Health, Office of Infectious Disease Epidemiology; Cynthia Goldberg, Miami, Dade County Health Department, Florida Department of Health; Leah Eisenstein, MPH, Florida Department of Health; Jennifer Jackson, MPH, Orange County Health Department, Florida Department of Health; Russell Kopit, MPH, Palm Beach County Health Department, Florida Department of Health; Teresa Logue, MPH, Miami/Dade County Health Department, Florida Department of Health; Raphael Mendoza, Broward County Health Department, Florida Department of Health; Amanda Feldpausch, MPH, Georgia Department of Public Health; Teri Graham, MPH, Georgia Department of Public Health; Sylvia Mann, MS, Hawaii Department of Health; Sarah Y. Park, MD, Hawaii Department of Health; Kris Kelly Carter, DVM, Idaho Division of Public Health, CDC, U.S. Public Health Service; Emily J. Potts, MPH, Indiana State Department of Health; Taryn Stevens, MPH, Indiana State Department of Health; Sean Simonson, MPH, Louisiana Department of Health; Julius L. Tonzel, MPH, Louisiana Department of Health; Shari Davis, MPH, Maine Center for Disease Control and Prevention; Sara Robinson, MPH, Maine Department of Health and Human Services; Judie K. Hyun, MHS, Maryland Department of Health and Mental Hygiene; Erin M. Jenkins, MPH, Maryland Department of Health and Mental Hygiene; Monika Piccardi, Maryland Department of Health and Mental Hygiene; Lawrence D. Reid, PhD, Maryland Department of Health and Mental Hygiene; Julie E. Dunn, PhD, Massachusetts Department of Public Health; Cathleen A. Higgins, Massachusetts Department of Public Health; Angela E. Lin, MD, Massachusetts General Hospital for Children; Gerlinde S. Munshi, MA, Massachusetts Department of Public Health; Kayleigh Sandhu, MPH, Massachusetts Department of Public Health; Sarah J. Scotland, MPH, Massachusetts Department of Public Health; Susan Soliva, MPH, Massachusetts Department of Public Health; Glenn Copeland, MBA, Michigan Department of Health and Human Services; Kimberly A. Signs, DVM, Michigan Department of Health and Human Services; Elizabeth Schiffman, MPH, MA, Minnesota Department of Health; Paul Byers, MD, Mississippi State Department of Health; Sheryl Hand, Mississippi State Department of Health; Christine L. Mulgrew, PhD, State of Montana; Jeff Hamik, MS, Division of Public Health, Nebraska Department of Health and Human Services; Samir Koirala, MSc, Division of Public Health, Nebraska Department of Health and Human Services; Lisa A. Ludwig, MD, Division of Public Health, Nebraska Department of Health and Human Services; Carolyn Rose Fredette, MPH, New Hampshire Department of Health and Human Services; Kristin Garafalo, MPH, New Jersey Department of Health; Karen Worthington, MS, New Jersey Department of Health; Abubakar Ropri, MPH, New Mexico State Department of Health; Julius Nchangtachi Ade, MD, DrPH, New York State Department of Health; Zahra S. Alaali, MPH, New York State Department of Health; Debra Blog, MD, New York State Department of Health; Scott J. Brunt, Wadsworth Center, New York State Department of Health; Patrick Bryant, PhD, Wadsworth Center, New York State Department of Health; Amy E. Burns, MS, New York State Department of Health; Steven Bush, MS, Wadsworth Center, New York State Department of Health; Kyle Carson, New York State Department of Health; Amy B. Dean, PhD, Wadsworth Center, New York State Department of Health; Valerie Demarest, Wadsworth Center, New York State Department of Health; Elizabeth M. Dufort, MD, New York State Department of Health; Alan P. Dupuis II, Wadsworth Center, New York State Department of Health; Ann Sullivan-Frohm, New York State Department of Health; Andrea Marias Furuya, PhD, Wadsworth Center, New York State Department of Health; Meghan Fuschino, MS, Wadsworth Center, New York State Department of Health; Viola H. Glaze, Health Research Inc; Jacquelin Griffin, New York State Department of Health; Christina Hidalgo, MPH, New York State Department of Health; Karen E. Kulas, Wadsworth Center, New York State Department of Health; Daryl M. Lamson, Wadsworth Center, New York State Department of Health; Lou Ann Lance, MSN, New York State Department of Health; William T. Lee, PhD, Wadsworth Center, New York State Department of Health; Ronald Limberger, PhD, Wadsworth Center, New York State Department of Health; Patricia S. Many, MS, New York State Department of Health; Mary J. Marchewka, Wadsworth Center, New York State Department of Health; Brenda Elizabeth Naizby, New York State Department of Health; MaryJo Polfleit, New York State Department of Health; Michael Popowich, Wadsworth Center, New York State Department of Health; Tabassum Rahman, MS, New York State Department of Health; Timothy Rem, New York State Department of Health; Amy E. Robbins, MPH, New York State Department of Health; Jemma V. Rowlands, MPH, New York State Department of Health; Chantelle Seaver, MS, New York State Department of Health; Kimberley A. Seward, MPH, New York State Department of Health; Lou Smith, MD, New York State Department of Health; Inderbir Sohi, MSPH, New York State Department of Health; Kirsten St. George, PhD, Wadsworth Center, New York State Department of Health; Maria I. Souto, MPH, Rockland County Department of Health; Rachel Elizabeth Wester, MPH, New York State Department of Health; Susan J. Wong, PhD, Wadsworth Center, New York State Department of Health; Li Zeng, Wadsworth Center, New York State Department of Health; Joel Ackelsberg, MD, New York City Department of Health & Mental Hygiene; Byron Alex, MD, New York City Department of Health & Mental Hygiene; Vennus Ballen, MD, New York City Department of Health & Mental Hygiene; Jennifer Baumgartner, MSPH, New York City Department of Health & Mental Hygiene; Danielle Bloch, MPH, New York City Department of Health & Mental Hygiene; Sandhya Clark, MPH, New York City Department of Health & Mental Hygiene; Erin Conners, PhD, New York City Department of Health & Mental Hygiene; Hannah Cooper, MBChB, New York City Department of Health & Mental Hygiene; Alexander Davidson, MPH, New York City Department of Health & Mental Hygiene; Catherine Dentinger, MS, MPH, New York City Department of Health & Mental Hygiene; Bisram Deocharan, PhD, New York City Department of Health & Mental Hygiene; Andrea DeVito, MPH, New York City Department of Health & Mental Hygiene; Jie Fu, PhD, New York City Department of Health & Mental Hygiene; Gili Hrusa, MPH, New York City Department of Health & Mental Hygiene; Maryam Iqbal, MS, New York City Department of Health & Mental Hygiene; Martha Iwamoto, MD, New York City Department of Health & Mental Hygiene; Lucretia Jones, DrPH, New York City Department of Health & Mental Hygiene; Hannah Kubinson, MPH, New York City Department of Health & Mental Hygiene; Maura Lash, MPH, New York City Department of Health & Mental Hygiene; Marcelle Layton, MD, New York City Department of Health & Mental Hygiene; Christopher T. Lee, MD, New York City Department of Health & Mental Hygiene; Dakai Liu, PhD, New York City Department of Health & Mental Hygiene; Emily McGibbon, MPH, New York City Department of Health & Mental Hygiene; Morgan Moy, MPH, New York City Department of Health & Mental Hygiene; Stephanie Ngai, MPH, New York City Department of Health & Mental Hygiene; Hilary B. Parton, MPH, New York City Department of Health & Mental Hygiene; Eric Peterson, MPH, New York City Department of Health & Mental Hygiene; Jose Poy, MPH, New York City Department of Health & Mental Hygiene; Jennifer Rakeman, PhD, New York City Department of Health & Mental Hygiene; Alaina Stoute, MPH, New York City Department of Health & Mental Hygiene; Corinne Thompson, PhD, New York City Department of Health & Mental Hygiene; Don Weiss, MD, New York City Department of Health & Mental Hygiene; Emily Westheimer, MSc, New York City Department of Health & Mental Hygiene; Ann Winters, MD, New York City Department of Health & Mental Hygiene; Mohammad Younis, MS, MPA, New York City Department of Health & Mental Hygiene; Ronna L. Chan, PhD, North Carolina Department of Health and Human Services, Division of Public Health; Laura Jean Cronquist, North Dakota Department of Health, Division of Disease Control; Lisa Caton, MS, Oklahoma State Department of Health; Leah Lind, MPH, Pennsylvania Department of Health; Kumar Nalluswami, MD, Pennsylvania Department of Health; Dana Perella, MPH, Philadelphia Department of Public Health; Diane S. Brady, MS, Rhode Island Department of Health; Michael Gosciminski, MPH, Rhode Island Department of Health; Patricia McAuley, MSN, Rhode Island Department of Health; Daniel Drociuk, MT, South Carolina Department of Health & Environmental Control, Division of Acute Disease Epidemiology; Vinita Leedom, MPH, South Carolina Department of Health & Environmental Control, Division of Maternal and Child Health; Brian Witrick, MPH, South Carolina Department of Health & Environmental Control, Division of Acute Disease Epidemiology; Jan Bollock, South Dakota Department of Health DIS; Marie Bottomley Hartel, MPH, Tennessee Department of Health; Loraine Swanson Lucinski, MPH, Tennessee Department of Health; Morgan McDonald, MD, Tennessee Department of Health; Angela M. Miller, PhD, Tennessee Department of Health; Tori Armand Ponson, MPH, Tennessee Department of Health; Laura Price, Tennessee Department of Health; Amy E. Nance, MPH, Utah Birth Defect Network, Utah Department of Health; Dallin Peterson, Utah Department of Health; Sally Cook, Vermont Department of Health; Brennan Martin, MPH, Vermont Department of Health; Hanna Oltean, MPH, Washington State Department of Health; Jillian Neary, MPH, Washington State Department of Health; Melissa A. Baker, MA, West Virginia Office of Maternal, Child and Family Health; Kathy Cummons, MSW, West Virginia Office of Maternal, Child and Family Health; Katie Bryan, MPH, Wyoming Department of Health; Kathryn E. Arnold, MD, CDC; Annelise C. Arth, MPH, CDC; Brigid C. Bollweg, MPH, CDC; Janet D. Cragan, MD, CDC; April L. Dawson, MPH, CDC; Amy M. Denison, PhD, CDC; Eric J. Dziuban, MD, CDC; Lindsey Estetter, MS, CDC; Luciana Silva-Flannery, PhD, CDC; Rebecca J. Free, MD, CDC; Romeo R. Galang, MD, CDC; Joy Gary, DVM, PhD, CDC; Cynthia S. Goldsmith, MGS, CDC; Caitlin Green, MPH, CDC; Gillian L. Hale, MD, CDC; Heather M. Hayes, CDC; Irogue Igbinosa, MD, CDC; M. Kelly Keating, DVM, CDC; Sumaiya Khan, MPH, CDC, ORISE; Shin Y. Kim, MPH, CDC; Margaret Lampe, MPH, CDC; Amanda Lewis, CDC; Cara Mai, PhD, CDC; Roosecelis Brasil Martines, MD, PhD, CDC; Brooke Miers, MS, CDC; Jazmyn Moore, MPH, CDC; Atis Muehlenbachs, MD, PhD, CDC; John Nahabedian, MS, CDC; Amanda Panella, MPH, CDC; Vaunita Parihar, CDC; Mitesh M. Patel, CDC; D. Brett Rabeneck, MS, CDC; Sonja A. Rasmussen, MD, CDC; Jana M. Ritter, DVM, CDC; Dominique C. Rollin, MD, CDC; Jeanine H. Sanders, CDC; Wun-Ju Shieh, MD, PhD, CDC; Regina M. Simeone, MPH, CDC; Elizabeth L. Simon, MPH, CDC; John R. Sims, CDC; Pamela J. Spivey, CDC; Helen Talley-McRae, CDC; Alphonse K. Tshiwala, MPA, CDC; Kelley VanMaldeghem, MPH, CDC; Laura Viens, MD, CDC; Anne Wainscott-Sargent, Carter Consulting; Tonya Williams, PhD, CDC; Sherif Zaki, MD, PhD, CDC; all of these individuals meet collaborator criteria.
  13. Conclusions and Comments The number of pregnant women with laboratory evidence of possible recent Zika virus infection and the number of fetuses/infants with Zika virus–associated birth defects continues to increase in the United States. The proportion of fetuses and infants with birth defects among pregnancies with confirmed Zika virus infection at any time during pregnancy was more than 30 times higher than the baseline prevalence in the pre-Zika years, and a higher proportion of those with first trimester infections had birth defects (4). Although microcephaly was the first recognized birth defect reported in association with congenital Zika virus infection, Zika virus–associated brain abnormalities can occur without microcephaly, and neuroimaging is needed to detect these abnormalities (9). Neuroimaging is also used in other congenital infections to identify brain abnormalities; for example, neuroimaging findings in infants with congenital cytomegalovirus infection are correlated with neurodevelopmental outcomes (10). Postnatal neuroimaging is recommended for all infants born to women with laboratory evidence of Zika virus infection to identify infants with brain anomalies that warrant additional evaluation to ensure that appropriate intervention is provided (8). Based on data reported to the USZPR, the majority of these infants had not received recommended neuroimaging. In addition to infants with birth defects, complete follow-up and routine developmental assessment of all infants born to women with laboratory evidence of possible recent Zika virus infection is essential to help identify future outcomes potentially associated with congenital Zika virus infection and ensure that the referrals to appropriate support and follow-up care are made. The findings in this report are subject to at least four limitations. First, selection bias might affect which pregnancies are reported to the USZPR, because pregnant women with symptoms of Zika virus disease might be more likely than asymptomatic women to be tested. Pregnant women with Zika virus exposure and prenatally detected fetal abnormalities or infants with birth defects might be more likely to be tested for Zika virus infection. In addition, pregnancies resulting in a loss might be more likely to have had a confirmed Zika virus infection and more likely to have the placenta or other pathologic specimens tested (11). However, it is also possible that birth defects in pregnancy losses, including stillbirths, have not been reported. Second, while CDC has worked closely with state and local health departments to obtain complete information, delays in reporting postnatal neuroimaging or infant Zika virus testing results are possible. In addition, some of the pregnancies included in the analysis were completed before CDC’s most recent infant guidance (8) was released, and thus, current recommendations for neuroimaging or testing might not have been implemented. Third, current testing methodologies are limited in that they can only identify recent Zika virus infections (5) and might miss those women who are tested when Zika virus RNA and/or IgM is no longer detectable; these pregnancies would not be included in the USZPR unless the fetus/infant or placenta has a positive Zika virus test result. Also, serologic testing cannot readily discriminate between flaviviruses because of crossreactivity (5); therefore, some pregnancies in the USZPR might have had a recent infection with a flavivirus other than Zika virus which could lead to an underestimate of the proportion of fetuses/infants affected. For this reason, in this report, analysis of the subset of pregnancies with laboratory-confirmed recent Zika virus infection was included. Finally, limited data are available about other maternal risk factors for birth defects, including genetic or other infectious causes, which might be causal factors for a few of the birth defects reported here. These findings underscore the serious risk for birth defects posed by Zika virus infection during pregnancy and highlight why pregnant women should avoid Zika virus exposure and that all pregnant women should be screened for possible Zika virus exposure at every prenatal visit, with testing of pregnant women and infants in accordance with current guidance (https://www.cdc.gov/zika/pdfs/zikapreg_screeningtool.pdf) (8,12). Zika virus testing of infants is recommended for 1) all infants born to women with laboratory evidence of Zika virus infection in pregnancy and 2) infants with findings suggestive of congenital Zika syndrome born to women with an epidemiologic link suggesting possible transmission, regardless of maternal testing results. Infants without abnormalities born to women with an epidemiological link suggesting possible Zika virus exposure during pregnancy, and for whom maternal testing was not performed or was performed more than 12 weeks after exposure, should have a comprehensive exam. If there is concern about infant follow-up or maternal testing is not performed, infant Zika virus testing should be considered. The initial evaluation of infants should include a comprehensive physical examination, including a neurologic examination, postnatal neuroimaging, and standard newborn hearing screen. Additional evaluation might be considered based on clinical and laboratory findings, however routine developmental assessment is recommended as part of pediatric care (8). Based on initial USZPR reports, most infants born to women with laboratory evidence of possible recent Zika virus infection during pregnancy might not be receiving the recommended evaluation (e.g., postnatal neuroimaging). CDC is working with public health officials, professional societies, and health care providers to increase awareness of and adherence to CDC guidance for the evaluation and management of infants with possible congenital Zika virus infection. Identification and follow-up care of infants born to mothers with laboratory evidence of possible recent Zika virus infection during pregnancy and infants with possible congenital Zika virus infection can ensure that appropriate intervention services are available to affected infants.
  14. Results From January 15 through December 27, 2016, a total of 1,297 pregnancies with possible recent Zika virus infection were reported to the USZPR from 44 states ( Figure 1), including 972 completed pregnancies with reported outcomes (895 liveborn infants and 77 pregnancy losses). Among the completed pregnancies, 599 (62%) pregnant women were asymptomatic, 348 (36%) were symptomatic, and 25 (3%) had missing symptom information ( Table 1). Birth defects were reported for 51 (5%) of the 972 completed pregnancies with laboratory evidence of possible recent Zika virus infection. The proportion was higher among completed pregnancies with confirmed Zika virus infection (24/250, 10%). Among completed pregnancies with confirmed Zika virus infection, 217 of 250 (87%) tested positive by RT-PCR, including 24 pregnancies with a fetus or infant with birth defects. Birth defects were reported in similar proportions of fetuses/infants whose mothers did and did not report symptoms of Zika virus disease during pregnancy. Brain abnormalities and/or microcephaly were reported in 43 (84%) of 51 fetuses/infants with birth defects. Among pregnancies with confirmed Zika virus infection, brain abnormalities and/or microcephaly were reported in 18 (75%) of 24 fetuses/infants with birth defects. The 51 fetuses or infants with birth defects were from pregnancies with Zika virus exposure from the following 16 countries/territories with active Zika virus transmission: Barbados, Belize, Brazil, Cape Verde, Colombia, Dominican Republic, El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Mexico, Puerto Rico, Republic of Marshall Islands, and Venezuela. Birth defects were reported in a higher proportion of fetuses or infants whose mothers were infected during the first trimester of pregnancy. Among 157 pregnancies in which women had symptom onset or exposure to Zika virus infection during the first trimester, 14 (9%) fetuses/infants had reported birth defects (Table 1). When pregnancies with symptom onset or exposure during first trimester were limited to those with laboratory-confirmed Zika virus infection, nine (15%) of 60 completed pregnancies had reported birth defects. Among the 895 liveborn infants, postnatal neuroimaging results were reported to the USZPR for 221 (25%). Zika virus testing results of any specimen were reported for 585 (65%) infants; 94 (11%) of all 895 liveborn infants had positive Zika virus test results. Among the 45 liveborn infants with birth defects, 25 (56%) had positive infant Zika virus testing results reported, and 29 (64%) had postnatal neuroimaging reported to the USZPR ( Table 2). Among the 850 liveborn infants without birth defects, 69 (8%) had positive infant Zika virus testing results reported, and 192 (23%) had postnatal neuroimaging reported to the USZPR. The percentage of infants reported to have received postnatal neuroimaging was 20% among 406 born through August 2016, and 28% among 489 born during September–December 2016, after the updated CDC guidance was released (8) ( Figure 2).