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  3. Tonight at 10 PM - Personal DNA Testing THURSDAY Dr. Henry L. Niman, PhD
  4. Report date : 2017-04-20 16:27:01 Country : Poland Disease: : Highly path. avian influenza View the full article
  5. Report date : 2017-04-20 17:32:44 Country : Slovakia Disease: : Highly path. avian influenza View the full article
  6. Report date : 2017-04-20 15:45:29 Country : Korea (Rep. of) Disease: : Highly path. avian influenza View the full article
  7. Report date : 2017-04-20 13:54:42 Country : Romania Disease: : Newcastle disease View the full article
  8. On 14 April 2017, the National Health and Family Planning Commission of China (NHFPC) notified WHO of 15 additional laboratory-confirmed cases of human infection with avian influenza A(H7N9) virus in mainland China. View the full article
  9. Report date : 2017-04-20 13:30:30 Country : Russia Disease: : Highly path. avian influenza View the full article
  10. 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
  11. 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.
  12. Report date : 2017-04-19 16:14:28 Country : France Disease: : Highly path. avian influenza View the full article
  13. Report date : 2017-04-19 14:27:59 Country : Kuwait Disease: : Highly path. avian influenza View the full article
  14. Report date : 2017-04-19 14:22:36 Country : Vietnam Disease: : Highly path. avian influenza View the full article
  15. Report date : 2017-04-18 18:18:39 Country : Japan Disease: : Highly path. avian influenza View the full article
  16. On 7 April 2017, the National Health and Family Planning Commission of China (NHFPC) notified WHO of 14 additional laboratory-confirmed cases of human infection with avian influenza A(H7N9) virus in mainland China. View the full article
  17. Report date : 2017-04-18 14:33:41 Country : Japan Disease: : Highly path. avian influenza View the full article
  18. Report date : 2017-04-18 14:39:32 Country : Romania Disease: : Highly path. avian influenza View the full article
  19. Report date : 2017-04-13 00:00:00 Country : Czech Republic Disease: : Highly path. avian influenza View the full article
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  21. Report date : 2017-04-14 16:11:11 Country : France Disease: : Low pathogenic avian influenza (poultry) View the full article
  22. 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
  23. 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
  24. 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
  25. Report date : 2017-04-14 15:09:29 Country : Cameroon Disease: : Highly path. avian influenza View the full article
  26. 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
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