Susan Atkins, a WSGSC Family Advocate from Washington was invited to the White House to help celebrate the 20th anniversary of the passage of the Americans with Disabilities Act. For more information including pictures of the celebration, please click here.
On Tuesday, July 19, the NIH announced two grant programs for newborn screening research. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Diabetes and Digestive Kidney Disease, and National Institute on Deafness and Other Communication Disorders jointly issued a funding opportunity announcement (FOA) for an R21 program. A grant through the program will support research regarding therapeutic solutions for currently screened conditions and “high-priority” genetic diseases, which may be part of newborn screening in the near future. The grants will provide up to $275,000 for research projects, which can span a maximum of two years. For more information about this grant opportunity, go to: http://grants.nih.gov/grants/guide/pa-files/PAR-10-232.html
The NIH also issued an FOA for an R03 program, which will also fund research relevant to therapeutic solutions for currently screened and “high-priority” conditions. The grant program can provide funds for different types of research, including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 program provides grants for institutions with limited resources to carry out smaller projects over a shorter period of time. Both grants will also support research about genetic risk factors and the relationship between phenotype and genotype. For more information about this funding opportunity, go to: http://grants.nih.gov/grants/guide/pa-files/PAR-10-231.html
On July 19th, the Food and Drug Administration (FDA) mailed letters to 14 providers of genetic tests. These companies include:
- Graceful Earth Inc. Concerning the Graceful Earth Alzheimer’s Test
- SeqWright DNA Technology Services, Inc. Concerning the SeqWright Genomic Profiling Service (GPS)
- Interleukin Genetics, Inc. Concerning the Inerent Health
- DNATraits Concerning the Ashkenazi Jews Genetic Disease Panel
- CyGene Direct™ Concerning the Metabolic Health Assessment DNA Analysis Test
- Consumer Genetics, LLC Concerning the AsthmaGEN DNA Test
- Matrix Genomics, Inc. Concerning the Matrix Genomics Breast Cancer Panel
- The Genetic Testing Laboratories, Inc. Concerning The Genetic Testing Laboratories DNA Predisposition Test
- Sequenom, Inc. Concerning the SEQureDx™
- EnteroLab Reference Laboratory Concerning the Gene Test for Gluten Sensitivity/Celiac Sprue
- BioMarker Pharmaceuticals, Inc. Concerning the Gene Essence™
- DNA Dimensions Concerning the Predisposition DNA Test
- HealthCheckUSA Concerning the HealthCheckUSA Celiac Disease DNA Test
- easyDNA Concerning the Genetic Predisposition Health Test
These letters were similar to those sent to five companies (3andMe, Navigenics, deCODE Genetics, Knome, and Illumina) in early June. In general, the letters stated that each of the companies is marketing a genetic test that, according to the FDA, meets the definition of a “device” under Section 201(h) of the Federal Food Drug and Cosmetic Act (FFDCA). Therefore, each test must receive FDA clearance (510(k)) or approval (PMA). The companies are asked to respond to the FDA within 15 days.
Beginning on July 19th, the FDA also held a two-day public meeting to discuss its planned regulation of laboratory developed tests which include direct to consumer genetic testing. For more information about the two-day meeting, go to: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm
Finally, the House Subcommittee on Oversight and Investigations held a hearing entitled “Direct-To-Consumer Genetic Testing and the Consequences to the Public Health,” on Thursday, July 22, 2010. The hearing examined the sale of direct-to-consumer personal genetic tests. For more information about this hearing, go to:http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2083:hearing-on-direct-to-consumer-genetic-testing-and-the-consequences-to-the-public-health&catid=133:subcommittee-on-oversight-and-investigations&Itemid=73
The 16th annual American Telemedicine Association’s International Meeting and Exposition will be held May 1-3, 2011 in Tampa, Florida. This conference is the largest international meeting and tradeshow focusing exclusively on telemedicine, telehealth, and remote medical technologies.
Call for Presentations opened July 15, and abstract proposals will be accepted through September 15, 2010. Abstracts are welcome on any topic relating to telemedicine and telehealth, however, abstracts that focus on outcomes and evidence, best practices and emerging applications for telemedicine and telehealth are of particular interest and will be highlighted in the 2011 program. For more information about the meeting or about submitting an abstract, go to: http://www.americantelemed.org/i4a/pages/index.cfm?pageID=3773
The CDC’s 4th National Conference on Genomics and Public Health is a 3-day event that will highlight best practices in public health genomics today while preparing for the future. The conference will be held December 8-10, 2010 in Bethesda, Maryland.
Researchers, practitioners, policy makers, educators, and representatives from academia, government, health care, public health, industry, community, and consumer groups are invited to submit abstracts for oral and poster presentation. Abstracts will be accepted between August 1-31, 2010. For more information about the meeting or about submitting an abstract, go to: http://www.cdc.gov/genomics/events/conference/2010-12_NatConf.htm
This year’s Maternal and Child Health Federal/State Partnership Meeting will commemorate the 75th anniversary of Title V of the Social Security Act. The meeting will be held on Wednesday, October 20th at the Hilton Washington in Washington DC. There is no registration fee to attend the meeting, but space is limited, so please submit your registration early to reserve a space. Registrations will be accepted through August 31, 2010. For more information including instructions on how to register for the meeting, go to: http://www.blsmeetings.net/mch75thanniversary/