How the FDA Weighs in on DNA Tests
As genomics becomes relevant to medical care, regulatory agencies like the FDA are going to be watching this and making sure it’s being done properly.
Dr. Green is the director of the National Human Genome Research Institute, one of the 27 institutes and centers that make up the U.S. National Institutes of Health, the federal agency that funds and conducts medical research. The NIH Intramural Sequencing Center is a lab that Dr. Green founded and which is part of the National Human Genome Research Institute.
Prior to this appointment, he was the Scientific Director of NHGRI, a position he held since 2002. In addition, Green serves as chief of the NHGRI Genome Technology Branch (since 1996) and director of the NIH Intramural Sequencing Center (NISC) (since 1997).
Genomics is finding its way into the news increasingly and part of the reason for that, of course, is because genomics is becoming very relevant for medical care. For example, the Food and Drug Administration - which oversees many of the things that come into clinical care - has gotten involved in a couple of ways.
One of the things they did was to "clear" – in other words, approve the use of one of these fancy new methods for sequencing DNA for clinical use. These new technologies that allow you to sequence a human genome very inexpensively – the FDA now has given clearance for its use under certain clinical situations. And then similarly the FDA is carefully watching what’s going on with some genomic testing companies, in particular some companies that are called direct to consumer companies.
These are companies where they don’t have a health care professional in the middle ordering the test. Rather, consumers order it on themselves. They send in a little DNA sample by spitting in a tube and then genomic information about the individual is obtained and then given back to that individual.
The FDA is establishing exactly what they want to be doing to make sure that this is done in an appropriate fashion. And they sent out some warnings to one of the companies and are now interacting with them to make sure that they get the information that they need in order to make sure appropriate tests are being done and they’re appropriately validated and et cetera and so forth.
I think we’re going to see a lot more of this because as genomics becomes relevant to medical care, regulatory agencies like the FDA are going to be watching this and making sure it’s being done properly.
In Their Own Words is recorded in Big Think's studio.
Image courtesy of Shutterstock
The ability to speak clearly, succinctly, and powerfully is easier than you think
The ability to communicate effectively can make or break a person's assessment of your intelligence, competence, and authenticity.
Antimicrobial resistance is growing worldwide, rendering many "work horse" medicines ineffective. Without intervention, drug-resistant pathogens could lead to millions of deaths by 2050. Thankfully, companies like Pfizer are taking action.
- Antimicrobial-resistant pathogens are one of the largest threats to global health today.
- As we get older, our immune systems age, increasing our risk of life threatening infections. Without reliable antibiotics, life expectancy could decline for the first time in modern history.
- If antibiotics become ineffective, common infections could result in hospitalization or even death. Life-saving interventions like cancer treatments and organ transplantation would become more difficult, more often resulting in death. Routine procedures would become hard to perform.
- Without intervention, resistant pathogens could result in 10 million annual deaths by 2050.
- By taking a multi-faceted approach—inclusive of adherence to good stewardship, surveillance and responsible manufacturing practices, as well as an emphasis on prevention and treatment—companies like Pfizer are fighting to help curb the spread.
Progressive America would be half as big, but twice as populated as its conservative twin
- America's two political tribes have consolidated into 'red' and 'blue' nations, with seemingly irreconcilable differences
- Perhaps the best way to stop the infighting is to go for a divorce – and give the two nations a country each
- Based on the UN's partition plan for Israel/Palestine, this proposal provides territorial contiguity and sea access to both 'red' and 'blue' America
SMARTER FASTER trademarks owned by The Big Think, Inc. All rights reserved.