Bowing to the Food and Drug Administration, the genetic testing service 23andMe said Thursday that it would stop providing consumers with health information while its test undergoes regulatory review.
The decision was in response to a warning letter sent by the agency two weeks ago saying that the genetic test was a medical device that requires approval.
“We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives,” Anne Wojcicki, the chief executive of 23andMe, said in a statement Thursday evening.
“Our goal is to work cooperatively with the F.D.A. to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”
The company will continue to take orders for new tests but will provide only ancestry information and raw data, without interpretations of the health implications. It said it might resume providing health data if it receives regulatory approval.
23andMe sought approval of certain of its tests in 2012 but did not provide information the F.D.A. required. After the company began advertising on television, the agency ordered it to stop marketing its test.
The company then halted advertising, apparently hoping that it could stop “marketing” but continue selling. But it appears that regulators did not buy that...
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Showing posts with label genetic testing. Show all posts
Showing posts with label genetic testing. Show all posts
Friday, December 6, 2013
Genetic Tester to Stop Providing Data on Health Risks
Tuesday, December 4, 2012
Obesity Is Weighing Down The Workers' Compensation System
The "fat" gene |
Medical delivery now needs to deal with: weight reduction, delay of medical care and complex treatment protocols , due obesity issues. The resulting consequences of this pre-existing / coexisting issues, are increasing the economic burden on the entire program.
Recent discoveries in human genome project reflect that obesity may actually be controlled by genetic propensities. In other words, the so-called "fat gene" programs whether the human body will gain weight.
"Obesity is a chronic metabolic disorder affecting half a billion people worldwide. Major difficulties in managing obesity are the cessation of continued weight loss in patients after an initial period of responsiveness and rebound to pretreatment weight. It is conceivable that chronic weight gain unrelated to physiological needs induces an allostatic regulatory state that defends a supranormal adipose mass despite its maladaptive consequences. To challenge this hypothesis, we generated a reversible genetic mouse model of early-onset hyperphagia and severe obesity by selectively blocking the expression of the proopiomelanocortin gene (Pomc) in hypothalamic neurons. Eutopic reactivation of central POMC transmission at different stages of overweight progression normalized or greatly reduced food intake in these obesity-programmed mice. Hypothalamic Pomc rescue also attenuated comorbidities such as hyperglycemia, hyperinsulinemia, and hepatic steatosis and normalized locomotor activity. However, effectiveness of treatment to normalize body weight and adiposity declined progressively as the level of obesity at the time of Pomcinduction increased. Thus, our study using a novel reversible monogenic obesity model reveals the critical importance of early intervention for the prevention of subsequent allostatic overload that auto-perpetuates obesity."
Workers' Compensation needs to address obesity as a medical condition requiring, not only with co-existence medical attention, but also extend preventive medical treatment and medical monitoring to that the conditio Then obesity will not become a major factor in an employee's lifetime. Identification of this genetic abnormality early on appears critical to addressing weight control and behavior leading to its elimination.
This is yet another reason why the incorporation of the workers' compensation program into a universal medical system is so very important to the health of workers, and the solvency of workers compensation going forward.
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Jon L.Gelman of Wayne NJ, helping injured workers and their families for over 4 decades, is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson).
Read more about obesity and workers' compensation
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We thought it was a fitting topic for our workers' law blog because NFL linemen must embrace this condition in order to stay in peak performance. It's called chronic obesity. These days, to be an NFL lineman, you not only have ...
Nov 15, 2012
In 2010, an NCCI study found that claims with an obesity comorbidity diagnosis incurred significantly higher medical costs than comparable claims without such a comorbidity diagnosis. Relative to that study, this study ...
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