Health Highlights: Nov. 25, 2013

Health Highlights: Nov. 25, 2013

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

FDA Tells Gene Testing Company to Halt Marketing

A company that offers genetic testing directly to consumers has been told to stop marketing its main DNA service until it receives approval from the U.S. Food and Drug Administration.

An FDA warning letter sent to Califoria-based 23andMe says the company has failed to provide adequate evidence that its Personal Genome Service provides accurate results. The letter was issued Friday and posted on the FDA's website Monday, The New York Times reported.

The letter says the agency considers the service to be a medical device that requires approval.

"FDA is concerned about the public health consequences of inaccurate results from the PGS device," the letter states. "The main purpose of compliance with FDA's regulatory requirements is to ensure the tests work."

23andMe's service has been used by about half a million people. It claims to tell consumers whether they might be at increased or decreased risk for various diseases, among other things, The Times reported.

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Ultrasound Scan for Liver Tumors Cuts Kids' Exposure to Radiation: Study

Using an new ultrasound technique to look for dangerous tumors in children's livers could reduce their exposure to radiation, according to U.K. researchers.

A CT scan can tell the difference between benign growths and malignant tumors in a child's liver, but the test results in radiation exposure.

"We are trying to stop children having unnecessary radiation as the long-term effects show a substantial increase in cancer," Professor Paul Sidhu, a consultant radiologist at King's College Hospital in London, told BBC News.

He and his colleagues are testing a new method of ultrasound that has been used for a decade in adults but not in children. A harmless chemical that's injected into the body forms temporary microscopic bubbles in the bloodstream and acts as a contrast agent for the ultrasound.

"It makes the arteries light up and then the veins and the whole liver. It looks like a field of gold," Sidhu said. If the liver tumor is benign, it lights up like the rest of the liver, but a cancerous tumor will rapidly get rid of the contrast agent, BBC News reported.

The researchers tested the new method on 44 children with chronic liver problems and found that it provided accurate diagnoses. However, further studies involving thousands of patients are needed to confirm the study findings, which were published in the European Journal of Ultrasound.

FDA Approves Bird Flu Vaccine

On Friday, the U.S. Food and Drug Administration approved a vaccine to prevent H5N1 influenza, known as avian or bird flu. The vaccine will not be commercially available but will be added to the nation's anti-flu stockpile. It's specifically meant for use in people aged 18 and older at increased risk for H5N1 virus exposure.

Bird flu is typically spread among poultry infected by certain influenza A viruses. Outside the United States, however, there have been cases when people in close contact with infected poultry have died or become severely ill. About 60 percent of infected people die, according to the World Health Organization. Because wild birds continue to be infected, the potential for a human pandemic exists, according to an FDA news release.

"This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the news release.

The new vaccine is called Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted. It contains an oil-in-water emulsion -- the adjuvant. Adjuvants enhance or direct the immune response of the person receiving the vaccination. The vaccine is made by ID Biomedical Corporation of Quebec (a division of GlaxoSmithKline Biologicals). It will be included in the Strategic National Stockpile to be distributed by U.S. public health officials if needed.

 
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