Health Highlights: Feb. 20, 2015

• Tweet
• Pin It

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

Public Access to Genetic Tests Made Easier by FDA

Americans will soon have easier access to DNA screening tests for serious genetic disorders that can be inherited by their children.

On Thursday, the U.S. Food and Drug Administration said no preliminary review will be required before companies can sell what are known as carrier screening tests directly to the public. The tests — currently given by health care professionals — are used by healthy adults who may be carriers of severe genetic disorders such as cystic fibrosis and Tay-Sachs, the Associated Press reported.

The FDA also announced that it authorized the first direct-to-consumer carrier screening test from California-based genetic testing firm 23andMe, which was forced to remove its DNA tests from the market in 2013 due to a lack of scientific proof.

The test from 23andMe screens for genetic mutations behind a rare inherited disorder called Bloom syndrome, which causes short stature, increased risk of cancer and a number of other health problems. The disorder affects about 1 in 50,000 people, the AP reported.

Thursday’s FDA announcement means that another 45 to 50 carrier screening tests made by 23andMe could be sold directly to the public, possibly by later this year, according to company CEO Anne Wojcicki.

She said her company’s research shows that the general public can understand genetic test results.

“Our user comprehension studies have shown that people can get this information on their own without a physician and that there’s potentially a real benefit to direct access,” Wojcicki told the AP.

A notice of change about the genetic screening test regulations will be filed by the FDA and the agency will accept public comments for 30 days.

“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” said Alberto Gutierrez, director of FDA’s office for diagnostics, the AP reported.

—–

Rapid Ebola Test Approved by WHO

A 15-minute blood test for Ebola approved by the World Health Organization could help end the outbreak in West Africa by enabling health care workers to more rapidly identify, isolate and treat people with the deadly infectious disease.

The first rapid blood test for Ebola is less accurate than conventional tests, but trials in West Africa indicate the new test correctly identifies about 92 percent of people with Ebola, BBC News reported.

Also, the new test works without electricity, which means it can be used in remote areas.

Current Ebola testing analyzes the blood for fragments of Ebola’s genetic material and requires a laboratory and can take between 12 and 24 hours to provide results, BBC News reported.

The new ReEBOV Antigen Rapid Test analyzes the blood for a different part of the virus. The test was developed by U.S. company Corgenix.

“While less accurate, the antigen test is rapid, easy to perform and does not require electricity,” the WHO said. “It can therefore be used at lower health care facilities or in mobile units for patients in remote settings.”

Where possible, results from the rapid test should be confirmed by conventional testing, the agency added.

“The new test could help to quickly confirm outbreaks in remote areas without the need to send samples to a testing clinic and wait for results,” Dr Ben Neuman, a virology expert at the University of Reading in the U.K., told BBC News.

“The new test isn’t about saving the lives of infected people, but it can help in the long run by making it easier and quicker to detect Ebola outbreaks,” he added.

More than 23,250 people have been infected in the Ebola outbreak in West Africa and 9,380 have died.

Copyright © 2024 HealthDay. All rights reserved.

• Tweet
• Pin It