Mineral Wells Index, Mineral Wells, TX

Community News Network

December 11, 2013

Personal genetic tests face sharper scrutiny after 23andMe

WASHINGTON — 23andMe Inc.'s clash with U.S. regulators over the direct sale of its gene analysis service to consumers signals stiffer oversight of thousands of tests in an industry predicted to increase fivefold in size.

The Personal Genome Test from Google-backed 23andMe gives individuals an analysis of their risk of hundreds of diseases based on DNA data. The Food and Drug Administration's action last month to ban sales of the service suggests the agency is expanding its focus to tests it hadn't regulated, said Jeff Gibbs, an attorney with Hyman Phelps & McNamara in Washington.

Genetic tests are in increasing demand to diagnose or determine disease risk and help make treatment decisions, especially in cancer. Increased regulation is needed to make sure tests like 23andMe's fulfill their claims, said James Evans, a geneticist at the University of North Carolina in Chapel Hill.

"These tests should ultimately have to prove themselves," Evans said in a telephone interview. "They should be forced to gather the evidence that backs up those claims."

Genetic analysis of sick and healthy individuals poses new challenges to insurers and government health programs such as Medicare that pay for medical care. UnitedHealth Group Inc., the biggest U.S. health insurer, said last year that it expects national annual spending on genetic tests to increase fivefold over the next decade to $25 billion.

The industry includes companies such as closely held San Diego-based Pathway Genomics Inc., which was cautioned by the FDA about giving estimates of genetic risk of disease directly to consumers, and now provides them through doctors. A large part of the industry isn't tightly overseen by the agency, including Salt Lake City-based Myriad Genetics Inc., among the biggest providers of genetic breast and ovarian cancer diagnostic services, and many smaller laboratories, such as closely held Ambry Genetics Corp., that offer a variety of genetic tests.

23andMe, based in Mountain View, Calif., said in a statement on its website that the company is committed to working with the FDA to address the agency's concerns. While all marketing of the Personal Genome stopped almost two weeks ago, and 23andMe halted sales of health-related data Dec. 5, some customers said the FDA is interfering with their access to personal health information.

"I want to know my own biology; it's my right," said Lynn Fellman, a multimedia artist in Washington who signed up two years ago with 23andMe. "With 23andMe, I don't have to go to the medical establishment to get this information."

Other clients say 23andMe misled them about the accuracy and validity of its test. A complaint filed Nov. 27 in federal court in San Diego seeks $5 million, saying the Personal Genome Service advertised medical claims without getting appropriate FDA authorization.

The FDA's wider purview may include laboratory developed tests, Gibbs said. These tests examine genes or groups of genes for signs of damage and dangerous inborn variations. Manufacturers typically seek FDA marketing clearance for tests that determine whether a person's cancer is treatable by a certain drug. For example, doctors prescribe skin cancer treatment with Roche Holding's Zelboraf after the patient undergoes an FDA-approved test for a certain mutation in the BRAF gene.

Many labs, however, have developed tests that aren't FDA- approved. Some of the more controversial tests use proprietary formulas to suggest whether cancer patients should receive certain treatments, such as harsher forms of radiation or chemotherapy. FDA Commissioner Margaret Hamburg said in June the agency is working to ensure the validity and accuracy of "'high-risk'' laboratory tests.

''It's an issue that's been percolating for years," Gibbs said in a telephone interview. "This is the policy issue that's most in people's minds."

There are about 3,000 laboratory-developed tests available, and most are monitored by the Centers for Medicare & Medicaid Services, rather than the FDA. CMS requires laboratories only show that the tests are accurate and repeatable, not that they contribute to patient care, as FDA reviews do.

The FDA is preparing guidance for regulating laboratory tests, which is currently in administrative review, Susan Laine, an agency spokeswoman, said in an email. Laine wouldn't say what further action the agency might take in the testing area.

The FDA last month gave its first approval for medical use of next-generation sequencing machines, which laboratories increasingly use to decipher swatches of DNA. One of the approved machines is a product from San Diego-based Illumina Inc., the biggest maker of sequencers, that helps laboratories develop tests for specific medical purposes.

23andMe's direct-to-consumer approach bears little resemblance to laboratory tests that are normally ordered and interpreted by physicians, said Alan Mertz, president of the American Clinical Laboratory Association, an industry group based in Washington.

The FDA doesn't have the authority to regulate laboratory tests, Mertz's group said in a citizen's petition in June. In addition, reining in laboratory tests would stand in the way of patient care, because gaining approval would be too expensive and laborious, the petition said.

The tests "will never generate the financial returns needed to justify the costs of obtaining FDA clearance or approval," the petition said. "Patients served by these tests would be left with no testing options."

1
Text Only
Community News Network
  • Fast food comes to standstill in China

    The shortage of meat is the result of China's latest food scandal, in which a Shanghai supplier allegedly tackled the problem of expired meat by putting it in new packaging and shipping it to fast-food restaurants around the country

    July 28, 2014

  • wd saturday tobias .jpg Stranger’s generosity stuns Ohio veteran

    Vietnam War veteran David A. Tobias was overwhelmed recently when a fellow customer at an OfficeMax store near Ashtabula, Ohio paid for a computer he was purchasing.

    July 28, 2014 1 Photo

  • Screen Shot 2014-07-28 at 1.33.11 PM.png VIDEO: High-dive accident caught on tape

    A woman at a water park in Idaho leaped off a 22-foot high dive platform, then tried to pull herself back up with frightening results. Fortunately, she escaped with only a cut to her finger.

    July 28, 2014 1 Photo

  • CATS-DOGS281.jpg Where cats are more popular than dogs in the U.S.-and all over the world

    We all know there are only two types of people in the world: cat people and dog people. But data from market research firm Euromonitor suggest that these differences extend beyond individual preferences and to the realm of geopolitics: it turns out there are cat countries and dog countries, too.

    July 28, 2014 1 Photo

  • How spy agencies keep their 'toys' from law enforcement

    A little over a decade ago, federal prosecutors used keystroke logging software to steal the encryption password of an alleged New Jersey mobster, Nicodemo Scarfo Jr., so they could get evidence from his computer to be used at his trial.

    July 25, 2014

  • 072214 Diamond Llama 1.jpg Llama on the loose corralled in Missouri town

    A llama on the lam cruised Main Street Tuesday before it mistook a resident’s fenced backyard for a place to grab a meal and freshen up.

    July 22, 2014 2 Photos

  • Wal-Mart to cut prices more aggressively in back-to-school push

    Wal-Mart Stores plans to cut prices more aggressively during this year's back-to-school season and will add inventory to its online store as the chain battles retailers for student spending.

    July 21, 2014

  • The terrible history of passenger planes getting shot out of the sky

    What is more clear is that, if initial reports are true, this would be the deadliest incident of a civilian passenger plane being shot down in modern memory. In some instances, the causes of the disaster are still shrouded in mystery. Here are some of the worst events.

    July 17, 2014

  • 20110929_bowling.jpg Why fewer people go bowling

    Like other industries facing tough economic times, America's bowling centers are trying to reinvent themselves.

    July 15, 2014 1 Photo

  • NWS-HB0713-HowardMartin-004.jpg Airman laid to rest back home in Indiana six decades after death

    The mystery of what happened to a military transport plane that disappeared in the fall of 1952 into an Alaskan glacier was solved two years ago when a helicopter crew spotted the wreckage. But it took another two years to retrieve the remains of Airman Howard Miller and 16 other servicemen passengers. Saturday, Miller was laid to rest in his hometown of Elwood, Ind., with full military honors. Hundreds turned out for the funeral and burial services.

    July 13, 2014 2 Photos

Featured Ads
Poll

Would you be in favor of or opposed to housing at the closed CCA facility at Wolters Industrial Park some of the unaccompanied children who have crossed illegally into the U.S. and Texas?

In favor
Opposed
Not sure/undecided
Don't care
     View Results
Mineral Wells Index


Click on a photo to visit our SmugMug page

Front page
Weather Underground Radar
Twitter Updates
Follow us on twitter
AP Video
Kerry: Humanitarian Cease-fire Efforts Continue Raw: Corruption Trial Begins for Former Va Gov. The Carbon Trap: US Exports Global Warming UN Security Council Calls for Gaza Cease-fire Traditional African Dishes Teach Healthy Eating 13 Struck by Lightning on Calif. Beach Baseball Hall of Famers Inducted Israel, Hamas Trade Fire Despite Truce in Gaza Italy's Nibali Set to Win First Tour De France Raw: Shipwrecked Concordia Completes Last Voyage Raw: Sea Turtle Hatchlings Emerge From Nest Raw: Massive Dust Storm Covers Phoenix 12-hour Cease-fire in Gaza Fighting Begins Raw: Bolivian Dancers Attempt to Break Record Raw: Israel, Palestine Supporters Rally in US Raw: Air Algerie Flight 5017 Wreckage Virginia Governor Tours Tornado Aftermath Judge Faces Heat Over Offer to Help Migrant Kids Kangaroo Goes Missing in Oklahoma More M17 Bodies Return, Sanctions on Russia Grow
Must Read
Seasonal Content
Parade
Magazine

Click HERE to read all your Parade favorites including Hollywood Wire, Celebrity interviews and photo galleries, Food recipes and cooking tips, Games and lots more.
Stocks
Hyperlocal Search
Premier Guide
Find a business

Walking Fingers
Maps, Menus, Store hours, Coupons, and more...
Premier Guide