HANG LUNG 1H UNDERLYING PROFIT HK$2.5B; ANALYST EST. HK$2.4B
By Anna Edney - 2012-07-30T18:47:12Z
23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, sought U.S. regulatory approval for a genetic testing service that may help people assess their risk for developing cancer and Alzheimers.
The submission with the Food and Drug Administration will cover seven tests, which 23andMe isnt specifying, Ashley Gould, the Mountain View, California-based companys chief legal officer, said today in a phone interview. The tests are part of a service that tells users whether they carry a disease, are at risk of a disease and would respond to a drug, she said.
The result that you get when you review a report, the FDA wants to ensure thats a valid result, Gould said.
Wojcicki, the wife of Google co-founder Sergey Brin, started 23andMe about six years ago, and her husband used the saliva kit to determine he had a gene that makes him susceptible to developing Parkinsons. The FDA decided in 2010 that services claiming to evaluate a customers risk of disease must be cleared by regulators if the companies sell directly to consumers.
23andMe is working proactively with the FDA to ensure the industry delivers high quality information that consumers can trust, Wojcicki said in a statement on the companys website.
Such types of genetic tests may become a $25 billion annual market in the U.S. within a decade, highlighting the need to identify which work best, UnitedHealth Group Inc. (UNH), the largest publicly traded U.S. health insurer, has said. While UnitedHealth said such tests hold great promise, the insurer in a March report raised concern about accuracy and affordability.
23andMe said it submitted the FDA application today for the least stringent of two types of medical device reviews. The company plans to submit several more applications by the end of this year, Gould said.
DNA Genotek Inc. (OSUR), a company bought last year by OraSure Technologies Inc., makes the FDA-approved saliva kit. Gould said 23andMe is seeking approval of the process for analyzing and interpreting DNA results for patients.
Read the original post:
Google-Backed 23andMe Asks FDA to Clear DNA Evaluation Service
- Molecular Visualizations of DNA - August 27th, 2011 [August 27th, 2011]
- DNA Structure - August 27th, 2011 [August 27th, 2011]
- Time Is Money Presents: Dna vs. T-rex - August 27th, 2011 [August 27th, 2011]
- DNA Replication Process - August 27th, 2011 [August 27th, 2011]
- darwin deez - dna (official video) - August 27th, 2011 [August 27th, 2011]
- The Secret of Life -- Discovery of DNA Structure - August 27th, 2011 [August 27th, 2011]
- DNA - Blonde Red Head (from Downtown 81) - August 27th, 2011 [August 27th, 2011]
- How Big is Your Genome? Strange DNA - August 27th, 2011 [August 27th, 2011]
- DNA live - August 27th, 2011 [August 27th, 2011]
- Amanda Knox's father says DNA evidence 'critical' - September 11th, 2011 [September 11th, 2011]
- Judge: No more DNA testing in Amanda Knox appeal - September 11th, 2011 [September 11th, 2011]
- NASA | DNA Building Blocks Can Be Made in Space - September 11th, 2011 [September 11th, 2011]
- Starchild Skull- The SHOCKING DNA Results Are In....WATCH THIS! *HD* - September 11th, 2011 [September 11th, 2011]
- Svante Pääbo: DNA clues to our inner neanderthal - September 11th, 2011 [September 11th, 2011]
- CIA may have tried 'to trick DNA from Bin Laden' - September 11th, 2011 [September 11th, 2011]
- SMACK/ URL Presents DNA vs X-Factor - September 11th, 2011 [September 11th, 2011]
- Court denies re-test of DNA in Amanda Knox trial - September 11th, 2011 [September 11th, 2011]
- Chapter 10: Tenacious DNA - September 23rd, 2011 [September 23rd, 2011]
- dna - September 23rd, 2011 [September 23rd, 2011]
- Saul Williams - DNA - September 23rd, 2011 [September 23rd, 2011]
- DNA--Not Moving - September 23rd, 2011 [September 23rd, 2011]
- DNA Extraction Home Experiment - September 23rd, 2011 [September 23rd, 2011]
- How to extract DNA from strawberries - September 23rd, 2011 [September 23rd, 2011]
- frequency 528 Hz (DNA repair frequency ?) : NO MUSIC single tone - September 23rd, 2011 [September 23rd, 2011]
- darwin deez - dna [director's cut] - September 23rd, 2011 [September 23rd, 2011]
- DNA Replication Song - September 23rd, 2011 [September 23rd, 2011]
- BioRap (DNA Replication and Protein Synthesis with a Beat) - September 23rd, 2011 [September 23rd, 2011]
- DNA Transcription and Protein Assembly - September 23rd, 2011 [September 23rd, 2011]
- 888 Gateway DNA Meditation - September 23rd, 2011 [September 23rd, 2011]
- From DNA to Protein - September 23rd, 2011 [September 23rd, 2011]
- Blame it on the DNA - September 24th, 2011 [September 24th, 2011]
- DNA Replication - September 24th, 2011 [September 24th, 2011]
- Recombinant DNA ©2004 Demonstratives, Inc. - September 24th, 2011 [September 24th, 2011]
- A Flock of Seagulls - DNA - September 24th, 2011 [September 24th, 2011]
- DNA - Detached (from Downtown 81) - September 24th, 2011 [September 24th, 2011]
- Aliens, UFOs, DNA - September 25th, 2011 [September 25th, 2011]
- DNA Speaks On Recent Battles And X-Factor - September 25th, 2011 [September 25th, 2011]
- The DNA of the World's Most Innovative Companies - September 25th, 2011 [September 25th, 2011]
- Anunnaki Human DNA 1 - September 25th, 2011 [September 25th, 2011]
- Host DNA Dicing - Green Phat Bet - 11bill+ Total - - September 25th, 2011 [September 25th, 2011]
- Judge Alex - DNA Test - September 25th, 2011 [September 25th, 2011]
- Prosecution downplays DNA in Knox appeal - September 26th, 2011 [September 26th, 2011]
- NASA officially announces alien DNA found in meteorites. - September 26th, 2011 [September 26th, 2011]
- Antimatter Found, Artificial DNA ,Social Unrest - September 26th, 2011 [September 26th, 2011]
- Chrono Khalid - DNA activation 2.0 - September 26th, 2011 [September 26th, 2011]
- 'Baby' Alien found by farmer in Mexico - DNA tests and scans baffles scientists - September 26th, 2011 [September 26th, 2011]
- DNA : The Secret Of Life (PBS) - September 26th, 2011 [September 26th, 2011]
- DNA - Size - September 27th, 2011 [September 27th, 2011]
- Starchild Skull 2010 DNA Result - September 28th, 2011 [September 28th, 2011]
- Cowboy BeBop- Ask DNA - September 28th, 2011 [September 28th, 2011]
- Symphony of Science -- DNA and Life - September 30th, 2011 [September 30th, 2011]
- Molecular Biology Visualization of DNA - October 2nd, 2011 [October 2nd, 2011]
- Same Dna Livin Life Ep 8 - October 4th, 2011 [October 4th, 2011]
- Danny Brown - DNA - October 4th, 2011 [October 4th, 2011]
- Rockmond Dunbar Traces His DNA To Nigeria - October 5th, 2011 [October 5th, 2011]
- TEDxFortGreeneSalon - Melvin Gibbs - The DNA Project - October 5th, 2011 [October 5th, 2011]
- Building a tiny "DNA brain" (Part I: design) - October 5th, 2011 [October 5th, 2011]
- DNA "Post-Summer Madness 2011" Interview Part 1 [EME] - October 5th, 2011 [October 5th, 2011]
- Proof that Evolution is True/Real/Fact: Mutations, DNA, Natural Selection - October 9th, 2011 [October 9th, 2011]
- DA John Bradley once excluded DNA testing - October 9th, 2011 [October 9th, 2011]
- Benbassat Says Apple's `DNA' Will Continue After Jobs - October 10th, 2011 [October 10th, 2011]
- BRO BOBBY HEMMITT; DNA TRANSFORMATION part 1 - October 10th, 2011 [October 10th, 2011]
- DNA - 2 Ounces And A Dream (Instrumental) - October 10th, 2011 [October 10th, 2011]
- The Truth About Italian DNA - October 10th, 2011 [October 10th, 2011]
- DNA - Ludovico Einaudi - October 13th, 2011 [October 13th, 2011]
- DNA - FAIR FIGHT (THE SNITCH) PROD BY : BLESSED BY THE BEATS - Video - October 13th, 2011 [October 13th, 2011]
- DNA REPAIR - Video - October 13th, 2011 [October 13th, 2011]
- DNA MUTATION - Video - October 14th, 2011 [October 14th, 2011]
- Spiritual DNA - Video - October 14th, 2011 [October 14th, 2011]
- DNA Structure - Video - October 14th, 2011 [October 14th, 2011]
- DNA - Video - October 14th, 2011 [October 14th, 2011]
- DNA Replication - Video - October 14th, 2011 [October 14th, 2011]
- THE DNA SONG - Video - October 14th, 2011 [October 14th, 2011]
- That Spells DNA by Jonathan Coulton - Video - October 15th, 2011 [October 15th, 2011]
- DNA Activation Power - 2012 Ascension - Video - October 15th, 2011 [October 15th, 2011]
- Journey Inside The Cell - Video - October 15th, 2011 [October 15th, 2011]
- DNA - ROMAN NUMERALS (MUSIC VIDEO) - Video - October 15th, 2011 [October 15th, 2011]
- DNA - Blonde Red Head - Video - October 16th, 2011 [October 16th, 2011]
- [HD] The Kills - DNA (Live in Paris @ Bataclan, April 6th, 2011) - Video - October 17th, 2011 [October 17th, 2011]
- Blackfield - DNA - Video - October 22nd, 2011 [October 22nd, 2011]