Deadline for Personal Genomics Companies

State of New York has issues warning against Personal genomics companies , after they have received many complaints. Now the State of California Department of Helath (CDPH) is trying to keep consumer genetic testing companies from offering their services to the state’s residents and last week sent letters to 13 firms saying they are violating state law. The companies have time till today June 24 to respond to the notice. While New York State warned several companies that genome tests could not be performed on samples from New York residents without formal state approval.

CDPH requirements mandate that

  1. Any business offering genetic tests to California residents must be licensed as a clinical laboratory in California
  2. The laboratory must have must have a CLIA certificate for laboratory testing
  3. All genetic tests must be ordered by a licensed physician

The 3rd part of the requirements mean the end of DIY genetic testing and more headches for companies in coming weeks.

Google-backed 23andMe and Navigenics are also included in the list of companies that received the notice The major companies, including 23andMe, Navigenics, and Decode Genetics have issued statements confirming that theya re using CLIA registered laboraotries for the testing DNA genotyping. 23andMe partners with Illumina, while Navigenics collaborates with Affymetrix.

Steven Murphy compared these companies to napster check out his blog post1 post2 on this subjetcs. He is certainly not likely to be excited to learn that 23andMe has launched a wiki page called 23andWe to recruit its customers to participate in studies trying to shed additional light on genetic predispositions for certain diseases and adverse drug reactions.

23andMe has maintained that it is not selling a medical service but rather giving people access to their genetic information. They company prefers to call its 23andWe study participants “customers” and not “patients,” . Smart move but lets see if CDPH is going to buy that argument.

But today 23andMe shot back to CDPH that they’ll be doing neither cease nor desist. We believe we are in compliance with California law and are continuing to operate in California at this time,” the company said in a statement released to Wired.com

The company has has argued that the testing they provide isn’t a prevention aid, but merely offers “individuals contextual information about their genetic makeup, including ancestry and applicable scientific research.”

UK Government-backed sociology study using Genetics raises privacy concerns

The Uk government backed UK Household Longitudinal Study to use genetics analysis of British citizens (previous post on UK BioBank) to assess impact of Genetics and lifestyle in health and medical treatment and how it affects people’s social and economic status over time, is turning into controversy. The expansion of the program to cover “nature versus nurture” questions through genetic and medical testing has raised fears among civil liberties campaigners.

More than 100,000 people, including children as young as 10, will be asked to provide saliva tests and DNA samples in a new annual survey of the lives, behaviour and beliefs of people in the United Kingdom.

I thought of how we are going to look at privacy concerns at such government backed studies, Take a look at the blog by Deepak Singh Your personal health: The internet and privacy

Even though participation is voluntary The plan has been denounced by civil rights campaigners. ‘I would not let my DNA details be taken in this way,’ said Richard Clayton, the barrister representing the rights group Liberty in its fight to prevent police from keeping DNA samples of suspects later cleared of wrongdoing as quoted on The Observer

Details of the study is available at the University Essex website of UK Household Longitudinal Study

DNA test results in three days, or Money Back

IDENTIGENE Becomes First DNA Testing Lab to Promise Fast Results with a Money-Back Guarantee . The company now Now Offers the Industry’s First Money-Back Guarantee, together with a Three-Day Turnaround on Results

the website says IDENTIGENE is the only DNA testing lab with a money-back guarantee

 

 

 

 

 

Microarray to detect mutations in largest Human Gene

The average human gene consists of 3000 bases, but sizes vary greatly, with the largest known human gene being dystrophin at 2.4 million bases. Residing at Chromosome 4 it has long been of interest to the medical community because its the gene responsible for huntington’s disease, polycystic kidney disease, a form of muscular dystrophy and a variety of other inherited disorders. Chromosome 2 is noteworthy for being the second largest human chromosome, trailing only chromosome 1 in size. It is also home to the gene with the longest known, protein-coding sequence – a 280,000 base pair gene that codes for a muscle protein, called titin, which is 33,000 amino acids long.

Now reseacrhers at Emory university has developed a microarray based test to chek for mutations in this gene. The current test do not detect all types of mutation that affects 1 in 3500 males according to the university wesbite.

Mutations in the dystrophin such as point mutations in a sequence of DNA can result in mistakes in gene  expression and nonfunctional proteins that causes Duchenne muscular dystrophy (DMD).

A detailed presentation of the advantages of the test is available at the Emory Genetics Testing website. The test offeredon the Nimblegen CGH array platform gains more prominance as the company is now being acquired by Roche who has plans to dominate the clinical microarray market with its products in genetics testing space

The emory university Genetics testing lab offers numerous other genetic tests

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