3andMe has moved to a subscription-based pricing

Direct-to-consumer genetics testing firm 23andMe has moved to a subscription-based pricing plan that now includes a one year contract and an additional charge of $5 per month.

Along with the change in pricing, the company has done away with its separate Ancestry Edition and Health Edition products, which are now part of one service, called Complete Edition, that the firm offers. The base price for the testing service remains at $499.

The Ancestry and Health Edition products were launched a year ago by 23andMe.

The changes took effect on Nov. 22. After the initial year expires, the contract will go to a month-to-month model, and customers will be able to cancel their contract at any time, a spokeswoman for Mountain View, Calif.-based 23andMe said.

In an e-mail, she said the new monthly charge is based on the company's need to update its test and customers' test results as new genetic discoveries are made. The company's scientific team continually evaluates the latest scientific studies on genetic associations and on average incorporates two to five new genetic discoveries into 23andMe's service each month.

In a separate announcement today, 23andMe said that it has transitioned to the third version of its genotyping array, enabling it to test approximately one million SNPs. Customers who purchase the 23andMe Personal Genome Service today or after will have their DNA tested on the new version of the array, it said. The new chip nearly doubles the number of SNPs for which the firm previously tested.

The unknown future rolls toward us 23andMe, The story continues

The tables turn, it's 23andMe's turn to send a letter to FDA... Continuing the story Reading Between Lines slapped with cease and desist letters.

Direct-to-consumer genomics firm 23andMe has sent a letter to the heads of the US Food and Drug Administration and National Institutes of Health asking for a collaborative effort to develop guidelines for genetic testing.

The firm posted the letter that it sent to FDA Commissioner Margaret Hamburg and NIH Director Francis Collins on its blog, The Spittoon, last night.

23andMe is one of several companies to be targeted recently by FDA, which sent letters to several firms saying that it believes the firms are selling unapproved diagnostic devices. The other firms that received letters were Knome, 23andMe, Decode Genetics, Navigenics, and Illumina, the last of which was cited for providing the tools that are used to provide genetic information to certain of the DTC genomics' customers.

In the letter sent to FDA and NIH, 23andMe noted that there have been reports of inconsistencies in the results provided by DTC genetic test providers. Specifically, it pointed to a paper published in October 2009 in the journal Nature, in which the authors cited inconsistencies in the results provided by 23andMe and Navigenics.

Though Nature did not publish a joint response from 23andMe and Navigenics to that paper, the firms made it publicly available. In that response, they took exception to some of the methods used, but they also said they agreed with most of the recommendations made by the authors, who were from the J. Craig Venter Institute and the Scripps Translational Science Institute.

"We believe that it is important to emphasize that different genetic testing companies can report inconsistent results even when based on tests with proven analytical validity," 23andMe wrote this week in its letter to FDA and NIH. It added that such inconsistent results may be confusing to physicians and consumers alike.

The firm asked FDA and NIH for help in developing broadly applicable standards and guidelines for providing genetic test results and risk estimates. For example, the firm said such a collaborative effort could develop guidelines for acceptable analytical validity; standards for the positive and negative predictive value of tests; and best practices for companies that could lead to results being readily compared across companies.

"We note that any framework developed for genetic testing companies must consider the multiple high throughput technologies on the horizon, including genome, exome and transcriptome sequencing," it said in the letter. "For this reason, the set of ideas we present above does not include having an organization define a specific set of markers as an acceptable genetic test."

23andMe-Led Team Offers Program to Enroll Parkinson's Patients

The personal genetics service firm 23andMe, the Michael J. Fox Foundation for Parkinson's Research, and the Parkinson's Institute and Clinical Center announced yesterday that they are enrolling 10,000 people to be part of a new Parkinson's disease community. The effort is aimed at establishing the resources necessary for future genome-wide association studies and other research initiatives.

In an effort to entice individuals with Parkinson's disease to participate, 23andMe is slashing the price of its service from $399 to $25 for a limited time for up to 10,000 individuals with Parkinson's disease who sign up through the Parkinson's Institute or the Michael J. Fox Foundation. Google co-founder Sergey Brin, who is married to 23andMe co-founder Ann Wojcicki, will ante up an undisclosed amount of cash to subsidize the genotyping costs.

To be eligible, individuals must have physician-diagnosed Parkinson's disease and agree to provide saliva samples and fill out online surveys about their condition. Members of the Parkinson's community will also have access to the complete 23andMe Personal Genome Service. Current 23andMe customers who do not have the disease can participate as healthy controls in the project by voluntarily filling out the company's Parkinson's disease survey.

The latest research project is distinct from a collaboration between the same organizations announced last spring, Rachel Cohen, manager of communications at 23andMe. Cohen said that effort was specifically aimed at developing web-based diagnostic tools for Parkinson's disease, whereas the latest project is aimed at making sure they have individuals with Parkinson's disease on board for research efforts.

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Just 400 bucks to sequence your own genome and make a personal genetic profile

Well it so exiting to watch how man makes his future ... The future, always so clear..., had become like a black highway at night. We were in uncharted territory now, making up history as we went along. The future is not set, because we control what happens through the choices we make. The GATTACA era is not far off.

23andMe has dramatically slashed the price for its service and expanded its offerings to include a lineage tracing service through a partnership with Ancestry.com. In a statement today said that by cutting the price for its genotyping service from $999 to $399 it is “democratizing personal genetics and expanding the opportunity for more people to benefit from the genetic revolution.”

The company said advances made to Illumina’s genotyping technology, specifically the introduction of the HumanHap550-Quad+ BeadChip, made the price cut possible. Illumina is the provider of genotyping tools for 23andMe’s services. 23andMe also said that beyond the new ancestry service it has added improved custom content to the BeadChip to include more SNP variations and rare mutations. “By taking advantage of continuing innovation we are able to introduce a new chip that will give people more relevant data at a lower price,” 23andMe Co-founder Anne Wojcicki said in a statement.

In addition to technological advances, there has been speculation from industry observers that the crop of new DTC genomics service providers, such as 23andMe, Navigenics, and DeCode Genetics, may be facing price pressure from an ongoing research initiative undertaken by the Coriell Institute for Medical Research earlier this year. Coriell is trying to recruit 100,000 volunteers — 10,000 by the end of 2009 — to provide DNA through a saliva sample for a similar, but free, service as those being offered by the commercial firms. The Camden, NJ-based institute plans to use the information in a research study exploring the utility of using genomic information in clinical decision making.

The company said the ancestry analysis service it will provide through the Ancestry.com partnership “allows users to trace their genetic lineage and discover the role that their ancestral origins have played in human history.” Ancestry.com’s DNA database contains over 7 billion names in 26,000 databases, and it includes more than 7 million user-submitted family trees, which enables customers to “trace their roots and connect with distant cousins,” 23andMe said.

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California Grants Navigenics, 23andMe Licenses to Offer Services in State

The last time i blogged on this issue Reading Between Lines and now California will allow two of the fourteen consumer genomics companies it slapped with cease and desist letters two months ago to again market their genotyping services in the state, the state’s Department of Public Health confirmed Thursday. The CDPH inspected both companies, and on Aug. 7 it granted a license to operate in the state to Navigenics and a week later it gave one to 23andMe. Both of these companies were among the group that CDPH in June said were operating outside of state regulations.

“State law requires these laboratories to have a license, obtain a physician's order from the consumer and demonstrate how they validate the results of their tests,”

“several” other of the companies that received the cease-and-desist notification have now applied for licenses in the state, but noted that the state is not currently disclosing further information about how it is investigating the other laboratories. Navigenics and 23andMe both are headquartered in California.

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