John Sterling Editor in Chief Genetic Engineering & Biotechnology News

While much of the attention in the biomedical community has been focused on clinical omics, i.e., the use of genomics research tools such as next-generation sequencing and biomarkers in hospital settings, a revolution has been rapidly taking place in the consumer genomics arena. The most recent entrant is Color Genomics which last week began business with $15 million in financing. The firm is marketing a physician-ordered kit to patients to test for genes linked to breast and ovarian cancers.  Color is “democratizing access to genetic testing” noted the company.

Two years ago the FDA prohibited 23andMe, originally a genetic ancestry company co-founded by CEO Anne Wojcicki, who is married to Google co-founder Sergey Brin, from providing DNA tests to customers so they could evaluate their health status. But two months ago, 23andMe was granted authorization by the agency to market the Bloom syndrome carrier status report. “This is the first-time the FDA has granted authorization to market a direct-to-consumer genetic test, and it gives us a regulatory framework for future submissions,” explained 23andMe officials.

The company also offers consumers who buy its test kit an invitation to participate in genomics research. Those who choose to do so could have their data used in a number of genetic studies involving 23andMe’s internal research team or with a company collaborator at a research university or pharmaceutical firm.

Ancestry.com, another company that jumped into the genetics field via genealogical studies, is also now asking its customers if they want to have their DNA researched and analyzed on a broader scale by its AncestryDNA service. The firm says it has over 800,000 genetic samples versus the 900,000+ samples banked by 23andMe. Through its analysis of genetic histories the company is discovering family-related health information which it plans to eventually offer to its customers for medical purposes a la 23andMe. But Ancestry.com is not there yet.

Meanwhile, the University of Michigan in January created an app, Genes for Good, directed at Facebook users. Participants supply health information and mail some saliva for genetic analysis. The service is free, research based, and also offers genealogical data. The Genes for Good team, whose goal is to engage about 20,000 participants, links genetic information to health information in order to find genes that affect risk for disease.

In the U.K. GeneU advertises itself as offering the “world’s first in-store DNA test for personalized skin care.” The company analyzes an individual’s DNA on a microchip and then provides serums and skin creams genetically matched to your DNA profile to counter the effects of aging.

Of course, there is a huge learning curve at play here. What may seem like simple plug-and-play products and services actually involves some complicated genetics issues. Simply having a specific gene in your genome does not always guarantee that you will get a specific disease or condition. Statistical probability, epigenetic factors, and environmental influences are also critical factors impacting genetic outcomes.

Most physicians have probably not had to deal with complex genetics since college so additional study will definitely be needed on their part. But the real elephant in the room is what sense consumers will make of their genetic profiles. In a number of countries, including the U.S., scientific illiteracy is widespread. Not only will many genetic product customers have no idea what to do with the information made available to them but in the absence of good medical advice or the presence of a genetic counsellor they may make bad decisions. They may also fall prey to charlatans looking to cash in on this evolving medical specialty.

Nevertheless, the world of genetics has now expanded beyond the lab and hospital clinic. Home genomics is well on its way and is here to stay.










































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