Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation

Read the full article: Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation:

"Ancestry.com, the popular genealogy site, is talking to the FDA about using DNA to estimate disease risk for the company’s member base. CEO Tim Sullivan revealed the news in an interview with The Verge, effectively announcing his company’s intention to eventually offer straight-to-consumer genetic testing.

Ancestry is currently in the "very early stages of a conversation with the FDA," Sullivan told The Verge. "We think it's totally appropriate that the FDA has stepped in to pretty aggressively regulate direct-to-consumer genetic tests—and we're just starting from that perspective, and trying to work very closely with them," he continued."

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FDA and SAEC Release First Data on Genetic Basis of ADEs

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Updated July 1, 2025

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FDA And International Serious Adverse Events Consortium Release First Data On Genetic Basis Of Adverse Drug Events - Pharmaceutical Online

---  the original post follows below  ---

The FDA just announced, FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events. The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions. “We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” said Arthur Holden, founder and chairman of the SAEC. This is a pretty exciting example of how to apply genomics to research the genetic basis of serious adverse events. 

Additional Information: 

• For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org. 
• For information on the FDA’s Critical Path Initiative see
  https://www.fda.gov/science-research/science-and-research-special-topics/critical-path-initiative

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FDA Final Guidance On Genetically Engineered Animals

The procedure of genetic engineering uses recombinant DNA for introducing new characteristics or traits into an animal. The new guidance, Guidance for Industry #187 - Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, provides all the needed details, so that the producers of these animals will know what to do in order to get the FDA's approval. Moreover, producers of these animals will also have to follow the law and regulations of the National Environmental Policy Act. I think these are truly remarkable times in the life of scientific discovery. Do you find these advances astounding or troubling? 

More Information & Related Posts: From the FDA: Genetically Engineered Animals Say Maaah - Goats Make Anti-Clot Drug 

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Say Maaah - Goats Make Anti-Clot Drug

This could be the shape of things to come, genetically engineered animals turned drug-making machines. This LA Times article, New old-fashioned drug makers: goats, reports that genetically engineered goats produce a human protein that is extracted and turned into a medicine to fight strokes, pulmonary embolisms and other dangerous conditions caused by blood clots. A panel of the Food and Drug Administration voted overwhelmingly that the drug -- called ATryn -- is safe and effective. The FDA is expected to make a final ruling soon. If approved, this would be unprecedented, the drug would be the first from a genetically engineered animal to be approved in the United States. If ATryn gets approved, you can expect to see more milk produced by genetically engineered rabbits and cows for future lines of drugs to treat hemophilia, respiratory disease and swollen tissues. By the way, do goats really say maaah?! 

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