spacer
home > ebr > summer 2017 > in your genes
PUBLICATIONS
European Biopharmaceutical Review

In Your Genes

In April 2017, the FDA formally approved the sale of direct-to-consumer genetic testing for 10 disease indications and established a framework for future approvals. This opens up the field to consumer genetic tests that are both accurate in their readout and significant in their interpretation. It places the US market on the same playing field as Canada and UK – but the move is not without controversy.

Advances in genomics have stimulated great interest as a tool for drug discovery, as a means of disease diagnosis and treatment and as an additional way to make sense of individual prognoses. Particularly in the consumer health arena, breathtaking advances in science have captured the public imagination as a possible way to predict future health outcomes. As a sidebar, the ancestry interpretation of personal genomics has become very popular.

The recent FDA move concludes four years of restrictions placed on claims and product offerings by the personal genomics company 23andMe. This was a time to validate the accuracy of the lab work, scientific significance and clinical relevance and to address concerns about the consumer-facing documentation and interpretation. Doctors had often been faced with difficult patient questions like, ‘how much does this increase my risk?’

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Emile Bellott is a member of the EBR Industry Advisory Board, and an industry consultant, with experience in drug discovery, development and pharmaceutical outsourcing.
spacer
Emile Bellott
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

£1 Billion Savings Opportunity and Value to the UK Economy from SBRI Healthcare Innovation Programme

An NHS England funded initiative to develop products that address unmet health needs, today released its annual report that shows how the programme has created a pipeline of innovations that could bring the NHS £1 billion of savings.
More info >>

White Papers
 
Industry Events

LogiMed 2017

18-19 October 2017, Hyperion Hotel, Hamburg

Taking place 18-19th October in Hamburg, LogiMed is Europe’s only dedicated medical device supply chain event bringing together over 150 Medical Device Supply Chain Professionals to network with. With a greater focus on customer collaboration and digital transformation this year’s LogiMed delivers real insights on inventory visibility, supply chain planning, global logistics and digitalization.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement