15 February 2016
ByAppeared in BioNews 839
The Utah-based firm will use whole-genome sequencing to create individual reports on characteristics such as drug interactions and responses, fitness, nutrition and ancestry.
'Our company is dedicated to making personal DNA information accessible, while providing an engaging platform to help foster deeper understanding of what our DNA says about ourselves,' said Warren Little, CEO and co-founder of Sure Genomics.
'Just one test provides a lifetime of discoveries, helping us make more informed decisions about our personal health – and potentially our future generations.'
Aside from the $2500 test fee, there is also a $150 annual subscription fee, which customers must pay to receive twice-yearly re-analysis of their genetic data.
However, from a regulatory standpoint, there is much ambiguity regarding whether Sure Genomics should be providing information on BRCA1 and BRCA2 since the Food & Drug Administration (FDA) has not cleared direct-to-consumer tests for these mutations.
The FDA previously came down heavily on 23andMe for its direct-to-consumer genetic health tests (see BioNews 733), and Anne Wojcicki's company is still only allowed to provide limited information on disease risk to customers in the US (see BioNews 825). It appears as if, initially, Sure will only be providing disease-risk information on BRCA1 and BRCA2 and states it intends to 'release additional reports after they meet all required FDA regulatory standards'.
'We have been in contact with the FDA and we feel like we've built a system and process that would meet their requirements,' said Sure Genomics co-founder Rick White. '[Our] reports are going to be delivered in, I would say, an ultra-compliant manner,' he added.
The company also seems to be appeasing the FDA by having an in-house physician to prescribe the genetic testing. Those who make use of the service can also have a one-hour consultation with a genetic counsellor, although this is optional.
But Professor Mark Rothstein, from the University of Louisville, said he didn't believe the use of a prescribing doctor would influence the FDA. 'I don't think getting a doctor to order the test changes anything,' he told The Verge.
The FDA has previously expressed misgivings over direct-to-consumer genetic testing because of risks such as false-positives and -negatives, and concerns the results may lead patients to make decisions that adversely affect their health.