Tensions were high today at the US Congress Committee on Energy and Commerce hearing into direct-to-consumer (DTC) genetic testing.
Three spokespersons from the 3 major DTC testing companies (Navigenics, 23AndMe and Pathways Genomics) were made to defend their companies and the DTC industry whilst some of the committee members found it difficult to pick out the genuine companies from the scammers.
However, it doesn’t stop there. A new report of an undercover mission by the US Government Accountability Office (GAO) which covers the results of anonymous purchases of DTC kits from four companies and also an assessment of the deceptive marketing of 11 other companies.
The scepticism from GAO was based on the reporting, marketing and the scientific foundation in which the companies operate which added to the already climbing apprehension triggered by FDA meetings on lab-developed tests and also the recent warning letters received by another 14 genetic testing providers.
But that’s not even everything, there was also secretly taped recording included in the report covering conversations between GAO and some DTC companies.
In the tapes, the company Navigenics can be heard giving breast cancer advice whilst Pathway Genomics can be heard advocating the use of non-consensual DNA testing.
The other companies on the tape are presumed to be of the other anonymous companies and not part of the four creditable companies.
The tape really does not shed DTC in a good light, as badly-trained call operators from genuine companies can be heard unknowingly throwing the entire DTC industry under the bus.
Other clips in the tape cover a scam operation, which are not the products offered by the likes of 23AndMe and deCODEme.
The report reveals that individuals and consumers of DTC from certain companies were given advice information based on probability and not scientific diagnosis.
There was also a clear problem in consistency, where the same individual was given completely different risk predictions from various companies, which has been a common cynicism raised since the industry began, which now calls for an improvement on inclusion and background risk figures for the entire industry.
The report also declares that the ‘fake customers’ of GAO who were of non-European ancestry were not informed prior to purchasing that their risk predictions would be unreliable due to the lack of current genetic research outside of US and European populations.
The report appears to be unfairly one-sided, comparing the hard work of reliable companies who offer valid products with scammers trying to be a quick buck.
It tarnishes the entire industry with the same untrustworthy brush and overlooks technical accuracy of the companies products and service and doesn’t take into account the high number of more than satisfied customers.
We feel strongly that these reports are exaggerated on to lower public confidence in the industry and have scepticism published in news agencies across the globe.
The impact of this report is already apparent and visible in the industry, with several DTC companies leaving the market and only having their products available for private programs and some companies getting rid of some of their services such as disease risk predictions.
There seems to be general support of increased regulation today (especially by the committee) which after the reporting of findings today, will leave no room mistakes for the industry and clamp down on innovation.
I feel like this is a power-grab by the FDA, who will override small labs and startups who are seeking and researching new technologies for genetic testing.
Those in genomic medicine will simply pack up and move somewhere else in order to keep the industry alive if it becomes too difficult under new regulations in the US.