Growing genetic self-testing market raises a variety of concerns

With the continuing rise of do-it-yourself consumer genetic testing kits, concerns grow as to data privacy, security and stewardship.

The market for direct-to-consumer genetic testing (DTC-GT) has boomed in the last half a decade or so, outlines KPMG Singapore partner and Life Sciences practice leader Ajay Sanganeria in a new report, with expectations it will grow to a worth of $1 billion by 2020. But this growth brings with it a range of complexities, among them concerns for the privacy and security of deeply personal data.

Thanks to the rapid advance in technology over recent years, what was once purely the domain of science and healthcare experts has now entered the everyday home, with the steadily increasing affordability, efficiency and simplicity of genetic testing opening up the market to self-sampling. In 2014, the DTC-GT sector was worth an estimated $300 million; within two years, it is forecast to top $1 billion.

According to KPMG, there are already more than 250 companies offering home-testing kits, focused on areas such as health, forensics, ancestry and paternity, pharmacogenomics (the effect of genes in response to drugs), and fitness and nutrition. Typically, consumers order the kits online, collect a DNA sample, and mail the sample to a laboratory for analysis – later receiving the results via the internet or post.

The sense of empowerment from the test results is cited by 80 percent of early adopters, serving as a key driver for market growth together with greater general awareness and public acceptance. Indeed, a KPMG survey from January 2016 found that at the time 60 percent of respondents were already willing to try a DTC-GT service, with 40 percent of those willing to buy one. Some popular tests have now fallen to as low as $65 plus shipping.

With the ten million mark of genotyped consumers surpassed this year (and predicted by the International Society of Genetic Genealogy to reach upwards of 100 million by 2021), some quick maths suggests that 8 million of the consumers to date have experienced a sense of greater empowerment through DTC-GT. But in submitting a sample, consumers risk losing the power to control highly sensitive personal information.

“Genomic data is special, since it encodes not only our blueprint, but that of our family and children,” says Caroline Rivett, Security and Privacy Life Sciences Lea for KPMG in the UK. “The continuing privacy and the security of people’s genetic data, both immediately, and into the long term, is of paramount importance.” Indeed, 65 percent of those willing to use a DTC-GT service report privacy as a top concern.

Market concerns

In addition to concerns for sharing personal data with third parties such as pharmaceutical companies, there are an array of implications concerning the future access to genetic data by external parties such as governments, insurers, employers and even prospective partners. There is the also the very real potential for data breach. Most popular test providers store samples for a minimum of 25 years – or otherwise indefinitely.

And there are further issues at play beyond individual privacy. The sharing of DNA inherently involves exposing sensitive personal information about one’s family members, who may not have provided consent. There are also suggestions it is possible to reverse the data de-identification process used by DTC-GT companies. And then there’s a range of questions as to the accuracy of the tests, the psychological impacts, and the potential consumer actions taken in response to the information.

“We look at three elements – where the data is stored and data security, how it moves for example on a blockchain, and how will it support clinical decision-making?” says Lance Little, Managing Director of multinational healthcare firm Roche’s Asia Pacific Diagnostics business. “With consumer genetic platforms, especially those where the data sets could be utilised, we see the need for appropriate governance and regulation.”

Little, however, adds; “Consumer genetic data could be very beneficial to health systems if used properly.” Yet, these emerging and unresolved questions make for an uncertain future regulatory landscape, potentially dampening future DTC-GT growth. Here, KPMG’s report recommends four key pillars to follow for market entrants; highlight consumer empowerment, provide actionable recommendations to complement test results, engage early with regulators on a country-by-country basis, and; address privacy concerns upfront and in clear language.