On 6 March 2018, the FDA approved the marketing of a test for breast cancer risk for three BRCA1 and BRCA2 gene variants, developed by the California-based company23andme. Unlike other genetic tests currently on the market, these kits will be available without a prescription – a fact that Jean-Yves Nau finds “worrying”. Indeed, a simple saliva test would inform women whether or not they carry genetic variants associated with a higher risk of developing cancer.
This decision “marks a turning point in the FDA’s stance following its instruction that 23andMe should withdraw from the market in 2013. (…) The Agency highlighted the risk to patients in the event of error or misinterpretation of test results”. Today, the FDA deems that “the data provided by 23andMe are adequate to guarantee the reliability of the tests which should be carried out at the ‘consumer’s’ discretion”. On this note, the FDA announced in 2017 that a genetic risk does not mean that patients “will or won’t develop a disease” arguing that “the results obtained should not be used to confirm diagnosis or determine treatment”.
23andme is consolidating its position. With its 2 million profiles, the company has “one of the largest genetic databases in the world” – “a genuine gold mine for pharmaceutical laboratories”. The market for these tests “should soar from $110 million in 2017 to 340 million in 2022” providing information of widespread interest for insurance companies and pharmaceutical marketing departments to name but a few, “who, based on this data, can target you to sell you such and such a product, or possibly refuse such and such insurance cover,” as explained as early as 2015 by Bertrand Jordan in the Médecine/Sciences journal. He went on to add that, “We also know that an ‘anonymous’ DNA sequence can be easily linked to a specific person. Our ‘genetic intimacy’ is in danger (…). This is a general problem but it is especially acute in terms of human health and genome. In actual fact, we are potentially reaching a point where private life as we know it or at least a specific concept of intimacy could come to an end”.
In France, “genetic tests for cancer risks are available only on medical prescription” and are therefore “strictly defined”.