Boots is offering an over-the-counter paternity test kit, to the delight of some and the horror of others.
The chemist describes assuredna as "the first UK approved and regulated DNA paternity testing kit to be made available nationally via Boots". The test is "simple, safe and proven", processing and returning paternity results in one to five days.
Director of Comment on Reproductive Ethics Josephine Quintavalle led the criticism of the product. "Boots should not be involved in this type of genetic testing which has no real medical purpose," she told the Reg.
"It will be used almost exclusively as weaponry between battling adults in fraught relationships, to the detriment of the unfortunate child caught in the middle. This child will be unable to give informed consent to the use of his or her tissue but the emotional impact of the test results, which could include paternal rejection, are likely to be devastating."
The test was welcomed by Rob Williams, CEO of the Fatherhood Institute. "Knowing who your father is has enormous emotional consequences for a child," he said.
"If science can help to clarify parentage, then it would be perverse to argue that this is not a good thing as long as these tests are done with proper safeguards for the privacy of the parents.
"Consent of both adults is crucial to avoid abuse of this technology made possible by having it freely available over the counter. Where consent is not given, there are legal routes through which a possible father can request a paternity test."
The immediate justification, according to Boots, is the uncertainty on the part of some families about the paternity of their children. Every year in the UK the father’s name left blank on approximately 50,000 birth certificates.
Boots further claims that research estimates one in 25 assumed "fathers" in the UK are actually not the biological father.
The assuredna test kit claims to be easy to use, safe and reliable, with accuracy of results in excess of 99.99 per cent. It requires samples to be taken, by swab, from inside the mouth of father, child and mother. These are then sent off to UK-based testing service Anglia DNA for analysis.
The entire process, from start to finish, is likely to cost around £159: that’s £29.99 for the kit, and a further £129 lab fee for the standard five-day service.
The test is available to anyone aged 16 or over and requires signed consent and identification documents from father, child and mother – and from the mother on behalf of the child if the latter is under 16.
This aspect of the process is an absolute rquirement. DNA testing for paternity is governed by the Human Tissue Act 2004: testing without consent is a criminal offence, punishable by up to three years in prison; and companies carrying out tests must be licensed and regulated.
Nonetheless, both the Human Tissue Authority, which licenses organisations that store and use human tissue, and the Human Genetics Commission (HGC), a UK Government advisory body on new developments in human genetics, have expressed reservations in the past about services that involve samples being sent by post.
Pat Wilson, a spokesman for the HGC reportedly warned in 2009: "We have serious concerns about 'over the counter' genetic tests of this kind. DNA theft is a criminal offence and companies testing samples they have received through the post may not be able to establish if they have been freely given."
However, technical manager at Anglia DNA Dr Mandy Hartley was more confident of the positive side of the service offered. She said: “Every paternity issue is different, but for the majority of cases, families receive the results they were expecting.
“assuredna provides families with peace of mind so they can move on with their lives. Around half of all tests we conduct are related to children under 12 months, helping confirm paternity before the child has matured and is fully aware.” ®