The website www.thebirthcompany.co.uk seen in April 2019, promoted a Non Invasive Prenatal Test for the detection of genetic conditions. On the Overview page, under the heading “HARMONY TEST”, text stated “99% T21 (Down’s Syndrome) (FPR < 0.1%). 97.4% T18 (Edwards Syndrome) (FPR < 0.1%). “>93.8% T13 Patau’s Syndrome) (FPR < 0.1%).” Text above stated “This is the combined test and has achieved a positive predictive value of about 84%. Women with a high risk have an option to proceed to chorion villous sampling (CVS) or amniocentesis.” Further text stated “the result of the simple blood test has a detection rate of more than 99% which will hugely reduce the need for invasive testing by CVS or amniocentesis. This is great news for couples because it eliminates the risk of miscarriage of the pregnancy” and “the result is expressed as a probability. It is a screening test and not a diagnostic test. A result form of a low risk test is shown below. A low risk test result gives a risk of a chromosomal problem of less than 1:10000. A high risk result gives a risk of greater than 99%. A high risk result does not confirm that the baby has the chromosome abnormality. An amniocentesis or chorionic villous sampling is necessary to give a diagnosis. The couple are counselled about this.” On the webpage for the Harmony test, text stated “The result of the simple blood test (Harmony), taken at 10 weeks or later has a sensitivity for the detection of Downs syndrome greater than 99%, 97.4% of Edwards syndrome and 93.8% of Patau’s syndrome, with a false positive rate of less than 0.1% which will hugely reduce the need for invasive testing by CVS or amniocentesis.”
The ASA challenged whether the ad misleadingly exaggerated the accuracy with which the treatment could detect whether a foetus would have the referenced genetic conditions.
The Birth Company said the data on their website related to the detection rate and the false positive rate of the Harmony Test. They explained the false positive rate was the number of pregnancies given a high probability result which did not have a foetus affected with the condition and the detection rate was the number of foetuses with the conditions that the test would identify. They said that the Harmony Test had a Positive Predictive Value of 80.9%, which represented the proportion of patients given a high probability result from an NIPT who go on to have the condition confirmed in the foetus. They explained that it was not included in the ad as it varied from patient to patient depending on whether they were low, risk, high risk or had any other risk factors such as previous affected pregnancies of ultrasound findings. In contrast, the detection rate applied to all pregnancies regardless of prior risk.
The ASA considered that consumers were likely to understand from the claims “a detection rate of more than 99%”, “a high risk result gives a risk of greater than 99%” and “detection of Down’s syndrome greater than 99%, 97.4% of Edwards syndrome and 93.8% of Patau’s syndrome” as the likelihood that a foetus would have the relevant condition if it had a NIPT “positive” result. We understood that the detection rate figure represented the proportion of foetuses that NIPT had identified to have the relevant condition out of all foetuses which ultimately had the condition. However, that figure did not give any insight into the proportion of positive results where the foetus would ultimately not have Down’s Syndrome. As such, while we understood that the detection rate was clinically useful for other reasons, we considered that its prominent use in the ad was likely to mislead consumers about how often the foetus would actually have the condition after receiving a “positive” NIPT result. We understood that a systematic review of the performance of NIPT in general found that it had a Positive Predictive Value (PPV) of 82% for Down’s Syndrome, 37% for Edwards’ Syndrome and 49% for Patau’s Syndrome, meaning out of all the foetuses with “positive” results, 82% would ultimately have Down’s Syndrome, as opposed to the 99% detection rate figure that consumers would understand from the ad. Likewise, 37% and 49% of foetuses would ultimately have Edwards’ Syndrome and Patau’s Syndrome respectively as opposed to 97.4% and 93.8% quoted in the ad. We understood that in any circumstance where a positive result was given, further invasive tests would be required in order to confirm that one way or the other. We considered that the detection rates in the ad were therefore likely to mislead consumers regarding the accuracy of a “positive” NIPT result. Because consumers were likely to understand from the ad that the detection rate signified the likelihood that the foetus would have the relevant condition in the event of a “positive result”, when that was not the case, we concluded that the ad was misleading. On that point, the ad breached CAP Code (Edition 12) rule 3.1, 3.3 (Misleading advertising), 3.9 and 3.10 (Qualification).
The ad must not appear again in its current form. We told The Birth Company to avoid using the detection rate figure or alternatively, if referencing the detection rate, to quote the Positive Predictive Value alongside an accompanying explanation of both figures.