The website, ultrasound-direct.com, seen in April 2019, promoted a Non Invasive Prenatal Test. Text stated “To test for Down's syndrome and certain other genetic conditions (T18 and 13 and Turners syndrome) from a maternal blood sample. The ultrasound scan will determine viability, if single or multiple foetus are present and accurately date your pregnancy. Includes: 30 minute diagnostic appointment.” The ad featured a table which stated that the NIPT + Scan had an “Accuracy in Detecting Down’s Syndrome” of “>99%” and a “False Positive Rate” of “0.1%.” Under the heading “What if my results indicate a baby with Down’s Syndrome?”, text stated “There are three possible results from NIPT for Down syndrome: Positive: Predicted to be affected by Down syndrome. An invasive test is required to confirm the result. Negative: Highly unlikely to be affected by Down syndrome. Inconclusive: Inconclusive results happen in up to 4% of cases. This is usually because the proportion of foetal DNA present in the sample is not high enough to give an accurate result. NIPT may be repeated with the hope that the cff DNA levels will have increased due to the increased gestation. NIPT detects around 98% of all babies with Down, Edwards and Patau syndromes.”
The ASA challenged whether:
1. the ad misleadingly exaggerated the accuracy with which the treatment could detect whether a foetus would have Down’s syndrome; and
2. the claim “diagnostic appointment” was misleading because they understood the treatment would not provide a diagnosis.
1. Ultrasound Direct said that their test detected over 99% of Down’s Syndrome cases, and provided a report which showed that they identified 107 out of 108 cases. The test had a false positive rate of 0.1% when applied to all test results i.e. over 99.9% of all results were correct. They said the Positive Predictive Value (PPV), which determined the likelihood that a high probability result was confirmed in the foetus, varied depending on each patient’s clinical history and the ultrasound indications, meaning that it was not something that could be reported for each patient. Ultrasound Direct offered to amend the claim “Accuracy in Detecting Down’s Syndrome. >99%” to “the detection rate is > 99%.” They said they would also include the positive predictive value of 81.6% for Down’s Syndrome in the ad.
2. Ultrasound Direct said all scans were required to be performed for diagnostic purposes in line with recommendations set out by the Society & College of Radiographers. They said the “Diagnostic Appointment” related to the scan element of the test that had being carried out coupled with NIPT. They said the term “diagnostic” was defined as “identifying a particular condition using a combination of resources”; they therefore believed the scan element of the appointment was diagnostic, given the checks that were performed on the foetus. They offered to amend the claim to “includes 30-minute appointment comprising a diagnostic scan and NIPT blood test.”
The ASA considered that consumers would interpret the claim “Accuracy in Detecting Down’s Syndrome. >99%” to mean that there was a 99% chance that a foetus would ultimately have Down’s Syndrome following a NIPT “positive result.” We understood that the detection rate figure represented the proportion of foetuses that NIPT had identified to have Down’s Syndrome 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 they had a Positive Predictive Value (PPV) of 82%, meaning out of all the foetuses with “positive” results, 82% would ultimately have Down’s Syndrome, as opposed to the 99% that consumers would understand from the ad. We understood that in any circumstance where a positive result was given, 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).
2. Upheld We considered consumers would interpret the claim “30 minute diagnostic appointment” to mean that the appointment would be able to identify with certainty whether the foetus had Down’s Syndrome among other conditions. As mentioned above, we understood that NIPT was not able to identify with certainty whether the foetus would have Down’s Syndrome with only 82% of the foetuses identified ultimately having Down’s Syndrome and that wherever a positive result was given a further invasive test would be required to confirm that either way. We therefore concluded that the claim “diagnostic” was misleading. On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising).
The ad must not appear again in its current form. We told Ultrasound 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. We also told them not to use the claim “diagnostic” to describe NIPT.