It was exactly ten years ago that we published a blog entitled “Blood tests to detect breast cancer early,” suggesting that if these tests were successful, they would be recognised as the Holy Grail in screening. A decade ago, the technology was still immature, but then in April 2020 we published an update, suggesting that a company called Grail could be on the cusp of a breakthrough product. While the company was optimistic that this was a seminal moment in the field of cancer diagnosis, their early detection of breast cancer still had some way to go.
For the past couple of years, Grail has been selling its Galleri blood test (seen below left, © Associated Press) – which reportedly detects over 50 different types of cancer – to customers via different vendors. Well, earlier this week, The New York Times reported that Grail had admitted “over 400 of its customers were mistakenly told last month that they might have the disease.” The company said that one of its vendors had sent out hundreds of letters with incorrect test results as a result of a “software configuration issue.”
Perhaps most astonishing of all, more than half of the customers who received the letter had not yet had their blood drawn for the test. Let’s think about that for a moment: You’re told you have been diagnosed with some form of cancer before you have even been tested! The vendor, Everly Health Solutions, contacted Grail on 19 May 2023 to explain that an “inaccurate form letter” had been generated and sent out to 400 customers. The company blamed the problem on a “misconfiguration” but did not explain how they discovered the issue.
To Grail’s credit, they contacted all the affected customers by telephone, as well as by e-mail, and have acknowledged: “No patient health information has been disclosed or breached due to this issue, and no patient harm or adverse events have been reported.” Interestingly, while this saga has been playing itself out, Grail’s parent company, Illumina, which is one of the leading manufacturers of gene-sequencing machines, has been engaged in a battle with the Federal Trade Commission (FTC).
The FTC has ordered Illumina “to divest itself of Grail because the acquisition could stifle competition and innovation in cancer testing,” arguing that this would raise prices and limit access for consumers. While Illumina has indicated it will appeal the FTC ruling, it firmly believes it is well placed to make testing more affordable. Sceptics might argue that Everly Health and Grail have shown they are nowhere near reaching the Holy Grail.