Hundreds of Patients Wrongly Diagnosed with Cancer Due to Software Mix-up

The biotech firm known as Grail made headlines earlier this year thanks to its signature Galleri blood tests, which can detect up to 50 different kinds of cancer early on to improve patient outcomes. The tests were hailed as the “first of its kind” when it hit the market in 2023. It is only available with a prescription and currently costs $949 per test.

But the company mistakenly notified some 400 customers that they tested positive for cancer.  The error was due to a “software configuration issue,” Grail said in a public statement. The problem was first detected by PWNHealth, a vendor of the software, which notified Grail on May 19. The incorrect diagnoses were handed out over the phone or by email, which came as a shock to many of the recipients.

“No patient health information has been disclosed or breached due to this issue, and no patient harm or adverse events have been reported,” the statement added. Grail blamed the issue on PWNHealth by saying it was caused by “a misconfiguration of our patient engagement platform used to send templated communications to individuals.”

Grail promised users that it has since revised the configuration process to make sure the mistake doesn’t happen again. The company quickly followed up with the patients by telling them that the results were false. According to the biotech firm, it’s not that the test results were inaccurate. It’s that they simply didn’t exist. Over half of the customers who were mistakenly notified had not even had their blood drawn for the test.

“We addressed the underlying problem within an hour of becoming aware of it and have implemented additional processes to ensure it does not happen again. The issue was in no way related to or caused by an incorrect Galleri laboratory test result.” PWNHealth said in a statement of its own. “In partnership with Grail, we started contacting impacted individuals within 36 hours.”

Companies like Grail are looking to cash in on rising demand for early cancer testing services. Grail bills its service as a complement to routine single-cancer tests that tend to be more accurate, such as mammograms and biopsies, while testing for cancers that aren’t usually included as part of the screening process, such as gallbladder cancer and pancreatic cancer. 

It’s important to note that none of these tests have been approved by the FDA. Instead, they are known as laboratory-developed tests, which allows CMS-approved labs to produce tests ordered by a doctor.

“People who order it now need to know that potentially you could find a cancer early, but it’s also possible that you might have an abnormal test where there’s not a cancer. It also will not find every cancer,” William Dahut, chief scientific officer for the American Cancer Society, told Bloomberg. “You have to know the limits of the information that’s available now.”