A company that makes a blood test that detects dozens of types of cancer has acknowledged that about 400 of its customers were mistakenly told last month that they might have the disease.
The company, Grail, said in an emailed statement on Sunday that a vendor it works with has sent hundreds of letters with false test results because of a “software configuration issue” that has since been resolved.
The letters went to customers who recently bought Grail’s Galleri test, which uses a blood draw to detect a cancer signal shared by 50 types of cancer and is only available by prescription.
The problem was not caused by inaccurate test results, Grail said. More than half of the people who received the error letter never had their blood drawn for the test, the company said.
The vendor, PWNHealth, notified Grail on May 19 that an “inaccurate form letter” was sent to approximately 400 customers from May 10 to May 18, Grail said in its statement. Inaccurate messages are The Financial Times reported.
After Grail was notified of the problem, it contacted affected customers by phone and email, the company said. “No patient health information has been disclosed or compromised as a result of this issue, and no patient harm or adverse event has been reported,” it said.
PWNHealth said in an emailed statement that, after it became aware of the problem, it learned that a system used to send template messages to people had a “misconfiguration.” The company did not specify how it learned about the issue.
“We addressed the underlying problem within an hour of becoming aware of it and implemented additional processes to ensure it doesn’t happen again,” the company said. “Working with Grail, we began contacting affected individuals within 36 hours.”
The test result letters were falsely sent amid a regulatory battle between the United States and Grail’s parent company, Illumina, the leading maker of gene-sequencing machines. Illumina acquired Grail in August 2021.
In April, the Federal Trade Commission ordered Illumina to divest itself of Grail because the acquisition could “stifle competition and innovation” in cancer testing, raise prices and shrink choices for consumers.
Illumina said it will appeal the FTC’s ruling and a similar challenge to the European Union’s regulation. The company said in April that winning both appeals would allow it to make the Galleri test more widely available, as well as more affordable and profitable.
If its appeals fail, Illumina will “move swiftly to remove” itself from Grail, the company said.
