A company that has developed blood tests to detect dozens of cancers admitted last month that about 400 of its customers were wrongly told they might have cancer.
In an emailed statement on Sunday, the company said its vendors had sent hundreds of letters with incorrect test results, citing “software configuration issues,” which have now been resolved. said there is.
The letter is addressed to customers who recently purchased Grail’s Galleri test, which detects cancer signals common to 50 types of cancer in a blood sample, and is available by prescription only.
Grail said the issue was not caused by inaccurate test results. More than half of the people who received the letter in error had not yet had their blood drawn for testing, the company said.
Vendor PWNHealth notified Grail on May 19 that “inaccurate form letters” were sent to approximately 400 customers between May 10 and May 18, Grail said in a statement. Incorrect messages are The Financial Times reported.
After being notified of the issue, Grail 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 events have been reported.”
In an emailed statement, PWNHealth said after learning of the issue, it discovered a “misconfiguration” in the system used to send template messages to people. The company did not say how it learned about the issue.
The company said it “addressed the underlying issue within an hour of becoming aware of it and put additional processes in place to prevent a recurrence.” “We have partnered with Grail to begin contacting affected individuals within 36 hours.”
The letter with the test results was sent in error amid a regulatory battle between the United States and Grail’s parent company, Illumina, a major manufacturer of gene sequencing machines. Illumina acquired Grail in August 2021.
The U.S. Federal Trade Commission issued a grail to Illumina in April, arguing that the acquisition could “hinder competition and innovation” in cancer testing, raise prices and limit consumer choice. ordered the sale of
Illumina said It plans to appeal the FTC ruling and similar regulatory challenges by the European Union. the company said In April, it announced that if it wins both appeals, it would make Garelli’s test more widely available, more affordable and profitable.
If the appeal is unsuccessful, Illumina will “move quickly toward the sale” of Grail, the company said.
