A company that developed a blood test that detects dozens of types of cancer has admitted that nearly 400 of its customers were wrongly told last month that they might have the disease.
The company, Grail, said in an emailed statement Sunday that a vendor it works with has sent hundreds of letters with incorrect test results due to “software configuration issues” that have been resolved.
The letters went to customers who had recently purchased Grail’s Gallery test, which uses a blood draw to detect cancer signals shared by 50 types of cancer and is available by prescription only.
The problem was not caused by incorrect test results, Greil said. More than half of the people who received the letter in error have not yet had their blood drawn for testing, the agency said.
The vendor, PWNHealth, notified Grail on May 19 that an “incorrect form letter” was sent to about 400 customers between May 10 and May 18, Grail said in its statement. There was a wrong message As reported by The Financial Times.
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 breached due to this issue, and no patient harm or adverse events have been reported,” it said.
PWNHealth said in an emailed statement that, after learning about the problem, it found that there was a “misconfiguration” of a system used to send template messages to people. The company did not specify how it came to know about the issue.
“We fixed the underlying issue within an hour of becoming aware of it and implemented additional processes to ensure it does not happen again,” the company said. “In partnership with Grail, we began contacting affected individuals within 36 hours.”
Letters of test results were sent in error amid a regulatory battle between the US and Grail’s parent company Illumina, a leading maker of gene-sequencing machines. Illumina acquired Grail in August 2021.
in aprilThe Federal Trade Commission ordered Illumina to divest itself from Grail because the acquisition could “stifle competition and innovation” in cancer testing, raise prices and narrow choices for consumers.
Illumina Dr It will appeal the FTC ruling and similar regulatory challenges from the European Union. The institution Dr Both appeals won in April will make gallery testing more widely available as well as more affordable and profitable.
If its appeal fails, Illumina will “move at a rapid pace” to divest itself from Grail, the company said.
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