Hundreds were wrongly told they may have cancer, the testing company says

A company that has developed a blood test that detects dozens of cancers has acknowledged that about 400 of its customers were wrongly told last month they could have the disease.

The company, Grail, said in an emailed statement Sunday that a supplier it works with had sent hundreds of letters with incorrect test results because of a “software configuration issue” that has since been resolved.

The letters went to customers who recently purchased the Grail’s Galleri test, which uses a blood draw to detect a cancer signal shared by 50 types of cancer and is available by prescription only.

The problem was not caused by inaccurate test results, Grail said. More than half of the people who received the letter in error had not yet had their blood drawn for the test, the company said.

The supplier, PWNHealth, informed Grail on May 19 that an “inaccurate form letter” had been sent to about 400 customers between May 10 and May 18, Grail said in its statement. The inaccurate messages were reports The Financial Times.

After Grail was made aware of the issue, it contacted affected customers by phone and email, the company said. “No patient health information has been disclosed or violated because of this issue, and no patient harm or adverse events have been reported,” the report said.

PWNHealth said in an emailed statement that after learning about the issue, it found that a system used to send template messages to people had a “misconfiguration.” The company did not specify how it learned of the problem.

“We addressed the underlying issue within an hour of becoming aware of it and have 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 letters containing the test results were sent in error during 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 from Grail, saying the acquisition “could stifle competition and innovation” in cancer testing, raise prices and narrow consumer choice.

Illumina said it would appeal the FTC ruling and a similar regulatory challenge by the European Union. The company said in April that winning both appeals would allow the Galleri test to be more widely available, affordable and profitable.

If the appeal fails, Illumina will “act with urgency to divest Grail,” the company said.