Last month, more than 400 patients who applied to take a pioneering tumor-detection test developed by US biotech company Grail received a false letter suggesting they may have developed cancer.
According to an internal document obtained by the Financial Times, 408 patients were falsely told they had signals in their blood that suggested they might have cancer.
Grail said the letter was sent “by mistake” by the company’s telemedicine provider, PWNHealth, and staff responded quickly to reach out to affected customers and reassure them that the test results were incorrect. said he let
The incident has raised concerns among some insurers testing a multi-cancer early detection test, Galleri, which claims to be able to detect more than 50 cancers with a single blood draw.
MassMutual, one of the largest U.S. life insurers, said a “small number” of policyholders had been affected and had “suspended” its trials as a result.
“We are aware that Grail has proactively reached out to all participants to address this issue as soon as possible,” the company said.
Another major US life insurance company principal with customers affected by the error said it was reviewing its relationship with Grail following the incident.
This episode highlights the risks in insurers deploying early detection technology that offers the potential to reduce insurance payouts by keeping customers healthy.
Grail, a subsidiary of Illumina, the world’s largest genetic sequencing company, sells Galeri for about $950 per test and pitches it to insurance companies and large employers. This test scans so-called cell-free DNA to look for changes caused by cancer cells.
The test has been hailed as “revolutionary” and “state-of-the-art” by health officials in the United Kingdom and the United States, but many experts warned it would not be introduced before large-scale clinical trials proved it could save lives. I am asking for caution.
Grail said the erroneous lettering was in no way related to or caused by the erroneous results of the Garelli Institute’s test results. The company said in a statement that the letter was accidentally triggered by a PWNHealth software configuration issue and is now disabled.
PWNHealth said it immediately launched an investigation, addressed the underlying issue within an hour of becoming aware of the issue, and put processes in place to prevent a recurrence.
“We have partnered with Grail to begin contacting affected individuals within 36 hours,” it added.
Grail plans to present on Garelli this weekend at the nation’s largest cancer conference, but said more than half of those who received the letter had not yet had their blood drawn for the Garelli test.
The company said there was “no disclosure or compromise of patient health information due to this issue, and no patient harm or adverse events have been reported.”
U.S. life insurer John Hancock announced in February that it would expand access to Grail’s “unprecedented” test to help its customers “live longer, healthier and better.” He said preventive care and early detection are essential to the company’s efforts. We worked with Munich Re on a pilot that was announced in September.
A spokesperson for John Hancock said the partnership with Grail remains unchanged. Munich Re declined to comment.
A subsidiary of digital health company Everlywell, PWNHealth is an independent telemedicine vendor that reviews Galleri’s test requests, prescribes tests, and delivers results to patients.