More than 400 Grail patients misdiagnosed they may have cancer

More than 400 patients who signed up to take a pioneering oncology detection test developed by US biotech company Grail received erroneous letters last month saying they might have cancer.

According to an internal company document seen by the Financial Times, 408 patients were wrongly told they had signs in their blood that they might have cancer.

Grill said the letters were sent “in error” by its telemedicine provider PWNHealth and that its staff moved swiftly to contact affected customers to assure them that their test results were incorrect.

The incident has raised concerns among some insurers who are testing Galleri, a multiple-cancer early detection test that claims to be able to detect more than 50 cancers from a single draw of blood.

MassMutual, one of the largest US life insurers, said a “small number” of its policyholders had been affected and had “paused” its pilot as a result.

“We know that Grail actively reached out to all of our participants to resolve this issue as quickly as possible,” it said.

Principal, another large US life assurer whose customers have been affected by the error, said it was reviewing its relationship with Grail following the incident.

The episode underscores the risks for insurers in adopting early-detection techniques that offer the potential to reduce the amount paid out in claims by keeping customers healthy.

Grail, a subsidiary of Illumina, the world’s largest gene sequencing company, is selling Gallery for about $950 per test and marketing it to insurers and large employers. The test scans so-called cell-free DNA for changes caused by cancer cells.

The test has been hailed as “revolutionary” and “state-of-the-art” by British and US health chiefs, although many experts have urged caution before large-scale clinical trials prove they can save lives. Are.

Grill stated that the erroneous letters were in no way related to or caused by the erroneous Gallerie lab test results. A statement said the letters were inadvertently triggered by a PWNHealth software configuration issue, which had now been disabled.

PWNHealth said it immediately launched an investigation and resolved the underlying problem within an hour of becoming aware of it, and implemented procedures to ensure it does not happen again.

“In partnership with Grail, we began contacting affected individuals within 36 hours,” it added.

Grill, who is due to give a presentation on Gallerie at the largest cancer conference in the US later this week, said that more than half of the individuals who received the letters had not yet had their blood taken for the Gallerie test.

“No patient health information has been disclosed or breached because of this issue, and no patient harms or adverse events have been reported,” the company said.

In February, American Life Assurer John Hancock announced that it would expand access to Grail’s “first of its kind” test, saying that preventive care and early detection would help customers live “longer, healthier, better lives”. was important to do. It collaborated with Munich Re on a pilot announced in September.

A spokeswoman for John Hancock said its partnership with the Grail has not changed. Munich Re declined to comment.

PWNHealth, a subsidiary of Everlywell, a digital health company, is an independent telemedicine vendor that reviews gallery test requests, schedules tests and provides results to patients.