More than 400 patients who signed as much as take a pioneering oncology detection check developed by US biotech firm Grail obtained inaccurate letters final month suggesting they may have developed cancer.
According to an inner firm doc seen by the Financial Times, 408 patients had been incorrectly told they had a sign of their blood suggesting they might have cancer.
Grail mentioned the letters had been despatched “in error” by its telemedicine supplier PWNHealth and that its employees had moved swiftly to contact affected prospects to reassure them their check outcomes had been improper.
The incident has generated concern amongst some insurers who’re trialing Galleri, a multi-cancer early detection check that claims to have the ability to spot extra than 50 cancers from a single draw of blood.
MassMutual, one of many largest US life assurers, mentioned a “small number” of its policyholders had been affected and that it had “paused” its pilot in consequence.
“We are aware that Grail proactively reached out to all our participants to address this issue as quickly as possible,” it mentioned.
Principal, one other large US life assurer that has prospects affected by the error, mentioned it was reviewing its relationship with Grail following the incident.
The episode underlines the dangers for insurers in adopting early-detection applied sciences, which supply the prospect of decreasing the quantity paid out in claims by preserving prospects more healthy.
Grail, which is a subsidiary of the world’s largest gene sequencing firm Illumina, is promoting Galleri at about $950 per check and advertising and marketing it to insurers and huge employers. The check scans so-called cell-free DNA for adjustments brought on by cancer cells.
The check has been hailed as “revolutionary” and “cutting edge” by British and US well being chiefs, though many specialists have urged warning in introducing them earlier than large-scale medical trials show they can save lives.
Grail mentioned the inaccurate letters had been on no account associated to or brought on by an incorrect Galleri laboratory check outcome. The letters had been inadvertently triggered by a PWNHealth software program configuration subject, which had now been disabled, it mentioned in an announcement.
PWNHealth mentioned it had promptly launched an investigation and addressed the underlying drawback inside an hour of turning into conscious of it and that it had applied processes to make sure it didn’t occur once more.
“In partnership with Grail, we started contacting impacted individuals within 36 hours,” it added.
Grail, which is because of make a presentation on Galleri this weekend on the largest cancer convention within the US, mentioned extra than half of people who obtained the letters had not but had their blood drawn for the Galleri check.
“No patient health information has been disclosed or breached due to this issue, and no patient harm or adverse events have been reported,” the corporate mentioned.
In February, US life insurance coverage firm John Hancock introduced it could increase entry to Grail’s “first-of-a-kind” check, saying preventive care and early detection was vital to its dedication to assist prospects stay “longer, healthier, better lives.” It collaborated with Munich Re on the pilot introduced in September.
A spokesperson for John Hancock mentioned its partnership with Grail had not modified. Munich Re declined to remark.
PWNHealth, which is a subsidiary of Everlywell, a digital well being firm, is an impartial telemedicine vendor which critiques Galleri check requests, prescribes the check and delivers outcomes to patients.
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