Hundreds of people who used Grail’s Galleri multicancer blood test reportedly received letters last month incorrectly indicating that they might have cancer.
The Galleri liquid biopsy is designed to detect a signal in the blood linked to more than 50 types of cancer—all from a single standard blood draw. According to Grail, the test boasts a specificity of 99.5%. The prescription-only Galleri test is ordered for individuals by their healthcare providers, and its $949 list price isn’t currently covered by insurance.
The Financial Times was first to report the erroneous letters, citing an internal company document showing that 408 Galleri test takers had been mistakenly told they had the cancer-related signal.
Grail confirmed the error, saying in a statement sent to Fierce Medtech that “the issue was in no way related to or caused by an incorrect Galleri laboratory test result.” Instead, per the company, its go-to telemedicine provider, PWNHealth, had accidentally sent out the letters due to a software issue.
The software configuration flaw behind the false form letters has since been disabled, according to the statement. Grail added that more than half of the letters were sent before recipients had even had their blood drawn for the Galleri test.
The incorrect letters were sent out between May 10 and May 18, and PWNHealth notified Grail about the issue May 19.
“After being notified of the incident, Grail immediately began outreach by phone or email to all individuals who received the PWNHealth letter, and we continued our efforts until we confirmed we successfully reached each individual via phone, email or letter,” the testmaker said.
Grail noted that none of the patients’ information was improperly breached or disclosed due to the issue, nor have any adverse events or other instances of patient harm been reported in conjunction with the false letters.
“As a patient-focused company, Grail takes seriously our commitment to ensure reliable and accurate Galleri test results and the highest quality experience for our patients,” it added in the statement. “To that end, Grail has numerous quality control processes to ensure that Galleri test results meet our rigorous reliability and accuracy requirements.”
Meanwhile, separately from this issue, Grail is in the midst of another snafu. After its original parent company Illumina moved to re-acquire Grail for $8 billion in 2021, despite ongoing antitrust investigations in both the U.S. and EU, regulators on both continents have since cracked down.
Last fall, the European Commission officially moved to block the acquisition. And in April of this year, just a few months after ceding a small win to Illumina along the way, the U.S. Federal Trade Commission followed suit, ordering Illumina to completely divest Grail. Illumina is now in the process of appealing the decision; it filed the official appeal with the FTC on Monday.