According to reports, hundreds of patients who utilized Grail's Galleri multicancer blood test last month received letters erroneously suggesting they could have cancer.
With only one typical blood sample, the Galleri liquid biopsy may identify a blood signal associated with more than 50 different cancer types. The test, according to Grail, has a 99.5% specificity. Grail, an American biotechnology company, was founded in 2015 in San Francisco, California, to help detect cancer in its early stages.
The $949 advertised price of the prescription-only Galleri test, which patients' medical professionals prescribe, is not currently covered by insurance. The Financial Times was the first to publish the erroneous letters, citing an internal business document that showed 408 Galleri test participants had been misinformed they had the cancer-related signal.
In a statement provided to Fierce Medtech, Grail acknowledged the error and stated that "the issue was in no way related to or caused by an incorrect Galleri laboratory test result."
Instead, according to the business, its preferred telemedicine provider, PWNHealth, unintentionally sent the letters due to a software flaw.
The inaccurate letters were distributed between May 10 and May 18, and on May 19, PWNHealth alerted Grail of the problem.
"We addressed the underlying problem within an hour of becoming aware of it and have implemented additional processes to ensure it does not happen again," says PWNHealth. "In partnership with Grail, we started contacting impacted individuals within 36 hours."
The statement claims that the invalid form letters' underlying software configuration fault has been deactivated. Grail stated that more than half of the letters were delivered before the Galleri test recipients had collected their blood.
"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," says the test maker.
According to Grail, no patient information was unlawfully compromised or leaked due to the problem, and no adverse events or other patient damage have been recorded in connection with the fraudulent 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," continues the statement.
"To that end, Grail has numerous quality control processes to ensure that Galleri test results meet our rigorous reliability and accuracy requirements."