Sorting Out the Confusion: Grail’s Incorrect Cancer Test Results

Last month, over 400 patients who took an innovative cancer detection test created by Grail, a US biotech company, were mistakenly informed that they might have developed cancer through letters.

The mistake was caused by an error in the algorithm used to analyze the test results, which led to false positives. Grail has since apologized for the mistake and is taking steps to ensure it does not happen again. The incident highlights the need for rigorous testing and validation of new medical technologies before making them available to patients.

The internal company document obtained by The Financial Times also showed that the mistake was due to a technical error in the laboratory’s software system. The company has since apologized to the affected patients and promised to take necessary measures to prevent similar mistakes. The incident highlights the importance of quality control measures to minimize errors and ensure patient safety in the healthcare industry.

According to Grail, their telemedicine provider PWNHealth sent letters by mistake. However, Grail’s team promptly contacted the impacted customers to inform them that their test results were inaccurate and to alleviate any concerns they may have had.

The Financial Times was able to view an internal company document that revealed 408 patients were mistakenly informed that there was a sign of cancer in their blood.

Grail's Incorrect Cancer Test Results

Grail’s swift response shows its dedication to providing high-quality service and ensuring the accuracy of its test results. Despite the mistake made by their telemedicine provider, they took responsibility and took steps to rectify the situation. This level of transparency and accountability is commendable and should be a standard in the healthcare industry.

Some insurers who are testing Galleri, a multi-cancer early-detection test that claims to detect over 50 cancers from a single blood sample, are worried about the recent incident.

Some insurers who are testing Galleri, a multi-cancer early-detection test that claims to detect over 50 cancers from a single blood sample, are worried about the recent incident.

They are concerned about the accuracy of the test and the potential financial impact it could have if false positives or negatives occur. The insurers want to ensure that their policyholders receive the most reliable and practical testing to detect cancer early.

A pilot program at MassMutual, a prominent US life insurance company, has been temporarily suspended after a few of their policyholders were affected.

The pilot program, which aimed to incentivize policyholders to live a healthy lifestyle by tracking their activity levels through wearable devices, was met with mixed reactions from customers. While some appreciated the potential benefits, others expressed concerns over privacy and data security.

The program’s temporary suspension allows MassMutual to address these concerns and make necessary adjustments before potentially reintroducing it.

We have been made aware that Grail has taken action to resolve the issue with our participants. Furthermore, Principal, a significant life insurance company in the US with impacted clients, is evaluating their association with Grail following this occurrence.

This episode highlights the potential risks that insurers face when implementing early-detection technologies. While these technologies can help prevent customers from getting sick and reduce the amount paid out in claims, there are also potential downsides to consider.

Grail, a subsidiary of the largest gene sequencing company in the world, Illumina, is offering the Galleri test at approximately $950 per test. This test is designed to scan cell-free DNA for changes that may indicate the presence of cancer cells and is being marketed to insurers and large employers.

The British and US health chiefs have praised the recent test as “revolutionary” and “cutting edge.” However, experts have advised us to proceed cautiously and conduct large-scale clinical trials before implementing them to ensure their effectiveness in saving lives.

In a statement, Grail clarified that an incorrect Galleri laboratory test result did not cause the wrong letters to be sent to patients. The notes were triggered by an unintended issue in the PWNHealth software configuration, which has since been disabled.

PWNHealth immediately investigated and solved the issue within an hour of discovering it. They have also put measures in place to prevent it from happening in the future.

“We teamed up with Grail and reached out to affected individuals within 36 hours,” the statement said.

This weekend, Grail will present on Galleri at a major cancer conference in the US. However, they have reported that more than 50% of the recipients who sent letters have yet to undergo the Galleri blood test.

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

John Hancock, a US life insurance company, has announced plans to provide broader access to Grail’s unique testing services. The company believes that early detection and preventive care are crucial in helping customers live longer and healthier lives. John Hancock has partnered with Munich Re for a pilot program that was announced in September.

John Hancock’s spokesperson confirmed their partnership with Grail remains the same, while Munich Re declined to comment.

EverlyWell, a digital health company, owns PWNHealth, an independent telemedicine vendor that handles Galleri test requests. PWNHealth prescribes the test and delivers the results to patients.