Grail provides final research results showing the accuracy of blood tests in finding 50 different cancers

The final results of the Grail study of cancer follow-up blood tests show that various tumors can be accurately detected at an early stage. In particular, tumors that are likely to be fatal and have few screening options.

Grail Started prescription Garelli diagnosis In the United States earlier this month. As a result of years of development and billions of dollars in venture capital funding, this test is designed to help discover as many as 50 different cancers and reveal the original organ site from a blood sample.

In a treatise published in a cancer journal Annual Tumor Report Using data collected from the company’s Circulating Cell-free Genome Atlas study, researchers found that the test could detect cancer before symptoms appeared, with an overall false positive rate of 0.5%. did.

However, when it comes to correctly identifying a tumor from a sample, the performance of the test depends on the type of cancer and the degree of progression. This test relies on capturing and analyzing small pieces of DNA released from the tumor into the bloodstream, and some cancers release more genetic material than other cancers.

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For example, tumors of the esophagus, liver, and pancreas (diseases with limited screening methods) were easier to detect by testing than breast, bowel, cervical, and prostate cancer, with a total sensitivity of 65.6%. However, it was 33.7% in the two groups. ,Respectively.

In addition, the sensitivity of the test increased with the malignancy of the cancer across all disease types. When tumors developed, they were up to 16.8% in early stage I, 40.4% in stage II, 77% in stage III, and 90.1% in stage IV. It metastasizes and spreads elsewhere in the body.

Grail’s Galleri test correctly identified the presence of cancer in 51.5% of more than 2,800 cases already diagnosed with the disease across all types of cancer and four stages.

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“Detecting cancer early, when treatment is likely to be successful, is one of the most important opportunities needed to reduce the burden of cancer,” said Glickman Urological, the lead author of the paper, at the Cleveland Clinic. Eric Klein, Chairman of the and Kidney Institute, said. ..

“These data suggest that multiple cancer detection tests, when used in combination with existing screening tests, can have significant implications for cancer detection methods and, ultimately, public health. “We do,” Klein said in a statement.

In addition, the test provided an 88.7% chance of identifying the organ site of the tumor, helping clinicians target the disease to be treated and select the most effective follow-up diagnosis.

The Galleri test does this by analyzing larger chemical structural changes in tumor DNA. Here, clusters of binding compounds known as methylation groups form specific patterns that can be traced back to individual cancer sites. Grail said he hopes the results will improve within 10 business days.

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Among those most likely to develop cancer, such as those between the ages of 50 and 79, researchers found that the overall positive predictive value of the test was 44.4% and the negative predictive value was 99.4%. discovered.

“Early detection of cancer is the next frontier in cancer research because it can save millions of lives worldwide,” said Fabrice André, editor-in-chief of Annals of Oncology, head of research at Institut Gustave Roussy in France. Says.

“Developing technology to address this issue is the first step. The next step involves the development of new therapeutic interventions,” Andre said. “At the same time, we need to continue with key demographic efforts, otherwise not all of these efforts will transform outcomes.”

According to DNA sequencing giant Illumina, it is expected that the Galleri test can be used to screen as many as 50 million people after its first launch and before Grail gets full FDA approval in 2023. We aim to spin out and buy it back in a $ 8 billion transaction that is currently under global antitrust scrutiny.

The US Federal Trade Commission Go to block tradingIllumina claims that owning its own cancer diagnostic test can curb the development of potential competitors. Illumina has a dominant market presence and is likely to rely on its hardware for research work.

The European Union’s competition watchdog has launched a similar investigation, Illumina sued Grail does not currently do business in Europe, so they block them by saying they lack jurisdiction.

Most recently, a federal court has granted that the FTC may postpone its legal action while waiting for results from across the pond. Meanwhile, the initial terms of the takeover offer are expected to expire in December of this year at the latest.