Preparing for FDA approval, Grail partners with health systems to validate its pan-cancer test

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There are many holy grails in the world of healthcare: solving interoperability issues, achieving health equity, and a universal patient record. Grail, the liquid biopsy company based in Menlo Park, Calif., is pursuing another equally difficult quest: to ensure that fewer people die of cancer.

Last June, the company introduced Galleri, a test that screens patients for more than 50 types of cancer. A year later, the company is partnering with health systems to build its database for the test and recruit 20,000 clinical study participants to gain Food and Drug Administration approval, Satnam said. Alag, senior vice president of software engineering and chief security officer at Grail. officer. He detailed these plans at AWS‘ Thursday virtual conference for innovation in health and life sciences.

Next Generation Sequencing Company Illumina spun Grail in 2016, and Grail deposit its IPO in 2020. The two companies were brought together last August when Illumina completed its acquisition of Grail. Through its various phases of ownership, the Silicon Valley-based company has always had one definitive mission: to develop a cancer detection test that works accurately and screens for all varieties of the disease.

of the Grail Galleries test analyzes blood samples to detect signals indicating the presence of cancer. If cancer is found, the test result can show clinicians where the cancer came from inside a patient’s body with 89% accuracy, Alag said.

In the company’s 2020 IPO filing, Grail said it would seek approval for the test as early as 2023. To prepare data for this review, the company is currently enrolling patients in a study to enroll 20 000 demographically diverse participants through North American healthcare systems. The trial is intended to help Grail refine its technology and expand its dataset, which focuses on the more than 30 million regions of the genome associated with carcinogenic epigenetic factors and methylation factors.

The test is intended for use in people at high risk for cancer, such as people aged 50 and over. Currently, patients can only access the test through Grail’s partner health systems, medical practices and self-insured employers. It costs $949 and requires a prescription.

Providence was the first health system partner of the Galleri test. The health system based in Renton, Washington integrated the trial in clinical care last year to help Grail assess the effectiveness of the tool and build its data set. Two weeks ago, based in New Orleans Health Ochsner announced that it will offer its patients the Galleri test in addition to recommended screenings for a single cancer.

The the most recommended screenings in the United States are for breast, lung, colon, prostate and cervical cancers. Alag said adding the Galleri test to these recommended screenings could potentially prevent 100,000 cancer-related deaths each year. If his remarks are true, the test could play an important role in reducing the 71% of cancer deaths caused by cancers without recommended screening.

“Instead of just screening individual cancers, we need to screen individuals for cancer,” he said.

Credit: Meletios Verras, Getty Images

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