COMPANY:

GRAIL

"GRAIL, Inc...and Quest Diagnostics (NYSE: DGX)...today announced the initial phase of a program to improve provider access to GRAIL's Galleri® multi-cancer early detection (MCED) test. Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest's Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year."

P=NA | N=6,662 | PATHFINDER (NCT04241796) | Sponsor: GRAIL, Inc. | "PRO assessment was conducted for eligible PATHFINDER study participants with either a cancer signal detected (CSD) or no cancer signal detected (NCSD) over a 12-month follow-up period....Overall the study demonstrated minimal patient distress associated with MCED testing. Most participants with a NCSD result responded that they were 'relieved about my test result'. The negative patient-reported impacts associated with a CSD test result were small and returned to baseline within 12 months. High overall satisfaction with the MCED test was reported across participant groups regardless of signal detection status and eventual diagnosis. Most participants reported they were 'likely'/'very likely' to adhere to future guideline recommended screening tests as recommended by their healthcare provider."

"GRAIL, Inc...today announced that it has granted equity awards in the form of restricted stock units (“RSUs”) underlying an aggregate of 115,093 shares of GRAIL’s common stock to 46 recently hired non-executive employees as an inducement material to their acceptance of employment with GRAIL. The employment inducement awards were granted under GRAIL’s Inducement Equity Incentive Plan and related form of restricted stock award agreement in accordance with Nasdaq Listing Rule 5635(c)(4)."

"GRAIL, Inc...announced early results from the REFLECTION study, which aims to understand the real-world experience of the Galleri® multi-cancer early detection (MCED) test in routine clinical settings. The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. In this study, a diverse population of veterans from U.S. Department of Veterans Affairs (VA) sites with toxic exposure but with no symptoms suggestive of cancer were included in study enrollment. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate consistent with other populations that have received the MCED test. The findings were presented during a presentation at the 2024 Early Detection of Cancer Conference (EDCC)."

P=NA | N=NA | "GRAIL, Inc...announced that detailed findings of the performance of its Galleri multi-cancer early detection (MCED) test in prostate cancer were published in JCO Precision Oncology....Results from this analysis showed that of the prostate cancers that were detected by the MCED test, most were clinically significant (93% were intermediate or high grade and 67% were stage III or IV). For detected prostate cancers, the cancer signal of origin (CSO) prediction accuracy was > 90%. Detectability for stage I and II cancers were 4.2% across both studies combined, which is expected with low shedding prostate cancer tumor fraction and is consistent with cfDNA literature in prostate cancer. Test sensitivity of prostate cancer for all stages was 11.2% in substudy CCGA-3."

"GRAIL, Inc...today announced that the first participant has been enrolled in the REACH/Galleri-Medicare study at Community Health Network, a leading integrated healthcare system in central Indiana with more than 200 sites of care....The Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH/Galleri-Medicare) study is a first-of-its-kind real-world evidence study designed to further evaluate the clinical impact of the Galleri multi-cancer early detection (MCED) test in Medicare beneficiaries."

"GRAIL, Inc...today provided an update on the PATHFINDER 2 and NHS-Galleri registrational clinical trials evaluating the Galleri multi-cancer early detection (MCED) test. GRAIL has completed the PATHFINDER 2 study's planned enrollment of more than 35,000 participants who are eligible for guideline-recommended cancer screening at more than 30 healthcare institutions in North America. In addition, GRAIL has completed the third and final round of study visits for the NHS-Galleri trial, which enrolled more than 140,000 participants....'We look forward to seeing results from the first 25,000 individuals enrolled in the PATHFINDER 2 study in the second half of 2025 and final results from the NHS-Galleri trial in 2026.'"

"Illumina, Inc. (NASDAQ: ILMN) today announced the successful completion of the spin-off of GRAIL. This milestone follows the company's previously announced plans to divest GRAIL, and GRAIL is now a public and independent company."