Tejas Savant

Douglas Schenkel

Kyle Mikson

Subbu Nambi

Alex Vukasin

Colleen Babington

Jon Petersen

Subbu Nabi

Subhalaxmi Nambi

Vijay Kumar

Yuko Oku

- GRAIL is on track to achieve **20% to 30% revenue growth** in 2025, having already seen **22% revenue growth** and **30% utilization growth** in the first half of the year.  **[1699031_2155747_0]** 
- The Medicare Multi-Cancer Early Detection (MCED) Act, which would grant Medicare statutory authority for FDA-approved MCED tests, is the **most supported healthcare bill in Congress** with bipartisan and bicameral support.  **[1699031_2155747_1]** 
- GRAIL plans to submit its FDA submission package for Galleri in the **first half of 2026**, with an expected approval approximately **one year after submission**.  **[1699031_2155747_5]** **[1699031_2155747_8]** 
- Galleri is highlighted as the **only MCED test fully validated in the intended-use population**, demonstrating a **0.5% false positive rate** compared to CancerGuard's **2.5%**.  **[1699031_2155747_3]** 
- **25% of Galleri's volume in Q2 2025** came from repeat testing, a rate GRAIL views as sustainable and impressive.  **[1699031_2155747_7]**

GRAIL Reports Strong 2025 Growth and Outlines Regulatory Pathway

- GRAIL will present new data on its Galleri® multi-cancer early detection (MCED) test from the **PATHFINDER 2 study** at the European Society for Medical Oncology (ESMO) Congress 2025 (October 17-21, 2025), with these results slated for submission to the **FDA as part of the Galleri Premarket Approval Application (PMA)**.  **[1699031_20250923LA80415:0]** 
- Top-line results from the PATHFINDER 2 study demonstrated **substantially greater additional cancer detection** and a higher positive predictive value (PPV) compared to the first PATHFINDER study.  **[1699031_20250923LA80415:0]** 
- Further data from the **SYMPLIFY and REFLECTION studies**, focusing on symptomatic and veteran populations, will be presented at the Early Detection of Cancer Conference (EDCC) 2025 (October 21-23, 2025).  **[1699031_20250923LA80415:0]** 
- The Galleri test is highlighted as the **only available MCED test with demonstrated performance** in an intended use population, capable of detecting **more than 50 types of cancer**.  **[1699031_20250923LA80415:0]** **[1699031_20250923LA80415:1]**

GRAIL to Present Key Galleri Test Data and Pursue FDA Approval

GRAIL (GRAL)