GRAIL Submits Final PMA Application for Galleri Multi-Cancer Early Detection Test
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5d ago
0mins
Should l Buy GRAL?
GRAIL "announced the submission of the final module of the Premarket Approval application to the U.S. Food and Drug Administration for its Galleri(R) multi-cancer early detection test. The FDA designated the test as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants in the US-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled trial of any MCED test in an intended use population. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval."
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Analyst Views on GRAL
Wall Street analysts forecast GRAL stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for GRAL is 60.86 USD with a low forecast of 38.00 USD and a high forecast of 83.71 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
1 Buy
2 Hold
0 Sell
Moderate Buy
Current: 105.420
Low
38.00
Averages
60.86
High
83.71
Current: 105.420
Low
38.00
Averages
60.86
High
83.71
About GRAL
Grail, Inc. is a healthcare company focused on saving lives and shifting the paradigm in early cancer detection. The Company is focused on alleviating the global burden of cancer by using sequencing, population-scale clinical studies, and machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. Its targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. Its multi-cancer early detection test, the Galleri test, is a commercially available screening test for early detection of multiple types of cancer. The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Pricing Strategy: The test is offered at a $250 discount for customers enrolled in the company's Labs plans, aiming to attract more users to participate in cancer screening and enhance the company's competitive position in the health tech sector.
- Market Demand Response: HIMS CEO Andrew Dudum emphasized that despite significant advancements in cancer screening technology, many diagnoses should have been made earlier, indicating a pressing market need for innovative detection tools that could drive future growth for the company.
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- Clinical Trial Data: The submission is based on safety and performance results from the PATHFINDER 2 study involving 25,490 participants, demonstrating the effectiveness of the Galleri test in early cancer detection and potentially expanding opportunities for earlier treatment.
- NHS-Galleri Trial: This trial is the world's first prospective randomized controlled trial, recruiting over 140,000 asymptomatic participants to assess the Galleri test's impact on reducing late-stage cancers, highlighting its significant public health implications.
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- Clinical Trial Support: The submission is backed by results from the PATHFINDER 2 study involving 25,490 participants, demonstrating the safety and efficacy of the Galleri test, which could open new avenues for early treatment.
- NHS-Galleri Trial Scale: The NHS-Galleri trial recruited over 140,000 asymptomatic participants to assess the impact of the Galleri test on reducing late-stage cancers, highlighting its significant public health implications.
- Innovative Technology Potential: The Galleri test employs advanced genomic sequencing and machine learning technologies aimed at early detection of multiple deadly cancers, potentially reducing cancer mortality rates and improving patient survival outcomes.
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- Product Launch: Hims & Hers Health has announced the launch of the Galleri multi-cancer early detection test developed by GRAIL, designed to identify over 50 types of cancer through blood testing before symptoms appear, although it may produce false positives and negatives.
- Pricing Strategy: The test is offered at a $250 discount for customers enrolled in the company's Labs plans, aiming to attract more users to participate in cancer screening and enhance the company's competitive position in the health tech sector.
- Market Demand Response: HIMS CEO Andrew Dudum emphasized that despite significant advancements in cancer screening technology, many diagnoses should have been made earlier, indicating a pressing market need for innovative detection tools that could drive future growth for the company.
- Strategic Implications: By launching the Galleri test, Hims & Hers not only showcases its innovative capabilities in telehealth but also has the potential to enhance customer loyalty by improving cancer screening rates, thereby creating long-term value for the company.
See More
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- FDA Submission: GRAIL has submitted the final module of its Galleri multi-cancer early detection test to the FDA, marking a pivotal milestone in the cancer screening landscape, which is expected to significantly improve the current state of cancer screening in the U.S.
- Clinical Trial Data: The submission is based on safety and performance results from the PATHFINDER 2 study involving 25,490 participants, demonstrating the effectiveness of the Galleri test in early cancer detection and potentially expanding opportunities for earlier treatment.
- NHS-Galleri Trial: This trial is the world's first prospective randomized controlled trial, recruiting over 140,000 asymptomatic participants to assess the Galleri test's impact on reducing late-stage cancers, highlighting its significant public health implications.
- Technological Innovation: GRAIL leverages next-generation sequencing and machine learning technologies to detect cancer at earlier stages through the Galleri test, aiming to reduce cancer mortality rates and improve patient outcomes.
See More
GRAIL Submits FDA Application to Advance Early Cancer Detection
- FDA Submission: GRAIL has submitted the final module of its Galleri multi-cancer early detection test to the FDA, marking a pivotal milestone in cancer screening that is expected to significantly enhance the effectiveness of cancer detection in the U.S.
- Clinical Trial Support: The submission is backed by results from the PATHFINDER 2 study involving 25,490 participants, demonstrating the safety and efficacy of the Galleri test, which could open new avenues for early treatment.
- NHS-Galleri Trial Scale: The NHS-Galleri trial recruited over 140,000 asymptomatic participants to assess the impact of the Galleri test on reducing late-stage cancers, highlighting its significant public health implications.
- Innovative Technology Potential: The Galleri test employs advanced genomic sequencing and machine learning technologies aimed at early detection of multiple deadly cancers, potentially reducing cancer mortality rates and improving patient survival outcomes.
See More
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- Tesla Innovation: Tesla's latest advancements in the robotaxi sector have garnered market attention, expected to create new revenue streams and strengthen its competitive edge in the electric vehicle market.
- Intel's Decline: In contrast, Intel's stock tumbled late in the trading session, reflecting market concerns about its future growth prospects, which could impact investor confidence in tech stocks overall.
- Industry Dynamics: Tesla's success may prompt other electric vehicle manufacturers to accelerate their development of autonomous driving technologies, potentially reshaping the competitive landscape and driving technological advancements across the industry.
See More
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- Stock Surge: Grail's shares rose over 13% to $13.68 by this afternoon, reflecting investor optimism about the company's 2026 prospects, particularly following an upbeat presentation at the JPMorgan Healthcare Conference.
- Revenue Guidance: Management projects total revenue for 2025 to be between $147 million and $148 million, with the Galleri test expected to contribute $136 million to $137 million, indicating strong market performance and growth potential.
- Cash Burn Management: Grail's cash burn is projected to decrease to $274 million in 2025 from $579 million in 2024, and with a cash position of $904 million, the company is well-positioned to operate until 2030, boosting investor confidence.
- FDA Submission Plans: Grail plans to submit a Premarket Approval (PMA) application to the FDA in Q1, which, if approved, would provide medical and insurance coverage for the Galleri test, facilitating marketing efforts and physician adoption, thereby enhancing the company's market position.
See More
