GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test

Rhea-AI Summary

GRAIL (Nasdaq: GRAL) submitted the final module of a Premarket Approval (PMA) application to the U.S. FDA on Jan 29, 2026 for the Galleri multi-cancer early detection test.

The filing cites performance and safety data from 25,490 PATHFINDER 2 participants and first-year data from the randomized NHS-Galleri trial, plus a bridging analysis to the PMA test version. Galleri received Breakthrough Device designation in 2018.

Positive

• Submitted final PMA module to FDA on Jan 29, 2026
• Includes data from 25,490 PATHFINDER 2 participants
• Supported by NHS-Galleri randomized controlled trial data
• Galleri designated a Breakthrough Device by FDA in 2018

Negative

• Submission is an application; FDA approval is not yet granted
• Bridging analysis indicates differences between trial versions and the PMA test version

Key Figures

PATHFINDER 2 participants: 25,490 participants NHS-Galleri trial round: First year Breakthrough Device year: 2018 +5 more

8 metrics

PATHFINDER 2 participants 25,490 participants US-based PATHFINDER 2 study with one-year follow up

NHS-Galleri trial round First year Prevalent screening round of NHS-Galleri randomized controlled trial

Breakthrough Device year 2018 Year FDA designated Galleri as a Breakthrough Device

Current share price $100.98 Price before PMA submission news

52-week high $118.84 Pre-news 52-week high level

52-week low $20.44 Pre-news 52-week low level

Price vs 52-week high 15.03% below Distance from 52-week high before news

Price vs 52-week low 394.03% above Gain from 52-week low before news

Market Reality Check

Price: $97.82 Vol: Volume 685,635 is below t...

normal vol

$97.82 Last Close

Volume Volume 685,635 is below the 20-day average of 834,287 (relative volume 0.82). normal

Technical Shares at $100.98, trading above the 200-day MA $59.71, 15.03% below the 52-week high of $118.84 and 394.03% above the 52-week low of $20.44.

Peers on Argus

Peers show mixed, mostly small moves: NEOG -1.45%, TWST -0.10%, OPK 0%, NEO 0%, ...

Peers show mixed, mostly small moves: NEOG -1.45%, TWST -0.10%, OPK 0%, NEO 0%, CDNA +1.27%. With GRAL down 0.02%, moves appear stock-specific rather than a coordinated sector reaction.

Historical Context

5 past events · Latest: Dec 15 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 15	Conference presentation	Neutral	-4.4%	Announcement of presentation at the 44th J.P. Morgan Healthcare Conference.
Dec 01	Equity compensation	Neutral	-0.9%	Inducement RSU grants to new non-executive employees under equity plan.
Nov 18	Conference presentation	Neutral	-4.1%	Planned presentation at Piper Sandler 37th Annual Healthcare Conference.
Nov 12	Earnings update	Positive	+1.6%	Q3 2025 results with revenue growth, higher Galleri volumes, strong cash runway.
Nov 04	Conference presentation	Neutral	+4.9%	Announcement of participation in Wolfe Research Healthcare Conference.

Pattern Detected

Recent news flow has been dominated by conferences and routine corporate updates, with generally modest price reactions. The one earnings release with revenue growth and narrowed losses saw a positive move, suggesting fundamentals-related news has tracked directionally with price, while event announcements have produced varied but contained reactions.

Recent Company History

Over the last few months, GRAIL’s disclosures focused on conferences, routine equity grants, and Q3 2025 results. The company reported Q3 2025 revenue of $36.2M and a net loss of $89.0M, with U.S. Galleri revenue at $32.6M and tests sold growing to more than 45,000. Capital strength was highlighted via a private placement of about $325M and a planned $110M Samsung investment, plus cash above $850M. Today’s PMA submission completes the Q1 2026 regulatory timeline previously indicated, tying directly to that earlier guidance.

Market Pulse Summary

This announcement marks submission of the final PMA module for Galleri, backed by data from 25,490 P...

Analysis

This announcement marks submission of the final PMA module for Galleri, backed by data from 25,490 PATHFINDER 2 participants and the first year of the NHS-Galleri trial. The test already holds FDA Breakthrough Device status from 2018. Historically, GRAIL’s stock has reacted modestly to conference updates and more constructively to fundamental milestones like Q3 2025 results and capital raises. Investors may track FDA review progress, future trial readouts, and commercialization updates as key next steps.

Key Terms

premarket approval, pma, u.s. food and drug administration, fda, +4 more

8 terms

premarket approval regulatory

"submission of the final module of the Premarket Approval (PMA) application to the U.S."

Premarket approval is the formal regulatory clearance required before certain medical devices can be sold, based on detailed evidence that the product is safe and effective. For investors, it’s a major milestone because receiving approval typically clears the way for commercial sales and reduces regulatory uncertainty, while failure or delays can block revenue and raise the risk profile; think of it like a safety certificate needed before a new car model can be sold.

pma regulatory

"final module of the Premarket Approval (PMA) application to the U.S. Food and Drug"

PMA stands for Premarket Approval, the U.S. Food and Drug Administration’s highest-level review for high-risk medical devices. It’s a thorough evaluation to confirm a device is safe and effective before it can be sold, like a final safety inspection and license to operate. Investors care because receiving PMA can open a significant revenue stream, while delays or rejection can postpone sales and reduce a company’s value.

u.s. food and drug administration regulatory

"application to the U.S. Food and Drug Administration (FDA) for its Galleri"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"application to the U.S. Food and Drug Administration (FDA) for its Galleri"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

breakthrough device regulatory

"The FDA designated the test as a Breakthrough Device in 2018."

'Breakthrough device' is a regulatory designation for a medical device judged to offer a substantial improvement in diagnosing or treating a serious or life‑threatening condition, granting it priority review and more intensive interaction with regulators to accelerate approval. For investors, it matters because the label can shorten time to market and reduce regulatory uncertainty—like putting a product into the fast lane—potentially raising commercial value and lowering development risk.

multi-cancer early detection medical

"for its Galleriae multi-cancer early detection (MCED) test."

A multi-cancer early detection test is a medical screening tool—often a simple blood test—that looks for biological signals, such as abnormal DNA or protein patterns, that could indicate many different cancers before symptoms appear. For investors it matters because successful tests can reshape demand for diagnostics, influence healthcare spending and insurance coverage, and create new revenue streams or risks for companies across diagnostics, treatment and screening services; think of it as a smoke alarm that can warn of problems throughout an entire house rather than just one room.

mced medical

"for its Galleriae multi-cancer early detection (MCED) test."

A multi-cancer early detection (MCED) test is a blood-based screening tool designed to detect signs of many different cancers from a single sample, often before symptoms appear. For investors, MCEDs matter because they represent a potential shift from disease-by-disease screening to a one-stop early-warning test, which could unlock large markets, change clinical practice, and carry regulatory, reimbursement and adoption risks similar to other breakthrough medical technologies; think of it as a smoke alarm that tries to spot many types of fires early.

randomized, controlled trial medical

"NHS-Galleri trial, the largest, and only, randomized, controlled trial of any MCED"

A randomized, controlled trial assigns participants by chance into two or more groups—one receiving the treatment being tested and the other receiving a standard treatment or placebo—so outcomes can be fairly compared. Think of it like flipping a coin to place people into different teams to avoid bias; investors use results from these trials as strong evidence about a drug or medical device’s real benefits and risks, which can materially affect regulatory approval, market potential, and company value.

AI-generated analysis. Not financial advice.

FDA Submission Marks a Pivotal Milestone in Advancing Early Cancer Detection, Addressing Unmet Needs in Cancer Screening

MENLO PARK, Calif., Jan. 29, 2026  /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri^® multi-cancer early detection (MCED) test. The FDA designated the test as a Breakthrough Device in 2018.

"Cancer is now the leading killer of adults over 50 years old in the U.S., and most deadly cancers are often discovered too late, when they are difficult to treat and typically have worse outcomes," said Josh Ofman, MD, MSHS, President at GRAIL. "There is nothing acceptable about the status quo in cancer screening. Adding Galleri to standard-of-care single cancer screening tests has the potential to dramatically improve the performance of the nation's current screening program and expand opportunities for earlier treatment and improved outcomes. Galleri has been rigorously studied in case-controlled and interventional studies. This FDA submission marks a critical step toward making Galleri available to more people and advancing early detection to provide a significant public health benefit."

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.

About the NHS-Galleri trial (NCT05611632)
The NHS-Galleri trial is the first and only prospective, randomized, controlled trial to assess the clinical utility and performance of a multi-cancer early detection test for population screening when added to standard care. The trial recruited more than 140,000 asymptomatic participants, aged 50 to 77, and was conducted in partnership with the NHS in England. Participants provided three blood samples over two years, about 12 months apart. The primary objective of the NHS-Galleri trial is to show a reduction in late-stage (III-IV) cancers in people who received the Galleri test compared with those who did not. This will be measured in three clinically important groups of cancers, focusing first in a pre-specified group of 12 cancer types that together represent approximately two-thirds of cancer deaths in England and the United States. Secondary objectives include reduction in stage IV cancer; performance of the Galleri test, including positive predictive value and false positive rate; cancer detection rate; safety; and healthcare resource utilization.

About the PATHFINDER 2 Study (NCT05155605)
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and performance of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes over several time points, including an assessment of participants' anxiety and satisfaction with the MCED test.

About GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's 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. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom.  
For more information, visit grail.com. 

Forward Looking Statements 
This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about GRAIL, Inc. (the "Company"), include the benefits and use of the Galleri test, the potential of the Galleri MCED test, including its benefits alongside standard of care screening, upcoming events and presentations, the sufficiency of the PMA submission package, including the results of the NHS-Galleri, PATHFINDER 2 and bridging analysis, for approval by the FDA, potential labeling in any approved PMA, planned commercial use of the PMA version of Galleri, if and when approved, and the timeline for review and approval of the PMA submission by the FDA. 

These statements are only predictions based on the Company's current expectations and projections about future events and trends. There are important factors that could cause actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the period ended December 31, 2024 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2025, June 30, 2025 and September 30, 2025. Moreover, the Company operates in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for the Company's management to predict all risks, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements. 

Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Although the Company believes the expectations and projections expressed or implied by the forward-looking statements are reasonable, it cannot guarantee future results, level of activity, performance, or achievements. Actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, the Company undertakes no obligation to update any of these forward-looking statements after the date of this press release to conform prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events. 

References

1. American Cancer Society. Cancer Facts & Figures 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html
2. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings. [cited 2025 Dec 19]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results?topic%20status=All&grades%5B%5D=A&grades%5B%5D=B&grades%5B%5D=C&category%5B%5D=15&searchterm= 
3. Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806.
4. GRAIL, Inc. Analysis of cancer registration statistics: cancer mortality in England, 2019 and 2020. [Data on file: UK-2023-0117].
5. GRAIL, Inc. American Cancer Society. Cancer facts & figures 2025. [Data on file: GA-2021-0065].
6. Sasieni P, Swanton C, Neal R. Advanced cancer: a robust surrogate of cancer mortality in early detection trials?, Ann Oncol. 2025 June;36(6):706-708. doi:10.1016/j.annonc.2025.03.001.
7. Nabavizadeh N, et al. Safety and Performance of a Multi-Cancer Early Detection (MCED) Test in an Intended-Use Population: Initial Results from the Registrational PATHFINDER 2 Study. Proffered Presentation Presented at: European Society for Medical Oncology (ESMO) Annual Meeting; October 17-21, 2025; Berlin, Germany.
8. GRAIL, Inc. False positive rate. [Data on file: GR-2025-0256].
9. Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multi-cancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402:1251-1260. doi:10.1016/S0140-6736(23)01700-2.
10. GRAIL, Inc. Enhanced Cancer Signal Origin prediction. [Data on file: VV-TMF-59592].
11. Hackshaw A, et al. New genomic technologies for multi-cancer early detection: Rethinking the scope of cancer screening. Cancer Cell. 2022;40(2):109-13. doi:10.1016/j.ccell.2022.01.012.  

 

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SOURCE GRAIL, Inc.

FAQ

What did GRAIL (GRAL) submit to the FDA on January 29, 2026?

GRAIL submitted the final module of a PMA application to the FDA for Galleri on Jan 29, 2026. According to the company, the filing includes PATHFINDER 2 data from 25,490 participants, first-year NHS-Galleri randomized trial data, and a bridging analysis to the PMA test version.

How much clinical data supports the GRAL PMA submission for Galleri?

The submission is supported by performance and safety results from 25,490 PATHFINDER 2 participants. According to the company, it also includes data from the prevalent (first-year) round of the randomized NHS-Galleri trial and a bridging analysis.

What is the significance of the NHS-Galleri trial in GRAIL's PMA for GRAL?

NHS-Galleri is the largest randomized, controlled trial cited in the PMA submission and provides first-year screening data. According to the company, this trial is the only randomized controlled trial of any MCED test in an intended-use population.

Does the PMA submission mean Galleri is FDA approved for GRAL shareholders?

No; submission does not equal approval and review is pending with the FDA. According to the company, the PMA filing is a critical regulatory step but does not guarantee a favorable or timely decision.

Why did GRAIL include a bridging analysis in the GRAL PMA filing?

The bridging analysis compares versions used in PATHFINDER 2 and NHS-Galleri to the updated PMA test version. According to the company, this is intended to demonstrate performance consistency between studied versions and the submitted PMA version.