Freenome to Present New Validation Data for Next-Generation CRC Screening Test in Late-Breaking Oral Presentation at ACG 2026

The updated test maintained colorectal cancer detection performance while improving sensitivity for lesions with high-grade dysplasia.

Rhea-AI Summary

Freenome (FRNM) reported clinical validation results showing improved detection of advanced precancerous lesions with its updated SimpleScreen CRC blood-based screening test.

Sensitivity, the share of cases detected, rose to 18.2% for advanced precancerous lesions from 13.7% in the original PREEMPT CRC study. For lesions with high-grade dysplasia, sensitivity improved to 41.9% from 30.5%. Detection improved across all lesion subtypes. Colorectal cancer sensitivity remained consistent with the first version at 80.4%; specificity, the share correctly testing negative, was 90% among people with no colonoscopy findings.

Detailed results will be presented at ACG on October 14, 2026. The first-generation test received FDA approval in July 2026 and launched commercially in the United States through Abbott Cancer Diagnostics in late September.

5 points · 1 major

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0 major · 0 points

How the balance works

Positive

• Major pointFirst-generation SimpleScreen CRC received FDA approval in July 2026.
• Moderate pointAdvanced precancerous lesion sensitivity improved to 18.2% from 13.7% in the original PREEMPT CRC study.
• Moderate pointFirst-generation SimpleScreen CRC launched commercially in the United States through Abbott Cancer Diagnostics in late September.
• Minor pointHigh-grade dysplasia lesion sensitivity improved to 41.9% from 30.5% previously reported.
• Minor pointDetection sensitivity improved across all advanced precancerous lesion subtypes.

Negative

• None.

Key Figures

APL sensitivity: 18.2% (vs. 13.7%) HGD APL sensitivity: 41.9% (vs. 30.5%) CRC sensitivity: 80.4% +1 more

APL sensitivity

18.2% (vs. 13.7%)

Updated test vs. original PREEMPT CRC study

HGD APL sensitivity

41.9% (vs. 30.5%)

Updated test vs. previously reported result

CRC sensitivity

80.4%

Updated test; reported at 90% specificity and consistent with the first version

Specificity

90%

For no findings on colonoscopy

Historical Context

1 past event · Latest: Jul 27

1 event

1. Jul 27

   CRC test approval

   24h Move

   +1.3%

   FDA approved the first-generation CRC test; PREEMPT reported 13.7% APL and 30.7% HGD sensitivity.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

high-grade dysplasia, specificity, cell-free dna, methylation

4 terms

high-grade dysplasia medical

"Sensitivity for APLs with high-grade dysplasia (HGD) improved to 41.9%"

High-grade dysplasia is a severe abnormal change in cells of a tissue that looks much closer to cancer than normal cells and carries a high risk of becoming invasive cancer if not treated. For investors, it matters because diagnosis, treatment, or clinical trial results involving high-grade dysplasia can directly affect regulatory decisions, projected medical costs, market demand for therapies, and the commercial outlook for companies developing diagnostics or treatments—much like spotting deep cracks in a building that require urgent repair.

specificity medical

"achieving 80.4% sensitivity at 90% specificity"

Specificity measures how well a diagnostic test or screening correctly identifies people who do not have a condition — the percentage of healthy cases the test labels as negative. Think of it as a smoke alarm that stays quiet when there’s no fire; high specificity means fewer false alarms. For investors, specificity affects regulatory approval, clinical adoption, follow-up costs, and the perceived reliability and market potential of medical products.

cell-free dna technical

"analyzes circulating cell-free DNA methylation patterns at single-base resolution"

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

methylation technical

"analyzes circulating cell-free DNA methylation patterns at single-base resolution"

Methylation is a chemical process where small tags called methyl groups attach to DNA or proteins, altering how genes are read without changing the underlying genetic code. Investors monitor methylation because patterns can serve as diagnostic markers, drug targets, or measures of treatment response in biotech and healthcare—think of them as sticky notes or light switches that change biological behavior and can affect a product’s development, approval and market value.

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– Significant performance improvement seen across all subtypes of advanced precancerous lesions, which are important to detect for potential colorectal cancer prevention –

– Overall detection of colorectal cancer remained consistent with test’s first version, achieving 80.4% sensitivity at 90% specificity –

BRISBANE, Calif., Oct. 11, 2026 (GLOBE NEWSWIRE) -- Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company developing blood-based tests, today announced the company will present late-breaking data on an updated version of its SimpleScreen™ CRC blood-based screening test at the American College of Gastroenterology (ACG) 2026 Annual Meeting in Nashville.

Freenome conducted a pivotal clinical validation study to assess the performance of assay and algorithm improvements for the updated version of SimpleScreen CRC. The FDA approved the first-generation version of SimpleScreen CRC in July 2026, and the test was commercially launched in late September in the United States by Freenome’s partner Abbott Cancer Diagnostics.

The updated test demonstrated 18.2% sensitivity for detecting advanced precancerous lesions (APLs), a significant improvement compared to the 13.7% sensitivity in the original PREEMPT CRC^® study.¹ Sensitivity for APLs with high-grade dysplasia (HGD) improved to 41.9% in the updated test, compared to 30.5% reported previously. The sensitivity results for APLs and APLs with HGD demonstrated in this study are the highest reported to date for any non-invasive screening blood test in a prospective registrational pivotal clinical study.

Sensitivity was also improved for all APL subtypes, including villous or tubulovillous; adenomas ≥ 10 mm; sessile serrated lesions/polyps ≥ 10 mm; and traditional serrated adenomas.

Overall, 80.4% sensitivity was demonstrated for detecting CRC. The results were adjusted to the age and sex distribution of the U.S. Census to better reflect the intended use population, and specificity for no findings on colonoscopy was 90%.

"These results suggest that our blood-based screening test may detect precancerous lesions with clinically meaningful sensitivity," said Aaron Elliott, Ph.D., CEO of Freenome. "The ability to continually improve performance through refinements to our assay and algorithm, as seen with these results, is a fundamental part of our up-versioning strategy. We believe this iterative methodology not only improves CRC APL performance but is also applicable across our multi-cancer pipeline. Combined with our personalized cancer detection approach, this is how we continue to expand blood-based screening into an accessible option for the millions of Americans who remain unscreened."

Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study, will present the detailed results.

Presentation title: Improved Sensitivity for Advanced Precancerous Lesions (APLs) Demonstrated in Clinical Validation of an Updated Colorectal Cancer (CRC) Screening Blood Test in an Average-Risk Population.

Date: Wednesday, Oct. 14
Time: 9:10-9:20 am
Session: Plenary Session 4B: Liver, Esophagus, CRC, IBD

About Freenome

Freenome is an early cancer detection company developing blood-based screening tests to identify cancer in its earliest, most treatable stages. The company’s proprietary multiomics discovery platform analyzes circulating cell-free DNA methylation patterns at single-base resolution alongside additional biomarkers to detect multiple cancers. Freenome’s development of SimpleScreen™ CRC for colorectal cancer screening and a pipeline of tests for lung cancer and additional indications is designed to increase cancer detection among millions of at-risk individuals. For more information, visit www.freenome.com.

Forward-Looking Statements

Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are making this statement for purposes of complying with those safe harbor provisions. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding SimpleScreen CRC’s impact and ability to reach additional patients; the impact of FDA approval including with respect to Medicare and ACS guidelines; Freenome’s partnership with Abbott and the expected results and benefits thereof; and Freenome’s business and strategy, including its plans with respect to its broader SimpleScreen portfolio and multiomics platform. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks related to the approval of Freenome’s products and tests and the timing of expected regulatory and business milestones; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive products and tests; ability to obtain sufficient supply of materials; ability to obtain additional financing; ability to attract and retain qualified personnel; global economic and political conditions; legal and regulatory changes; the outcome of any legal proceedings that may be instituted against Freenome; the effects of competition on Freenome’s future business; as well as those set forth in Freenome’s most recent filings with the SEC, including our Form S-1. We assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

References
1. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. Published online June 2, 2025. doi: 10.1001/jama.2025.7515.

Contacts

Media contact
Ryan Flinn
The Grace Group
ryan@gracegroup.us

Investor contact
investor-relations@freenome.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much did Freenome's updated SimpleScreen CRC improve precancerous lesion detection?

Sensitivity for advanced precancerous lesions increased to 18.2%, compared with 13.7% in the original PREEMPT CRC study. For lesions with high-grade dysplasia, sensitivity increased to 41.9% from 30.5% previously reported.

What colorectal cancer detection results did Freenome's updated SimpleScreen CRC achieve?

The updated test achieved 80.4% sensitivity for colorectal cancer, consistent with the first-generation test. Specificity was 90% among people with no findings on colonoscopy.

How were Freenome's updated SimpleScreen CRC validation results adjusted?

The results were adjusted to the age and sex distribution of the U.S. Census to better reflect the intended-use population.