Freenome Expands Personalized Cancer Detection Portfolio, Launching SimpleScreen™ Lung Test With FDA-Approved SimpleScreen CRC Option

Eligible patients can order the lung test alone or add FDA-approved colorectal cancer screening through the same blood draw.

Rhea-AI Summary

Freenome (FRNM) launched SimpleScreen Lung, enabling eligible patients to combine lung and colorectal cancer screening in a single blood draw. The laboratory-developed lung test is intended for adults ages 50 to 80 with a ≥20 pack-year smoking history who are not participating in guideline-recommended screening. It can be ordered alone or with FDA-approved SimpleScreen CRC for eligible average-risk patients.

In an independent case-control cohort of 172 lung cancer cases and 436 controls, SimpleScreen Lung achieved 85% sensitivity at 50% specificity and a 99.8% negative predictive value. Performance estimates were adjusted for target population characteristics. The lung test has not been reviewed or cleared/approved by the FDA. SimpleScreen CRC is approved for average-risk adults 45 and older and meets Medicare coverage criteria. Abbott holds exclusive U.S. commercial rights to standalone SimpleScreen CRC orders.

7 points · 0 major

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Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 2 points

How the balance works

Positive

• Moderate pointSimpleScreen Lung's launch adds combined lung and colorectal screening through one blood draw for eligible patients.
• Minor pointLung cancer detection sensitivity reached 85% in an independent cohort of 172 cases and 436 controls.
• Minor pointStage-specific lung sensitivity was 82%, 75%, 91% and 94% for stages I, II, III and IV, respectively.
• Minor pointLung test 99.8% negative predictive value means about two per 1,000 negative results would be expected to have cancer.
• Minor pointSimpleScreen CRC has FDA approval for average-risk adults 45 and older, ACS guideline inclusion and Medicare coverage eligibility.

2 minor points

• Minor pointPREEMPT CRC, enrolling more than 48,000 participants, showed 81% CRC sensitivity after age-and-sex adjustment.
• Minor pointCRC specificity for advanced colorectal neoplasia reached 90%, with 99.9% negative predictive value, after age-and-sex adjustment.

Negative

• Moderate pointStandalone SimpleScreen CRC commercialization in the U.S. is subject to Abbott's exclusive rights.
• Minor pointSimpleScreen Lung specificity was 50% in the independent cohort, limiting its ability to identify controls as negative.

Key Figures

Lung test sensitivity: 85% sensitivity at 50% specificity Lung test negative predictive value: 99.8% Independent cohort: 172 lung cancer cases and 436 controls +3 more

Lung test sensitivity

85% sensitivity at 50% specificity

SimpleScreen Lung independent cohort

Lung test negative predictive value

99.8%

SimpleScreen Lung independent cohort

Independent cohort

172 lung cancer cases and 436 controls

SimpleScreen Lung validation

CRC sensitivity

81%

PREEMPT CRC study

Specificity for advanced colorectal neoplasia

90%

PREEMPT CRC study

CRC negative predictive value

99.9%

PREEMPT CRC analysis adjusted to the 2020 U.S. Census age and sex distribution

Historical Context

2 past events · Latest: Aug 12

2 events

1. Aug 12

   FDA designation

   24h Move

   -3.8%

   FDA granted Breakthrough Device Designation to SimpleScreen Lung for eligible high-risk adults.

2. Jul 27

   FDA approval

   24h Move

   +1.3%

   FDA approved SimpleScreen CRC, with Abbott set to commercialize the test in the U.S.

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

Key Terms

negative predictive value, specificity, cell-free dna, low-dose computed tomography, +1 more

5 terms

negative predictive value medical

"a 99.8% negative predictive value (NPV)"

Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.

specificity medical

"85% sensitivity at 50% 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 medical

"detects signals associated with CRC from cell-free DNA (cfDNA) in the blood"

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.

low-dose computed tomography medical

"low-dose computed tomography (LDCT), the standard-of-care screening method"

A low-dose computed tomography (LDCT) scan is a medical imaging test that uses small amounts of X-ray radiation to create detailed cross-sectional pictures of the body, often described like slicing a loaf of bread to examine each slice. For investors, LDCT matters because its use in screening programs (for example, detecting lung disease early) drives demand for imaging equipment, clinical services, regulatory approval, reimbursement policies and adoption by healthcare providers, all of which affect companies that make or operate diagnostic tools and related services.

laboratory-developed test regulatory

"SimpleScreen Lung is a laboratory-developed test intended for adults ages 50 to 80"

A laboratory-developed test is a diagnostic test that a single clinical laboratory designs, builds and uses in its own facility rather than buying from an outside manufacturer; think of it as a custom recipe made and run in-house for diagnosing disease. Investors care because these tests can be quicker to bring to market and create a revenue stream for labs, but they also carry regulatory and quality-risk differences that can affect demand, reimbursement and legal exposure.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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– Personalized Cancer Detection provides flexible approach to cover multiple types of cancer screening in a single blood draw –

– In an independent cohort, SimpleScreen Lung showed 85% sensitivity at 50% specificity and a 99.8% negative predictive value for lung cancer in its intended use population –

BRISBANE, Calif., Oct. 20, 2026 (GLOBE NEWSWIRE) -- Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company developing blood-based tests, today announced the launch of SimpleScreen™ Lung and a first-of-its-kind offering that enables eligible patients to be screened for both lung and colorectal cancer (CRC) through a single blood draw, using two independently validated, indication-specific tests. Freenome's Personalized Cancer Detection (PCD) approach combines risk-based screening with a portfolio of single-cancer and multi-cancer tests that are developed specifically for each population and to meet individual patient screening needs.

SimpleScreen Lung is a laboratory-developed test intended for adults ages 50 to 80 with a ≥20 pack-year smoking history who are not currently participating in guideline-recommended screening. It can be ordered independently or alongside the FDA-approved SimpleScreen™ CRC test when average-risk patients are also eligible for blood-based CRC screening. Together, these tests offer patients and providers an opportunity to address one or both screening needs in a single encounter, with the potential to expand access and improve screening participation.

Lung cancer is the leading cause of cancer death in the United States, and less than 20% of people (more than 10 million individuals) eligible for lung cancer screening are up to date with low-dose computed tomography (LDCT), the standard-of-care screening method.¹ Colorectal cancer is the second leading cause of cancer death,^2,3 and nearly two in five eligible adults – up to 60 million people in the U.S. – are not up to date with CRC screening.⁴

“Lung cancer screening can save lives, but its potential depends on reaching people who are eligible,” said Douglas Flora, M.D., the executive medical director of oncology services for St. Elizabeth Healthcare in Kentucky and president-elect of the Association of Cancer Care Centers. “When so many people are not up to date, we need to understand what is keeping them from participating and consider new approaches. A blood-based test adds a practical option to our patient conversations and helps us make progress toward our goal of connecting more eligible people with screening and getting them to take the next step.”

SimpleScreen Lung was clinically validated in a case-control study of adults ages 50 to 80 with a ≥20 pack-year smoking history who meet American Cancer Society (ACS) lung cancer screening eligibility.⁵ In an independent cohort of 172 lung cancer cases and 436 controls, the test achieved 85% sensitivity at 50% specificity and a 99.8% negative predictive value (NPV). This NPV means that about two of every 1,000 people with a negative result would be expected to have lung cancer. Sensitivity was 82% for stage I, 75% for stage II, 91% for stage III, and 94% for stage IV.

Performance estimates were adjusted to reflect target distributions of age, sex, lung cancer stage and histologic subtype. The intended use population includes former smokers regardless of how long ago they quit, consistent with the 2023 ACS lung cancer screening guideline update.

A person who qualifies for lung cancer screening may also be eligible for CRC screening. During a patient visit, a provider can discuss both screening needs and, when appropriate, add SimpleScreen CRC to a SimpleScreen Lung order. The Freenome-developed SimpleScreen CRC is FDA-approved for adults 45 and older at average risk, is included in the ACS CRC screening guideline, and meets Medicare coverage criteria. Abbott has exclusive U.S. commercial rights to SimpleScreen CRC when it is ordered as a standalone test. In the PREEMPT CRC® study, which enrolled more than 48,000 participants, the test demonstrated 81% sensitivity for CRC, 90% specificity for advanced colorectal neoplasia, and a 99.9% NPV in an analysis adjusted to the 2020 U.S. Census age and sex distribution.⁶

“SimpleScreen CRC proved what our discovery platform can achieve for colorectal cancer screening, and expanding into lung cancer screening is the next step in extending this science to broader patient populations," said Aaron Elliott, Ph.D., CEO of Freenome. "By coupling indication-specific screens together, we make it vastly easier for patients to say yes to screening. As our portfolio grows, Personalized Cancer Detection will offer clinicians more screening options and enable health systems to provide more comprehensive coverage without adding complexity to existing clinical workflows.”

Freenome will be introducing the SimpleScreen portfolio and the PCD approach to attendees at booth 2705 at the American Academy of Family Physicians Family Medicine Experience (FMX) conference, Oct. 20 to 24 in Nashville.

About the SimpleScreen Portfolio

SimpleScreen CRC is a cancer screening option for colorectal cancer. It uses a simple blood draw and detects signals associated with CRC from cell-free DNA (cfDNA) in the blood. The test is indicated for adults aged 45 years and older who are at average risk for CRC and referred by a healthcare provider for CRC screening. A positive result indicates a signal was detected that may suggest the presence of colorectal cancer or advanced precancerous lesions and should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.

The SimpleScreen Lung laboratory-developed test has not been reviewed or cleared/approved by the U.S. Food and Drug Administration (FDA).

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 portfolio and Personalized Cancer Detection’s impact and ability to reach additional patients. 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 the S-1 that was filed with the SEC, as updated by our subsequently filed SEC filings. We assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

References
1. Centers for Disease Control and Prevention. Screening for Lung Cancer. Last updated May 12, 2026. Accessed Oct. 7, 2026 at https://www.cdc.gov/lung-cancer/screening/index.html
2. Siegel RL, Kratzer TB, Wagle NS, Sung H, Jemal A. Cancer statistics, 2026. CA Cancer J Clin. 2026;76(1):e70043. doi:10.3322/caac.70043.
3. DW, Kisiel JB, Fendrick AM, et al. Estimated Average-Risk Colorectal Cancer Screening-Eligible Population in the US. JAMA Netw Open. 2024;7(3):e245537.
4. King SC, King J, Thomas CC, Richardson LC. Baseline estimates of colorectal cancer screening among adults aged 45 to 75 years, Behavioral Risk Factor Surveillance System, 2022. Prev Chronic Dis. 2025;22:250175. doi:10.5888/pcd22.250175.
5. Freenome, LLC. Data on file.
6. 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.

Who is eligible for Freenome's SimpleScreen Lung test?

SimpleScreen Lung is intended for adults ages 50 to 80 with a ≥20 pack-year smoking history who are not currently participating in guideline-recommended screening. Former smokers qualify regardless of how long ago they quit, consistent with the 2023 American Cancer Society lung screening guideline update.

What did Freenome's SimpleScreen Lung validation study show?

The independent cohort showed 85% sensitivity at 50% specificity and a 99.8% negative predictive value. Sensitivity measures how often a test detects cancer in people who have it; specificity measures how often it correctly identifies people without it. Performance estimates were adjusted for target distributions of age, sex, lung cancer stage and histologic subtype.

What follow-up is required after a positive Freenome SimpleScreen CRC result?

A positive SimpleScreen CRC result should be followed by colonoscopy. A positive result indicates a detected signal that may suggest colorectal cancer or advanced precancerous lesions. The test does not replace diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.