Freenome, Inc. (FRNM) secures FDA OK for SimpleScreen CRC and $100M from Abbott
Rhea-AI Filing Summary
Freenome, Inc. has received FDA approval for SimpleScreen™ CRC, a blood-based screening test for colorectal cancer in adults aged 45 and older at average risk. The test analyzes cell-free DNA using AI/ML technology and was validated in the PREEMPT CRC study of more than 48,000 participants at over 200 sites.
In a prespecified analysis, SimpleScreen CRC showed 81.1% sensitivity for colorectal cancer, 13.7% sensitivity for advanced precancerous lesions (30.7% with high-grade dysplasia), and 90.4% specificity for advanced colorectal neoplasia. With approval, the test meets Medicare coverage criteria and is expected to be named in American Cancer Society guidelines, supporting broader access.
Under an August 2025 commercial agreement, Abbott will exclusively commercialize SimpleScreen CRC in the U.S. and will pay Freenome a $100 million milestone tied to this FDA approval. The product is the first commercial milestone in Freenome’s Personalized Cancer Detection strategy and will be integrated into its broader SimpleScreen portfolio and multiomics-based pipeline.
Positive
- FDA approval of SimpleScreen CRC creates Freenome’s first commercial product and triggers a $100 million milestone payment from Abbott.
- Exclusive U.S. commercialization by Abbott leverages its existing colorectal cancer screening infrastructure to help expand access to blood-based CRC screening.
Negative
- None.
Filing Explained
FDA approval is complete and tied to a future 100 million dollar Abbott milestone; exclusive U.S. commercialization is planned for fall 2026.
On
The test is indicated for adults 45 and older at average risk who are referred by a healthcare provider; a positive result should be followed by colonoscopy, and the product is not a replacement for diagnostic or surveillance colonoscopy in high-risk people.
Abbott’s role is exclusive U.S. commercialization, while Freenome’s
At
The filing leaves the commercialization date at “this fall”; Medicare coverage criteria are described as met, while American Cancer Society guideline inclusion remains expected.
Sources and calculations
- Freenome Form 8-K and Exhibit 99.1 (2026-07-27)
- Form 8-K purpose (current)
- Perceptive Capital Solutions Corp. latest quarterly fundamentals (2026Q2)
- Cash and equivalents vs quarterly operating cash outflow, in days of cash use $437,369 / ($129,810 / 90) = [object Object]
8-K Event Classification
3 items: 7.01, 8.01, 9.01
3 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Milestone payment from Abbott: $100 million
Colorectal cancer sensitivity: 81.1% sensitivity
Advanced precancerous lesion sensitivity: 13.7% sensitivity
+3 more
6 metrics
Milestone payment from Abbott
$100 million
Payable to Freenome upon FDA approval of SimpleScreen CRC
Colorectal cancer sensitivity
81.1% sensitivity
Detection of colorectal cancer in prespecified PREEMPT CRC analysis
Advanced precancerous lesion sensitivity
13.7% sensitivity
Detection of advanced precancerous lesions in PREEMPT CRC
High-grade dysplasia APL sensitivity
30.7% sensitivity
Detection of APLs with high-grade dysplasia in PREEMPT CRC
Specificity for advanced colorectal neoplasia
90.4% specificity
Specificity reported for SimpleScreen CRC in PREEMPT CRC
PREEMPT CRC enrollment
more than 48,000 adults
Asymptomatic, average-risk adults aged 45–85 enrolled for validation
Key Terms
cell-free DNA, multiomics, advanced precancerous lesions, specificity, +2 more
6 terms
cell-free DNA medical
"SimpleScreen CRC detects signals from cell-free DNA 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.
multiomics technical
"tests built on the same multiomics platform"
Multiomics is the combined analysis of different biological data types — such as genes, proteins and small‑molecule chemicals — to build a complete picture of how cells or organisms function. For investors, multiomics matters because it can make drug and diagnostic development more precise and faster by revealing causes, predicting who will benefit from a therapy, and reducing downstream clinical trial surprises — like using multiple camera angles to better understand a complex scene.
advanced precancerous lesions medical
"detected advanced precancerous lesions (APLs) with 13.7% sensitivity"
specificity medical
"The test showed 90.4% specificity for advanced colorectal neoplasia"
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.
Personalized Cancer Detection medical
"first commercial milestone in Freenome’s Personalized Cancer Detection approach"
PREEMPT CRC medical
"evaluated in PREEMPT CRC, the largest prospective clinical validation study"
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What FDA approval did Freenome (PCSC) announce regarding SimpleScreen CRC?
Freenome announced FDA approval of SimpleScreen™ CRC, a blood-based colorectal cancer screening test for adults 45 and older at average risk. The test uses cell-free DNA and AI/ML analysis and is intended for use following referral by a healthcare provider for CRC screening.
How effective is Freenome (PCSC) SimpleScreen CRC according to the PREEMPT CRC study?
SimpleScreen CRC showed 81.1% sensitivity for colorectal cancer and 13.7% sensitivity for advanced precancerous lesions, including 30.7% for high-grade dysplasia. It demonstrated 90.4% specificity for advanced colorectal neoplasia in a large validation study of more than 48,000 asymptomatic, average-risk adults.
What milestone payment will Freenome (PCSC) receive from Abbott after FDA approval?
Under their August 2025 commercial agreement, Freenome will receive a $100 million milestone payment from Abbott tied to FDA approval of SimpleScreen CRC. This payment accompanies Abbott’s exclusive U.S. commercialization rights for the test and marks Freenome’s first major commercial milestone.
Who will commercialize SimpleScreen CRC in the U.S. and when will it launch?
Abbott will exclusively commercialize SimpleScreen CRC in the U.S., with launch planned for this fall. Abbott will add the blood-based test to its colorectal cancer screening portfolio, leveraging its provider relationships, reimbursement expertise and patient support programs developed through Cologuard.
Which patients is Freenome (PCSC) SimpleScreen CRC intended to screen?
SimpleScreen CRC is indicated for adults aged 45 and older at average risk for colorectal cancer who are referred by a healthcare provider for screening. A positive result indicates a signal that may suggest colorectal cancer or advanced precancerous lesions and should be followed by colonoscopy.
How many people could benefit from Freenome (PCSC) SimpleScreen CRC screening?
The companies note that up to 60 million Americans remain overdue for recommended colorectal cancer screening. By offering a simple blood draw option, SimpleScreen CRC is intended to reach more unscreened individuals and support earlier colorectal cancer detection and prevention.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 27, 2026
(Exact name of registrant as specified in its charter)
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446-6630
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure
On July 27, 2026, Freenome, Inc. (the “Company”) issued a press release titled “FDA Approves Freenome’s SimpleScreen™ CRC Blood-Based Screening Test; Abbott to Commercialize
in the U.S.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be
deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01. Other Events
On July 27, 2026, the Company announced that the U.S. Food and Drug Administration (“FDA”) has approved SimpleScreen™ CRC, a new blood-based screening option for colorectal
cancer (“CRC”) in adults 45 and older who are at average risk for the disease.
Colorectal cancer is the second-leading cause of cancer-related death in the U.S., but it is highly preventable and treatable when detected early through screening. Up to 60
million Americans remain overdue for recommended screening, underscoring the need for additional convenient screening approaches that can help reach more people.
SimpleScreen CRC detects signals associated with colorectal cancer from cell-free DNA in the blood. FDA approval reflects years of clinical research, AI/ML-driven technology
development and extensive collaboration with investigators, healthcare providers and partners.
SimpleScreen CRC was evaluated in PREEMPT CRC, the largest prospective clinical validation study ever conducted for a blood-based colorectal cancer screening test. Conducted
at over 200 sites, PREEMPT CRC enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45 and 85 who were scheduled for a screening colonoscopy. In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC
detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions (“APLs”) with 13.7% sensitivity, including 30.7% for APLs with high-grade dysplasia. The test showed 90.4% specificity for advanced colorectal neoplasia. In practical
terms, the test correctly detected about 8 in 10 colorectal cancers while correctly producing negative results for 9 of 10 people without colorectal cancer or advanced precancerous lesions.
With FDA approval, SimpleScreen CRC meets the coverage criteria for Medicare and is expected to be incorporated into the American Cancer Society guidelines by name. Together,
we believe these milestones will help expand access to blood-based CRC screening for eligible adults.
Under the terms of the commercial agreement signed between Freenome and Abbott in August 2025, Freenome will receive a $100 million milestone payment from Abbott for this FDA
approval. Abbott will exclusively commercialize SimpleScreen CRC in the U.S., building on the provider relationships, reimbursement expertise and patient support programs it has developed through Cologuard®. The company’s established CRC infrastructure
– including its Nexus platform – will help connect more people to screening and support adoption across the healthcare system.
For Freenome, the approval marks the first commercial milestone in Freenome’s Personalized Cancer Detection approach, which combines risk-based screening with test
performance optimized and tailored to specific indications, all through a single blood draw. The Company also plans to incorporate SimpleScreen CRC into its broader SimpleScreen portfolio, while continuing to advance additional single- and multi-cancer
tests, built on the same multiomics platform.
Forward-Looking Statements
Statements we make in this report 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 report 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 the Form S-4 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.
Item 9.01. Financial Statements and
Exhibits.
(d) Exhibits.
| 99.1 |
Press Release issued by Freenome, Inc., dated July 27, 2026, furnished herewith. |
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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FREENOME, INC.
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By:
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/s/ Aaron Elliott
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Name:
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Aaron Elliott
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Title:
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Chief Executive Officer
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Date: July 27, 2026
Exhibit 99.1
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FDA Approves Freenome’s SimpleScreen™ CRC
Blood-Based Screening Test; Abbott to Commercialize in the U.S.
– Approval expands colorectal cancer screening options for the up to 60 million Americans who are overdue for screening –
– Medicare coverage and American Cancer Society guidance support
broader access to blood-based colorectal cancer screening –
BRISBANE, Calif. and ABBOTT PARK, Ill. (July 27, 2026) — Freenome, Inc.
(Nasdaq: FRNM), an early cancer detection company developing blood-based screening tests, and Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved SimpleScreen™ CRC, a new blood-based screening option
for colorectal cancer (CRC) in adults 45 and older who are at average risk for the disease. Abbott will exclusively commercialize the test in the U.S. this fall, expanding its CRC screening portfolio with a new option that requires only a simple
blood draw.
Colorectal cancer is the second-leading cause of cancer-related death in the U.S., but it is highly preventable and treatable when detected early through screening. Up
to 60 million Americans remain overdue for recommended screening,1 underscoring the need for additional convenient screening approaches that can help reach more people.
“The most effective screening test is the one a person will actually complete,” said 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.2 “Many people who should be screened for colorectal cancer simply aren’t. A blood-based test provides another way to reach unscreened patients, and bringing more
people into the screening fold leads to earlier detection and better outcomes.”
SimpleScreen CRC detects signals associated with colorectal cancer from cell-free DNA (cfDNA) in the blood. FDA approval reflects years of clinical research,
AI/ML-driven technology development and extensive collaboration with investigators, healthcare providers and partners.
SimpleScreen CRC was evaluated in PREEMPT CRC, the largest prospective clinical validation study ever conducted for a blood-based colorectal cancer screening test.
Conducted at over 200 sites, PREEMPT CRC enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45 and 85 who were scheduled for a screening colonoscopy. In a prespecified analysis adjusted to match the U.S. Census,
SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions (APLs) with 13.7% sensitivity, including 30.7% for APLs with high-grade dysplasia. The test showed 90.4% specificity for advanced colorectal
neoplasia. In practical terms, the test correctly detected about 8 in 10 colorectal cancers while correctly producing negative results for 9 of 10 people without colorectal cancer or advanced precancerous lesions.
"Today's approval is an important validation of the scientific vision we've spent more than a decade building," said Aaron Elliott, Ph.D., CEO of Freenome.
"SimpleScreen CRC is the first commercial realization of our Personalized Cancer Detection strategy, built on base-level cfDNA methylation and AI enhanced accuracy. We believe this common technology foundation will power our expanding portfolio of
cancer screening tests, continuous performance improvements and future product generations as our platform continues to learn."
“The fact is that 90% of colorectal cancer deaths are preventable, yet the disease will still claim more than 55,000 lives in the U.S. this year alone,” added Anjee
Davis, MPAA, CEO of Fight Colorectal Cancer. “Regular screening is the key to reversing that trend, and new, minimally invasive screening options that help more people get screened are a critical part of that process. Colorectal cancer is
increasingly affecting younger adults, and a screening test that fits into a routine visit, accompanied by prompt follow-up in response to an abnormal result, can play an important role in driving earlier treatment and prevention.”
With FDA approval, SimpleScreen CRC meets the coverage criteria for Medicare and is expected to be incorporated into the American Cancer Society guidelines by name.
Together, these milestones help expand access to blood-based CRC screening for eligible adults.
Under the terms of the commercial agreement signed between Freenome and Abbott in August 2025, Freenome will receive a $100 million milestone payment from Abbott for
this FDA approval. Abbott will exclusively commercialize SimpleScreen CRC in the U.S., building on the provider relationships, reimbursement expertise and patient support programs it has developed through Cologuard®. The company’s established CRC
infrastructure – including its Nexus platform – will help connect more people to screening and support adoption across the healthcare system.
“FDA approval is a significant milestone in our mission to help more people get screened, detect colorectal cancer earlier and ultimately help save lives,” said Jake
Orville, senior vice president of Abbott’s cancer diagnostics business. “No single screening option will reach every patient. By adding SimpleScreen CRC alongside Cologuard, we are expanding the choices available to healthcare providers and helping
remove barriers that keep too many people from getting screened.”
For Freenome, the approval marks the first commercial milestone in Freenome’s Personalized Cancer Detection approach, which combines risk-based screening with test
performance optimized and tailored to specific indications, all through a single blood draw. The company also plans to incorporate SimpleScreen CRC into its broader SimpleScreen portfolio, while continuing to advance additional single- and
multi-cancer tests, built on the same multiomics platform.
About SimpleScreen CRC
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.
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,
with clinical validation through the PREEMPT CRC Study, and a pipeline of tests for lung cancer and additional indications is designed to increase cancer screening participation among millions of at-risk individuals. For more information, visit www.freenome.com.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. Connect with us at abbott.com and on LinkedIn, Facebook,
Instagram, X and YouTube. Learn more at www.abbott.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 the Form S-4 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. Ebner 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.
2. 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 (Freenome)
Ryan Flinn
The Grace Group
ryan@gracegroup.us
media@gracegroup.us
Media contact (Abbott)
Laura Anderson
laanderson@exactsciences.com
Investor contact
freenome@gilmartinir.com
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