Freenome's SimpleScreen Lung blood-based screening test has been granted FDA Breakthrough Device Designation. Lung cancer screening is recommended for millions of American adults, yet fewer than one in five eligible individuals receive it. Barriers range from access and logistics to awareness and cost. Low-dose computed tomography (LDCT) imaging remains the standard of care, and it's effective. But most high-risk individuals never reach it. SimpleScreen Lung is being developed to change that. By offering a non-invasive blood test, we hope to make lung cancer screening easier and more accessible - bringing unscreened, high-risk individuals into the care pathway. A simple blood draw, analyzed on our multiomics discovery platform through next-generation sequencing, proteomic analysis and AI-powered classification, can identify individuals who would benefit from LDCT follow-up. It complements the existing standard of care rather than replacing it. The breakthrough designation accelerates the development pathway with FDA and recognizes what Freenome has seen in the data: a substantial unmet need that a blood test can meaningfully address. Read the press release here: https://lnkd.in/gzYrKmiU #EarlyDetection #Freenome #Oncology
Freenome
Biotechnology Research
Brisbane, California 48,487 followers
Outpacing cancer starts with early detection
About us
Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas. We have raised more than $1.1 billion from leading investors like Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures. A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.
- Website
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https://www.freenome.com/
External link for Freenome
- Industry
- Biotechnology Research
- Company size
- 201-500 employees
- Headquarters
- Brisbane, California
- Type
- Privately Held
- Founded
- 2014
- Specialties
- molecular diagnostics, multiomics, machine learning, biotechnology, cancer screening, oncology, early cancer detection, and computational biology
Locations
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Primary
Get directions
3300 Marina Blvd
Brisbane, California 94005, US
Employees at Freenome
Updates
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The excitement and enthusiasm shown yesterday at the Nasdaq Exchange are matched by the passion and commitment we bring to our work every day to make early detection of cancer more accessible through blood-based screening. #PersonalizedCancerDetection starts here. #NasdaqListed #EarlyDetection #CancerScreening
The bell has rung! Freenome is officially #NasdaqListed — catch all the listing day excitement at MarketSite. $FRNM
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Thank you Nasdaq Exchange! What a memorable experience for the Freenome team today, ringing the opening bell. A vision years in the making, that also comes right on the heels of our first FDA approval last week for the SimpleScreen CRC blood-based screening test for colorectal cancer. Milestones achieved, and more to come as we pursue our mission of outpacing cancer with early detection. #PersonalizedCancerDetection #CancerScreening #NasdaqListed
Freenome is an early cancer detection company developing blood-based tests to detect cancer when it is most treatable. Proud to welcome you, $FRNM! #NasdaqListed
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We had the honor of ringing today's opening bell at the Nasdaq Exchange to celebrate our recent listing. Congratulations to Aaron Elliott, Riley Ennis, our executive team, our Board of Trustees and all Freenomers -- you helped make this moment possible! Outpacing cancer starts with early detection, and Freenome believes cancer screening should be simple, accessible and effective. We are developing AI-powered blood-based screening tests designed to detect cancer at its earliest, most treatable stages. #CancerScreening, #EarlyCancerDetection, #PersonalizedCancerDetection #FRNM #NasdaqListed
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We at Freenome have had quite a busy month, with lots to celebrate. In July alone, Freenome: ✔️ Received FDA approval of our first SimpleScreen test – SimpleScreen™ CRC for colorectal cancer ✔️ Became a publicly traded company with our stock trading on Nasdaq as of July 21 ✔️ Released a topline data readout of an updated version of SimpleScreen CRC, showing significant gains in detecting advanced precancerous lesions (Learn more here: https://lnkd.in/g6SBm4RY) So this week, we welcomed our employees and their families to Freenome HQ in Brisbane, CA, to celebrate summer and thank everyone for the dedication, perseverance and mission-focused energy that helped us achieve these major milestones. The milestones are meaningful, but we're equally proud of the people that made them possible. Every achievement this month represents countless hours of work from the entire team, all of whom share a singular focus: making early cancer detection accessible to everyone who needs it. Outpacing cancer starts with early detection. And we're just getting started. #EarlyDetection #CancerScreening #PersonalizedCancerDetection
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Freenome reposted this
Breaking News: The FDA has approved SimpleScreen™ CRC, Freenome’s blood-based screening test for colorectal cancer. Abbott will exclusively commercialize the test in the U.S. this fall. Colorectal cancer is one of the leading causes of cancer death in the U.S., but it is highly preventable and treatable when caught early through screening. Screening is recommended starting at age 45, yet up to 60 million eligible Americans are not up to date. SimpleScreen™ CRC lets a clinician order screening with a routine blood draw at a regular visit, making it easier to start for people who have put it off. FDA approval is based on the PREEMPT CRC clinical validation study that enrolled more than 48,000 average-risk adults. The results were published in JAMA in June 2025. In the study, SimpleScreen™ CRC 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. Read the announcement: https://lnkd.in/e-E4iKzt. #ColorectalCancer #CancerScreening #EarlyCancerDetection #PersonalizedCancerDetection
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Breaking News: The FDA has approved SimpleScreen™ CRC, Freenome’s blood-based screening test for colorectal cancer. Abbott will exclusively commercialize the test in the U.S. this fall. Colorectal cancer is one of the leading causes of cancer death in the U.S., but it is highly preventable and treatable when caught early through screening. Screening is recommended starting at age 45, yet up to 60 million eligible Americans are not up to date. SimpleScreen™ CRC lets a clinician order screening with a routine blood draw at a regular visit, making it easier to start for people who have put it off. FDA approval is based on the PREEMPT CRC clinical validation study that enrolled more than 48,000 average-risk adults. The results were published in JAMA in June 2025. In the study, SimpleScreen™ CRC 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. Read the announcement: https://lnkd.in/e-E4iKzt. #ColorectalCancer #CancerScreening #EarlyCancerDetection #PersonalizedCancerDetection
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“We believed the real advantage in cancer screening would come from learning across biological signals, products and cancer types, not a single static test.” That's what Freenome co-founder Riley Ennis said about starting Freenome more than a decade ago. That belief is what took us from an early-stage research company to the Nasdaq floor today. Every step since then — validating our multiomics platform, completing the largest study of a blood-based test for colorectal cancer (CRC), developing SimpleScreen CRC — came from testing that belief. Congratulations to the team that got us here, and to the millions of people this work is meant to reach. (Nasdaq: FRNM) #NasdaqListed #PublicCompany #Biotech #Freenome
Innovation that's changing lives just found a new home. Freenome becomes #NasdaqListed. $FRNM
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Freenome (Nasdaq: FRNM) begins trading on Nasdaq today. We are an early cancer detection company working to find cancer earlier, when it's more treatable, through a single blood draw. Freenome's Personalized Cancer Detection (PCD) approach to screening combines multiomic blood-based tests with integrated digital solutions to help providers identify eligible patients and deliver guideline-based screening for each individual based on their health profile. By linking screening results with longitudinal real-world data, PCD is designed to expand participation, inform future product generations and support more precise screening over time. Our first test – SimpleScreen CRC, now under FDA review – screens for colorectal cancer and was validated in PREEMPT CRC, a study of nearly 49,000 patients. We're extending the same platform into lung cancer and more than 10 additional indications. Becoming a public company through our business combination gives us the capital to advance our tests, strengthen our AI/ML-driven multiomics platform and generate the evidence behind future launches — all so more people can be screened, including the nearly 50 million Americans who aren't up to date on colorectal cancer screening. To our team, our partners, our investors, and the clinicians and patients who took part in our research — thank you.
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Today, Freenome enters a new chapter. We've closed our business combination with Perceptive Capital Solutions Corp. – securing more than $300 million in gross proceeds – and will begin trading on the Nasdaq under the ticker FRNM on Tuesday, July 21. That capital accelerates our mission to detect cancer earlier, when it's most treatable, through a simple blood draw. With our multiomics AI/ML-driven platform clinically validated, our CLIA-certified lab processing commercial samples, and partnerships with Abbott and Roche in place, we're focused on scaling our portfolio of Personalized Cancer Detection tests — starting with colorectal cancer and extending into lung cancer and more than 10 additional indications. We're proud of the team, Board of Directors and investors that built this and grateful to our partners and everyone who has supported us along this journey. Read the full announcement: https://lnkd.in/gaeD2WYh #ColorectalCancer #CancerScreening #EarlyCancerDetection #PersonalizedCancerDetection #Freenome