Freenome, Inc. (Nasdaq: FRNM) news centers on blood-based cancer screening, FDA decisions, commercialization milestones, and clinical or regulatory disclosures. The company is focused on early cancer detection and has disclosed programs in colorectal cancer and lung cancer screening.
Key Freenome news topics include FDA approval of SimpleScreen™ CRC, the company’s blood-based colorectal cancer screening option for adults 45 and older who are at average risk, and FDA Breakthrough Device Designation for SimpleScreen™ Lung, its investigational lung cancer screening test. Coverage also includes how Freenome applies multiomics, methylation, proteomics, next-generation sequencing, and AI/ML-powered classifiers to cancer signal detection.
Freenome’s commercial partnerships are another important news area: Abbott holds exclusive rights to commercialize SimpleScreen CRC in the United States, and a separate agreement with Roche covers an ex-U.S. kitted version of Freenome’s multi-cancer early detection test. News may also address milestone payments, provider relationships, reimbursement support, patient support programs, and the commercial rollout of the approved colorectal cancer screening test when those topics are disclosed by the companies.
Other Freenome news categories include capital-structure disclosures, governance matters, SPAC or security-structure disclosures, clinical and regulatory updates, operating results, and financial results. For a company whose business depends on diagnostic test development, FDA status, and commercialization execution, these updates help explain how Freenome’s blood-based screening programs are progressing.
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.
Freenome (FRNM) plans to report its third-quarter 2026 financial results after the market close on November 10, 2026. The results cover the quarter ended September 30, 2026. A conference call will follow at 1:30 pm Pacific Time / 4:30 pm Eastern Time, with a live and archived webcast available on the company’s investor relations website.
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.
Freenome (Nasdaq: FRNM) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to SimpleScreen™ Lung, its investigational blood-based lung cancer screening test. The designation covers adults ages 50–80 with at least a 20 pack-year smoking history who are not currently undergoing guideline-recommended lung cancer screening.
The AI-powered multiomic test is intended to detect early signals of lung cancer from a standard blood draw and be ordered by healthcare providers. According to Freenome, the FDA Breakthrough Devices Program enables interactive communication and prioritized review during premarket submission. SimpleScreen Lung builds on the company’s methylation and next-generation sequencing platform already used in the FDA-approved SimpleScreen CRC colorectal cancer screening test.
The test combines methylation and proteomics with an AI/ML classifier to determine whether a lung cancer signal is detected. A positive result would indicate a signal that may suggest lung cancer and should be followed by low-dose CT imaging; a negative result does not rule out lung cancer. Freenome is continuing clinical evaluation, including the prospective PROACT LUNG study (NCT06122077), after reporting initial development data at the 2026 AACR Annual Meeting.
Freenome (Nasdaq: FRNM) received FDA approval for SimpleScreen™ CRC, a blood-based colorectal cancer (CRC) screening test for average-risk adults aged 45+ that uses a simple blood draw to detect CRC signals from cell-free DNA. Abbott (NYSE: ABT) will exclusively commercialize the test in the U.S. starting this fall.
In the >48,000‑participant PREEMPT CRC study, SimpleScreen CRC showed 81.1% sensitivity for CRC, 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 for up to 60 million Americans overdue for screening. Under their August 2025 commercial agreement, Freenome will receive a $100 million milestone payment from Abbott tied to this approval. Freenome plans to integrate SimpleScreen CRC into its wider SimpleScreen portfolio and Personalized Cancer Detection platform.
Freenome (Nasdaq: FRNM) announced the closing of its business combination with Perceptive Capital Solutions Corp, creating a combined company renamed Freenome that is expected to begin trading on the Nasdaq Capital Market on July 21, 2026 under ticker FRNM.
The transaction is expected to deliver approximately $310 million in gross proceeds, including about $70 million from the former PCSC trust account and a fully committed $240 million PIPE led by Perceptive Advisors and RA Capital, with participation from several other healthcare investors. According to Freenome, this capital will support its blood-based early cancer detection portfolio, AI/ML-enabled multiomics platform, and commercialization efforts, including colorectal and lung cancer programs and more than 10 additional indications. The company outlines three focus pillars: advancing its comprehensive cancer detection portfolio, enhancing its AI-enabled multiomics platform, and scaling commercial, lab and digital infrastructure, supported by partnerships with Abbott and Roche.