COMPANY:

Freenome

"Freenome...today announced an exclusive license agreement with Exact Sciences to advance the commercialization of its colorectal (CRC) blood-based screening test,* including the U.S. commercial rights and the underlying technology. Freenome retains the rights for its CRC blood test when it is ordered in combination with additional cancer screening tests, including for lung and more than 10 other initial cancer indications the company is pursuing...Final module for the first version of Freenome’s colorectal cancer test has been submitted to FDA; approval and commercial launch anticipated in 2026"

"Freenome...announced topline results from PREEMPT CRC, a prospective, registrational clinical study to validate its blood-based test for the early detection of colorectal cancer (CRC) among average-risk adults. In a prespecified analysis, the Freenome blood test for CRC screening demonstrated 79.2% sensitivity in detecting colorectal cancer (Stage I: 57.1%, Stage II: 100%, Stage III: 82.4%, Stage IV: 100%) with 91.5% specificity for non-advanced colorectal neoplasia. The test also showed 12.5% sensitivity in detecting advanced adenomas (AA), with a sensitivity of 29% for AAs with high-grade dysplasia, also referred to as Stage 0. All endpoints were powered at 96% or greater."

"Freenome...announced the addition of $254 million from new and existing investors. The funding enables Freenome to advance the pipeline of single-cancer and tailored multi-cancer early detection tests built on its multiomics platform....Freenome is leveraging its multiomics platform, which uses computational biology, machine learning and other technologies to develop screening tools to detect cancer in its earliest, most treatable stages. The platform is also being evaluated alongside Freenome's biopharma and diagnostic company partners to non-invasively detect minimal residual disease (MRD) augmented with biological insights derived from the multiomics platform."

"Freenome...today announced the initiation of its PROACT LUNG study and provided an update on its lung cancer research, including the ongoing Vallania study. The study is intended to validate the clinical performance of the Freenome blood test for lung cancer screening. The test combines lung cancer-specific biomarkers with cancer-common markers identified on Freenome's proprietary multiomics platform....Freenome's multiomics blood-based screening platform, research programs, and clinical studies continuously enrich insights into the molecular underpinnings and commonalities across cancer types. In turn, this knowledge is used to enhance screening capabilities."

"Walgreens and Freenome...announced a multi-year relationship to advance clinical studies of Freenome’s blood-based tests for the early detection of cancer. Walgreens will combine its national footprint, patient insights, compliant recruitment technology and local infrastructure to engage diverse patient populations in Freenome’s multi-cancer research program."

"Freenome...announced...it has acquired Oncimmune Ltd...with a commercialized CE-IVD marked EarlyCDT Lung blood test, autoantibody platform and research and development pipeline of 7+ cancer detection signatures...The acquisition of Oncimmune Ltd provides Freenome with clinical and commercial resources to complement Freenome’s frontline screening efforts."

"Freenome...announced...that the Institute for Population and Precision Health (IPPH) at the University of Chicago has joined as a study partner for its Vallania Study. The Vallania Study began enrollment in 2022 and focuses on the detection of multiple cancers...The Vallania Study is a key milestone in Freenome’s plan to expand early detection of cancer screening beyond colorectal cancer (CRC). Last year, the company completed enrollment for PREEMPT CRC, its validation study for the detection of CRC."

"Freenome...announced...that Renown Health has joined as a partner for the Sanderson Study, Freenome’s study of its multiomics platform, in combination with real-world data to detect multiple cancers...The study encompasses both traditional and real-world data to generate evidence of clinical validation for certain high- and elevated-risk populations while also refining the platform’s cancer classification and risk prediction models. In addition, the Sanderson Study will build the necessary infrastructure to bridge the gap between clinical research and day-to-day clinical impact."

"Freenome...presents a subject population analysis from PREEMPT CRC, a study for the detection of colorectal cancer (CRC) at the Western Colorectal Cancer Consortium Conference in Portland, Oregon...PREEMPT CRC is the largest prospective study for CRC using a blood-based screening test in the average-risk population and is Freenome’s clinical validation study for the use of its test."

"Oncimmune Holdings PLC on Friday said that it has collaborated with Siemens Healthineers AG, a Frankfurt-based medical technology company, in order to improve malignancy risk assessment in lung cancer....The collaboration will bring together Oncimmune's EarlyCDT Lung blood test with Siemens Healthineers' AI-Rad Companion Chest CT, an AI-powered radiology assistant that supports radiologists by performing automatic post-processing, quantifying and interpreting data....The collaboration will access data from the Early Detection of Cancer of the Lung Scotland trial, the large randomised study into the utility of EarlyCDT Lung in asymptomatic screening."

"Freenome...announced...that Pennsylvania-based Geisinger is joining as a study partner for the Sanderson Study, a study for the detection of multiple cancers that pairs multiomics with real-world data...The Sanderson Study encompasses both traditional and real-world data to generate evidence of clinical validation for certain high- and elevated-risk populations while also refining the platform’s cancer classification and risk prediction models."

"Freenome...presented research on Saturday at the American Society of Hematology (ASH) Annual Meeting in New Orleans....Freenome and ADC Therapeutics have been applying this platform to investigate biological signatures associated with response to loncastuximab tesirine (lonca), a CD-19-directed antibody drug conjugate developed by ADC Therapeutics that is indicated for the treatment of adult patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after ≥2 prior lines of therapy....The initial results are part of a larger ongoing collaboration between the companies. The findings presented at ASH show promise in identifying biomarkers associated with response to lonca and also suggested mechanisms of resistance seen in non-responders, which may inform future drug combination research."