COMPANY:

Freenome

"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."

"Freenome...announced...50 hospitals and community oncology practices across the United States have joined as clinical partners for its Vallania Study. The Vallania Study focuses on the detection of multiple cancers and launched earlier this year...The Vallania Study will focus on the refinement of Freenome’s multiomics platform, which is embedded with multi-cancer signatures to look for signals from several indications."

"Freenome...announced the launch of the Sanderson Study, the company’s latest study of its multiomics platform, in combination with real-world data to detect multiple cancers...The study will encompass 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...presented findings at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting that demonstrate the clinical utility of detecting not just colorectal cancer (CRC), but also precancerous adenomas in a Medicare-aged cohort for tests that screen for CRC and multi-cancer early detection (MCED) tests that include CRC...The study findings are noteworthy because the prevalence of adenomas and asymptomatic CRC increases with age, and only 29% of those ages 65 and older are up to date on CRC screening."

"Freenome...presented findings at the Digestive Disease Week (DDW) annual meeting that compared hypothetical colorectal cancer (CRC) screening tests that detect adenomas to the minimum test performance requirements established by the Centers for Medicare and Medicaid Services (CMS) in their 2021 National Coverage Determination (NCD)."

"Freenome...together with the Morehouse School of Medicine, presented findings at the Digestive Disease Week (DDW) annual meeting showing high clinical study enrollment of Black patients using various strategies to reduce participation barriers...This research was initiated in 2021 as part of PREEMPT CRC, a study to validate a blood test to detect colorectal cancer (CRC) and advanced adenomas. Freenome and Morehouse researchers examined the enrollment rate of Black patients at Morehouse School of Medicine, a Historically Black College or University (HBCU) and study site, compared to White patients at 168 other study sites over a 7-month evaluation period."

"Cerner Corporation...Elligo Health Research® and Freenome are collaborating to enable a clinical trial through the Learning Health Network to help advance early cancer detection. Together they will be using the research-activated network of health systems, real-world data (RWD) and multiomics technology, developed by Freenome, with the goal to help accelerate early cancer detection."

"Freenome...announced the completion of enrollment for PREEMPT CRC, the company’s large, prospective study to validate its blood test for colorectal cancer (CRC) screening among average-risk adults...The test uses Freenome’s multiomics platform, which combines both tumor and non-tumor signals with machine learning to detect cancer in the earliest, most treatable stages using a standard blood draw. PREEMPT CRC builds on data demonstrating a sensitivity of 94% and a specificity of 94% for detecting early-stage (I/II) CRC, and additional data highlighting the significance of detecting adenomas."

"Freenome...present research at the American Association for Cancer Research (AACR) Annual Meeting that measures the clinical impact of detecting precancerous adenomas for tests that screen for colorectal cancer (CRC), including multi-cancer early detection (MCED) tests. The research modeled detecting adenomas and cancer (prevention and interception) or primarily cancer alone (interception) for such tests...The results demonstrated that the cancer prevention and interception scenarios resulted in outcomes 2.3 to 5.6 times more favorable than the cancer interception scenarios due to increased adenoma detection."

"Freenome...announced its co-authorship of a study with Merck KGaA, Darmstadt Germany, a leading science and technology company. The companies presented data at the American Association for Cancer Research (AACR) Annual Meeting that demonstrated the combination of multiomics profiling of plasma and computational modeling may be useful in interrogating tumor and non-tumor derived signals for patients with non-small cell lung cancer (NSCLC)....The study investigated the potential of plasma-derived cell-free DNA (cfDNA) and circulating proteins as biomarkers of disease prognosis in a cohort of treatment-naive ALK/EGFR wild type patients with late-stage non-small cell lung cancer (NSCLC)."

"Freenome...presented research at the American Society of Preventive Oncology (ASPO) annual meeting. The systematic review explores predictors of adherence among average risk adults across three decades to understand how the factors driving adherence differ over time and by specific care setting...The research examined the frequency of more than 100 predictors of adherence organized by type of factor (e.g., test, patient, provider, site and environment) across five study settings, including primary care, specialty care, integrated system, safety net (e.g., community health centers) and regional cross-sectional surveys."

"Freenome...announced the initiation of Vallania, a clinical study for the refinement and further development of its multiomics platform to detect multiple cancers. The platform uses a routine blood draw and combines both tumor and non-tumor signals with machine learning to detect cancers in the earliest, most treatable stages...The Vallania Study uses the same multiomics platform with its embedded multicancer signatures to test for several indications, including lung and pancreatic cancers, and comes on the heels of research presented last fall showing promising results in detecting pancreatic cancer."

"Freenome...presented at the American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) symposium last week. The presentation described the development of Freenome’s multiomics blood test for the detection of colorectal cancer (CRC) and advanced adenomas, and recruitment for its clinical validation study, PREEMPT CRC."

"Freenome...announced today that Roche has made an investment of $290 million, bringing Freenome’s total funding to more than $1.1 billion since the company was founded in 2014. This announcement follows Freenome’s recent Series D financing of $300 million in December...'With Roche’s investment and expertise, we’ll be able to further accelerate and augment the development of our platform to test for additional cancers and expand our real-world data programs'..."

"Freenome...announced a Series D funding of $300 million. This brings the company’s total financing to over $800 million since the company was founded in 2014...The funding will support the advancement of the company’s colorectal cancer (CRC) screening test and expansion of its multiomics platform to other cancers. Freenome’s platform uses a routine blood test to detect cancer in its earliest stages, when it is most treatable."

"Freenome...announced a partnership with Siemens Healthineers to collaborate in multiomics and radiomic breast cancer diagnostics to identify suitable markers for early breast cancer detection through blood to augment existing imaging technologies...The partnership leverages Freenome’s expertise in machine learning and multiomics to detect early cancer, utilizing epigenetic, proteomic, genomic, immunologic and other data types to maximize clinical accuracy for future screening tests. This collaboration will allow Freenome and Siemens Healthineers to share their technologies by connecting imaging and clinical data with molecular data to identify new suitable markers of breast cancer that are complementary to those identified using current imaging."

"Freenome...together with researchers from Morehouse School of Medicine, presented research earlier this week at the American College of Gastroenterology (ACG) annual meeting that demonstrates rates of enrollment in a colorectal cancer screening study of African Americans (AAs) from an HBCU is similar to Caucasian enrollment at other sites...The research examined enrollment rates at the HBCU compared to a subset of other PREEMPT CRC study sites for which similar pre-screening data were available (26 of the 180 total sites). Sociodemographic data, including income, marital status and insurance status were similar across all sites. The main difference was race. At the HBCU, participants were 80.0% AA and 9.0% Caucasian, while at other sites, the participants were 11.5% AA and 82.8% Caucasian."

"Freenome...presented new research at the American College of Gastroenterology (ACG) annual meeting that underscores their commitment to improving colorectal cancer (CRC) screening. In two separate presentations, Freenome examines the benefits and burdens of detecting and removing adenomas, and the barriers to CRC screening among different age groups."

“Oncimmune Holdings plc…announces it has signed an autoantibody profiling contract with Dana-Farber Cancer Institute…Under this agreement, Oncimmune will be utilising its proprietary biomarker discovery engine, SeroTagTM, to identify autoantibodies that can be predictive of patient response or associated with resistance to checkpoint inhibitors (‘CPIs’) and chemotherapy used in Dana-Farber led studies or therapy using atezolizumab, nivolumab, pembrolizumab, durvalumab and cisplatin-based chemotherapy. In addition, SeroTag will be used for identifying autoantibodies that can be predictive of immune-related adverse events ‘irAEs’) in response treatment. The project is scheduled to complete by the end of 2021.”

"Oncimmune Holdings plc...today announces that it has successfully agreed to acquire the intellectual property (IP) and distribution rights for the EarlyCDT® technology in the People's Republic of China (PRC) and Hong Kong (HK) from Genostics Company Limited (Genostics), allowing the Company to pursue the optimum route to market in this important territory...The Asia-specific lung panel has been used in a multi-centre study, previously announced on 10 May 2019, and which is now due to complete in China in H1 2021. Data from this study are intended to be used to support approval by the China National Medical Products Administration (NMPA) for the use of the Asia-specific lung cancer test in the PRC." "

"Oncimmune Holdings plc...today announces that it has signed a commercial contract to supply its EarlyCDT Lung blood test to NHS Norfolk & Waveney Clinical Commissioning Group ('Norfolk & Waveney'). Additionally, the Company has also signed a commercial contract to supply EarlyCDT Lung blood test into the NHS Lung Health Check Programmes in Wessex and Yorkshire as part of the iDx-LUNG evaluation programme. Following in-depth due diligence by the NHS, the Company has also been notified that The National Institute for Health and Care Excellence (NICE) has selected the EarlyCDT Lung blood test for Diagnostics Assessment Guidance...Under this commercial contract, Norfolk & Waveney will be evaluating the use of the EarlyCDT Lung blood test in a clinical setting."