COMPANY:

Illumina

"Illumina, Inc...announced it has received approval of its divestment plan for GRAIL from the European Commission (EC)...Illumina looks forward to working with the EC on approval of final terms consistent with the divestment plan. As previously stated, Illumina has a goal of finalizing those terms by the end of the second quarter of 2024."

"Leading commercial organizations and patient advocacy groups in the field of cancer genetics...announced the founding of the Inter-Organization Cancer Genetics Clinical Evidence Coalition (INTERACT), a coalition whose mission is to increase evidence-based access to genetic testing for people with or at risk of hereditary cancers...The coalition seeks to provide a collective voice in support of the progression of medical professional and industry guidelines for genetic testing for inherited mutations that increase cancer risk."

"GRAIL, LLC...will present new data on the clinical utility of its Methylation Platform across the cancer continuum, and the impact of multi-cancer early detection (MCED) testing in guiding diagnostic evaluation at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, Calif., April 5-10, 2024....Demonstrating the first real-world evaluation of repeat MCED / Galleri testing showing the potential value of adding repeat MCED screening. The timeframe for repeat testing occurred 10-18 months from initial MCED testing. Exhibiting 4-year overall survival follow-up demonstrating the prognostic significance of detecting cancer with a methylation-based cfDNA platform like Galleri."

"GRAIL, LLC...announced today that participants from Japan, via a collaboration with AstraZeneca...will have their samples tested using GRAIL’s novel risk classification test on its Methylation Platform. This assay has been validated for recurrence risk classification in newly diagnosed Stage I lung adenocarcinoma....GRAIL’s Methylation Platform enables tissue-free, blood-based cancer detection that can be customized for a suite of precision applications across hematological and solid tumors, including risk stratification, molecular subtyping, and molecular response. This study with AstraZeneca aims to demonstrate the test’s capability to deliver results within 10 days without the need for tumor tissue, supporting use in future global pharmaceutical clinical trials."

"Getlabs...announced that it will be adding GRAIL's Galleri^Ⓡ multi-cancer early detection test to its list of test offerings. Getlabs will facilitate the sample collection process for the Galleri test by bringing the convenience of at-home blood draws to patients, eliminating the need for visits to clinics and reducing barriers to testing."

"Curative Insurance Company...and GRAIL...announced the availability of Galleri®, a multi-cancer early detection (MCED) screening test to eligible insurance plan members. The Galleri test will be available to all members, across all plan types, who are over the age of 50 and to all other members with risk factors for developing cancer. The Galleri test is part of the expansive list of benefit offerings available for $0 copay and $0 deductible* on Curative's health insurance plan."

"Delaware Chancery Court...ordered three companies controlled by activist investor Carl Icahn to remove confidential information in their lawsuit against DNA sequencing giant Illumina related to its failed $8 billion purchase of Grail."

"GRAIL, LLC...and BeniComp...announced the availability of Galleri®, a multi-cancer early detection (MCED) screening test, to eligible patients initially through BeniComp Select members. This partnership underscores BeniComp’s commitment to proactive and preventive health management, enabling an even broader reach of their transformative health insurance products."

"Devyser Diagnostics said on Monday that it has entered into an in vitro diagnostic development agreement with Illumina...The agreement will enable Sweden-based Devyser to advance its next-generation sequencing-based IVD tests on the Illumina MiSeqDx sequencer through regulatory processes in the US and in Europe. Financial and other terms were not disclosed."

"Illumina Inc...today announced it has signed an agreement with Janssen Research & Development, LLC (Janssen). This collaboration will be the first relating to the development of Illumina's novel molecular residual disease (MRD) assay, a whole-genome sequencing (WGS) multi-cancer research solution that detects circulating tumor DNA (ctDNA) to better understand the persistence or recurrence of disease following clinical intervention....The Illumina WGS MRD assay, which is currently in development, will detect ctDNA for MRD assessment in research settings that evaluate samples from patients previously diagnosed with cancer across multiple solid tumor indications."

"Illumina...announced that the company will divest GRAIL...The divestiture will be executed through a third-party sale or capital markets transaction, consistent with the European Commission's divestiture order, with the goal of finalizing the terms by the end of the second quarter of 2024."

"GRAIL, LLC...highlighted the presentation of analytical and clinical validation data on a novel prognostic test in early-stage lung cancer, generated through collaboration with the Samsung Medical Centre and AstraZeneca...The results of the studies demonstrate sensitive and specific detection of circulating tumor DNA (ctDNA) for Lung Adenocarcinoma (LUAD) at a clinically meaningful threshold for disease prognostication. This is a novel tissue-free diagnostic that has the potential to identify high-risk patients prior to surgery and/or treatment. The findings were presented in poster sessions at the North America Conference on Lung Cancer 2023 in Chicago, held Dec. 1-3, 2023."

"GRAIL, LLC...announced that it will initiate Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH/Galleri-Medicare study) following the U.S. Food and Drug Administration’s (FDA) approval of GRAIL’s Investigational Device Exemption (IDE) application and the Centers for Medicare and Medicaid Services’ (CMS) approval for Medicare coverage of the study. With age being the most significant risk factor for cancer, Medicare beneficiaries face the highest unmet need for early cancer detection."

"Veracyte...announced that it has entered into a multi-year agreement with Illumina...to develop and offer some of its high-performing molecular tests as decentralized in vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx next-generation sequencing (NGS) instrument...The first tests that Veracyte plans to develop for the Illumina NextSeq 550Dx instrument are its Prosigna Breast Cancer Assay and Percepta Nasal Swab test. Prosigna is already commercially available as an IVD test that helps inform treatment decisions for patients with early-stage breast cancer."

"Illumina Inc...announced a new generation of its distributed liquid biopsy assay for genomic profiling. The new TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2) is a research assay that enables noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood when tissue testing is not available, or to complement tissue-based testing....Expected in the first half of 2024, automation-enabled kits and method for TSO 500 ctDNA v2 will allow laboratories to scale with the growing demand for this technology."

"...Sarah Cannon Cancer Institute, part of HCA Healthcare, and GRAIL, LLC...announced a strategic collaboration to advance comprehensive cancer care through early detection...GRAIL’s Galleri® multi-cancer early detection (MCED) test will be available to patients who meet screening criteria at select HCA Healthcare physician practices."

"Illumina...has received an order from the European Commission (EC) directing the company to divest GRAIL...Receipt of the order is an important next step in evaluating divestiture options for GRAIL. Illumina is committed to resolving all issues regarding GRAIL in a timely manner, with the objective of achieving the maximum value for shareholders and the best outcome for GRAIL."

"GRAIL, LLC...announced that detailed findings from the PATHFINDER study of its multi-cancer early detection (MCED) blood test have been published in The Lancet. The study, conducted in 6,662 adults over the age of 50 without symptoms suggestive of cancer, demonstrated that an earlier version of GRAIL’s MCED test identified many cancer types that do not currently have recommended screening tests, enabled targeted cancer diagnostic evaluations, and supported diagnostic resolution for the majority of participants in less than three months."

"Point32Health...GRAIL...announced the expansion of their pilot to offer GRAIL’s groundbreaking Galleri^® multi-cancer early detection screening test. The pilot includes members meeting eligibility requirements whose primary care provider (PCP) is a Mass General Brigham affiliated provider and who are covered under a Harvard Pilgrim Health Care or Tufts Health Plan employer-sponsored plan or a Harvard Pilgrim Health Care Massachusetts Connector plan."

"Myriad Genetics, Inc...today announced two key milestones in its strategic partnership with Illumina Inc...to advance and support clinical research for gene-based, targeted therapies....Under the strategic partnership, Myriad and Illumina are working together to advance comprehensive genomic profiling plus homologous recombination deficiency (HRD) testing using the globally distributed Illumina TruSight Oncology 500 (TSO 500) assay, which enables comprehensive genomic profiling by analyzing 523 genes across DNA and RNA variants."

"Whitman-Walker Institute...Cancer Support Community (CSC)...and GRAIL, LLC...announced a research collaboration aimed at advancing health equity in cancer screening and care with GalleriⓇ, a multi-cancer early detection (MCED) test, in diverse patient populations...The Implementation and Navigation of Cancer Liquid biopsy to Understand Diverse Patient Experiences (INCLUDE) study will evaluate established community outreach strategies intended to build awareness and increase early cancer screening."

"Guardant Health, Inc...announced an agreement with Illumina Inc...that resolves their pending litigation and promotes a shared resolution to advance the companies’ long-term, commercial partnership...The companies have also extended their long-standing commercial relationship by agreeing to collaborate on the sharing of specimen samples to advance cancer research, and by entering into a new long-term purchase and supply commitment."

"Illumina Inc...and Pillar Biosciences Inc...today announced a strategic partnership to make Pillar's suite of oncology assays commercially available globally as part of the Illumina portfolio of oncology products. The agreement will result in an unprecedented offering of complementary next-generation sequencing solutions that will enhance the efficiency, accuracy, and cost-effectiveness of oncology testing through advanced sequencing techniques, improving patient access to personalized cancer treatment options....Pillar's targeted assays help oncologists and researchers identify mutations that drive tumor growth."

"The European Commission on Wednesday fined Illumina €432 million ($479 million) for acquiring liquid biopsy firm Grail prior to approval by competition regulators."

"GRAIL, LLC...and the University of Oxford...announced that results from the SYMPLIFY study have been published in The Lancet Oncology. SYMPLIFY is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented with symptoms to primary care and were referred for diagnostic follow-up for suspicion of cancer."

"GRAIL, LLC...announced data evaluating the Galleri® multi-cancer early detection (MCED) test’s ability to detect a cancer signal and predict the cancer signal origin (CSO) in asymptomatic individuals in the real-world setting...Positive Galleri results with a CSO prediction were associated with a diagnosis of invasive cancer across multiple cancer types, including stage I and II cancers. The findings were presented during a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting."

"GRAIL, LLC...announced results from a retrospective analysis of the interventional PATHFINDER study to assess whether diagnostic evaluations of individuals who received a cancer signal detected (CSD) result with the Galleri® multi-cancer early detection (MCED) test were appropriately directed by the test’s cancer signal origin (CSO) predictions. The findings demonstrated that in the majority of cases (78%), the test’s CSO-directed initial diagnostic evaluation led to a diagnostic resolution. The findings were presented during a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting."

"GRAIL, LLC...and the University of Oxford...announced results from the prospective SYMPLIFY study will be presented during an oral session on Saturday, June 3, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. SYMPLIFY is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented to primary care and were referred for diagnostic follow-up for suspicion of cancer."

"Illumina is attacking the US Federal Trade Commission's constitutionality as part of its appeal to overturn the agency's order to divest cancer testing firm Grail."

"Illumina...announced some of the latest data on the impact of comprehensive genomic profiling (CGP) for oncology patients, which will be presented at the American Society of Clinical Oncology's Annual Meeting June 2–6 in Chicago. In addition to the real-world study data, Illumina, along with study collaborators, will also present on findings that expose gaps in current standard-of-care and unmet needs for cancer patients."

"GRAIL, LLC...will present new data evaluating the use and potential of its methylation-based multi-cancer early detection (MCED) platform at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 2-6. Presentations include interim results from SYMPLIFY, the first large-scale prospective study to evaluate GRAIL’s MCED test in symptomatic patients referred for cancer suspicion, as well as Galleri® real-world clinical surveillance data and subset analyses from the PATHFINDER clinical implementation study. An evaluation of Galleri implementation using a centralized model within Mercy’s multi-state health system will also be presented."

"A U.S. appeals court on Tuesday said it will accelerate reviewing Illumina Inc's challenge to a federal agency order requiring the biotechnology company to divest cancer diagnostic test maker Grail LLC...The New Orleans-based 5th U.S. Circuit Court of Appeals issued its ruling over the objection of the Federal Trade Commission. The agency said Illumina had not shown why the appeals court needed to speed up its consideration of the antitrust dispute."

"GRAIL, LLC...presented analytical validation data on its recently launched methylation-based post-diagnosis solution to accelerate cancer research (abstract LB297). Results of the analytical study demonstrated strong analytical sensitivity, specificity and precision of the tissue-free multi-cancer post-diagnosis research solution, which leverages GRAIL’s proprietary methylation platform to evaluate cell-free DNA (cfDNA) isolated from blood."

"FirstHealth of the Carolinas, Inc...and GRAIL, LLC...announced the availability of Galleri®, a multi-cancer early detection (MCED) screening test to eligible patients initially through FirstHealth’s Concierge Medicine Clinic in Southern Pines. FirstHealth will be the first health system in North Carolina to offer the Galleri MCED test to those at an elevated risk of cancer, including those aged 50 or older, as part of its comprehensive cancer screening and care. Additional primary care clinics will offer the test in the coming months."

P=NA | N=NA | "GRAIL, LLC...presented new data from a study assessing the feasibility of a pan-hematologic malignancy classifier (pan-heme classifier) based on GRAIL’s methylation platform as a potential tumor-agnostic, plasma-based cell free DNA minimal residual disease (MRD) test....The pan-heme classifier accurately detected cancer in 92% of the 428 samples tested (98% in chronic lymphocytic leukemia; >98% in multiple myeloma; >95% in non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, follicular lymphoma and mantle cell lymphoma; and 87% in acute myeloid leukemia samples). Cancer was reproducibly detected in 89% (48 of 54) of cases where paired samples were taken prior to treatment, demonstrating high biological precision. Furthermore, serially diluted DLBCL and CLL patient plasma samples were spiked into healthy volunteer plasma samples to estimate an initial pan-heme classifier LOD of 10-3 - 10-4 methyl variant allele fraction (MVAF) with <2% false positive rate."

"GRAIL, LLC...will present new data showcasing the performance of its methylation platform to detect cancer across the early- and post-diagnosis settings at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, April 14-19, 2023."

"Illumina...announced that it will appeal the Federal Trade Commission's ('FTC') decision ordering the unwinding of Illumina's acquisition of GRAIL...Illumina intends to file a petition for review promptly with a US Court of Appeals and will seek expedited treatment of the appeal. The FTC's order to unwind the acquisition will be automatically stayed pending appeal."

"Providence...and GRAIL, LLC...today announced the expansion of their partnership to offer multi-cancer early detection screening as part of clinical care to eligible individuals across the entire Providence health system....Through the partnership, eligible patients at Providence’s 52 hospitals and 900 clinics across seven states will have access to GRAIL’s Galleri® multi-cancer early detection (MCED) test, as part of a comprehensive range of health services."

"Illumina...announced the release of Connected Insights, a new cloud-based software enabling tertiary analysis for clinical next-generation sequencing (NGS) data...Expanding on Illumina's Connected Software portfolio, Connected Insights is designed to streamline interpretation and reporting from a range of assay types, enabling labs to scale use of NGS and reduce turnaround time of clinical reporting via integration of third-party knowledge bases. The initial release will support somatic oncology applications, coinciding with the increasing use of comprehensive genomic profiling (CGP) for advanced tumors."

"Illumina...and Myriad Genetics...announced the expansion of a strategic partnership to broaden access to and availability of oncology homologous recombination deficiency (HRD) testing in the United States. Under the agreement, Illumina TruSight™ Oncology 500 HRD (TSO 500 HRD), a research-use-only test, is now available in the US. The expanded partnership also establishes a unique companion diagnostic (CDx) alliance for the pharmaceutical industry, which will enable more clinical research for gene-based, targeted therapies."

"John Hancock, a unit of Manulife (NYSE: MFC), announced it will expand access to GRAIL’s Galleri® multi-cancer early detection test to eligible life insurance customers participating in the John Hancock Vitality PLUS program, a significant milestone in John Hancock’s ongoing efforts to help customers live longer, healthier, better lives. The expanded access comes after John Hancock became the first life insurance carrier to make the breakthrough screening technology available to a pilot group of customers in September 2022."

"GRAIL, LLC...announced the availability of a state-of-the-art research use only offering for biopharmaceutical companies. The new technology solution uses GRAIL’s proprietary targeted methylation platform to analyze cell-free DNA (cfDNA) isolated from peripheral blood for cancer signal interrogation. Potential research use cases include, but are not limited to, prognosis, minimal residual disease detection, and recurrence monitoring across different cancer types in research studies."