COMPANY:

Illumina

"Illumina...today announced that it will present updates on several key innovations in whole-genome sequencing, proteomics, and single-cell technology at the American Society of Human Genetics (ASHG) Annual Meeting next week in Denver. The latest details will be presented alongside new data from key opinion leaders in next-generation sequencing (NGS), illustrating the potential impact of Illumina's emerging innovations."

"Pillar Biosciences said Wednesday that more of its OncoReveal next-generation sequencing panels will be offered by Illumina in an expansion of the companies’ existing partnership...The deal includes the OncoReveal Essential MPN, Myeloid, Multi-Cancer with CNV and Fusion panel, and BRCA1 and BRCA2 plus CNV panel, which will be available as part of validated workflows on the MiSeq i100 sequencer launched last week."

"Illumina, Inc...today unveiled its MiSeq™ i100 Series of sequencing systems, delivering unparalleled benchtop speed and simplicity to advance next-generation sequencing (NGS) for labs."

"Illumina, Inc...welcomes the European Court of Justice's (ECJ's) judgment today ruling that the European Commission did not have jurisdiction over Illumina's acquisition of GRAIL."

"Illumina, Inc...today announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications."

"Illumina Inc...today announced it has expanded its oncology menu for NovaSeq™ X Series customers. The company began offering the newly verified high-throughput version of TruSight™ Oncology 500 (TSO 500 HT), and the latest version of its distributed liquid biopsy research assay, TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2), in recent months."

"Illumina said on Wednesday that it has signed a research collaboration agreement with the National Cancer Center Singapore (NCCS) to investigate the genomics of a rare cancer in Asians... the partners will use Illumina's sequencing platforms include the NovaSeq 6000 to profile the genomes of adolescent and young adult lymphoma patients from an Asian multiethnic cohort."

"Illumina, Inc. (NASDAQ: ILMN) today announced the successful completion of the spin-off of GRAIL. This milestone follows the company's previously announced plans to divest GRAIL, and GRAIL is now a public and independent company."

"The UK National Health Service said...that it will not be accelerating the implementation of Grail's Galleri multi-cancer early detection test, following a review of data from the first year of their clinical study."

Illumina Inc...announced some of its latest research being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 31–June 4 in Chicago. Highlights include data from several studies in partnership with Labcorp...research with Sarah Cannon Research Institute (SCRI) demonstrating further evidence to support the use of comprehensive genomic profiling (CGP) over single-gene testing (SGT); and the latest data supporting the development of Illumina's molecular residual disease (MRD) assay, which is currently underway in collaboration with major pharma companies."

"Illumina, Inc...announced that it has publicly filed a Form 10 registration statement with the U.S. Securities and Exchange Commission ('SEC'), in connection with its intended divestiture of GRAIL. A version of this registration statement was submitted to the SEC last December as required."

"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."