COMPANY:

Illumina

"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."

"Point32Health...and GRAIL...announced the expansion of their pilot to offer GRAIL’s groundbreaking Galleri® multi-cancer early detection blood test to Harvard Pilgrim members at no cost who purchase their insurance on the Maine Health Insurance Marketplace. This expansion is the second phase of a pilot focused on collecting real-world evidence to assess the impact of the Galleri test on health care resource utilization and patient-reported outcomes."

"GRAIL, LLC...announced findings from a fundamental substudy of the Circulating Cell-free Genome Atlas (CCGA; NCT02889978) study, demonstrating that methylation had the most promising combination of cancer detection and prediction of cancer signal origin when compared with other evaluated approaches. This is the first rigorous and systematic comparison of various genomic measures from circulating cell-free DNA (cfDNA) for multi-cancer early detection (MCED) testing, and the largest comprehensive genome-wide comparison of cfDNA approaches. Findings were published online in Cancer Cell in a manuscript titled 'Evaluation of Cell-Free DNA Approaches for Multi-Cancer Early Detection.'"

"GRAIL, LLC...and Carrum Health...today announced a first-of-its-kind partnership to include the Galleri® multi-cancer early detection (MCED) test as part of Carrum Health’s oncology offering to self-insured employers. This product integration will enable employers who offer Carrum Health benefits to provide eligible employees the Galleri test as part of the comprehensive cancer care Carrum delivers."

"Henry Ford Health...and GRAIL...today announced Henry Ford Health as the first healthcare provider in Michigan to offer Galleri®, GRAIL's Multi-Cancer Early Detection (MCED) blood test. Henry Ford is among an early group of healthcare providers in the U.S. to offer this MCED test."

"John Hancock, the US division of Toronto-based Manulife...announced it is offering access to GRAIL’s Galleri® multi-cancer early detection test to a pilot group of existing customers through the John Hancock Vitality Program, in collaboration with reinsurer Munich Re Life US...Through this pilot, John Hancock will assess customer adoption of Galleri, as well as the overall user experience, before deciding how best to offer the test in the future."

"GRAIL, LLC...announced final results from the interventional PATHFINDER study, which evaluated multi-cancer early detection (MCED) screening using a blood test and the clinical care pathways following a 'cancer signal detected' MCED test result in 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer. Results were presented in a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris."

"GRAIL, LLC...announced final results from the interventional PATHFINDER study will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris. PATHFINDER data evaluating the Galleri® multi-cancer early detection (MCED) blood test will be shared in a September 11 proffered paper session."

"Illumina...announced the upcoming presentation of multiple oncology research abstracts at this year’s European Society of Medical Oncology (ESMO) annual meeting, September 9–13 in Paris. The abstracts underscore the value of next-generation sequencing (NGS) and Illumina’s oncology assays for cancer research and patient care."

"Illumina, Inc...received a decision from the European Commission prohibiting the company's acquisition of GRAIL. The company is reviewing the Commission's order and intends to appeal the decision. The EC decision follows last week's ruling by US Federal Trade Commission judge in favor of Illumina's acquisition of GRAIL....In addition, to prepare for the anticipated divestment order from the European Commission in the coming months, the company will begin reviewing strategic alternatives for GRAIL in the event the divestiture is not stayed pending Illumina's appeal....The merger of Illumina and GRAIL would usher in a transformational phase in the detection and treatment of cancer by facilitating equal and affordable access to the life-saving early cancer detection Galleri test."

"Illumina...received a favorable decision from the Administrative Law Judge (ALJ) presiding over the Federal Trade Commission's (FTC) challenge of the GRAIL acquisition. In the decision, the ALJ ruled for Illumina and rejected the FTC's position that the deal would adversely affect competition in a putative market for multi-cancer early detection (MCED) tests."

"Illumina, Inc...announced today the release of Illumina DRAGEN™ v4.0, its most accurate and comprehensive secondary analysis platform. The new features expand laboratories' abilities to perform analyses in key areas such as oncology, pharmacogenomics (PGx), single-cell sequencing, and population genomics within a single platform."

"GRAIL, LLC...announced today that the NHS-Galleri trial successfully completed enrollment in just over 10 months. The trial, which is the largest-ever study of a multi-cancer early detection (MCED) test, has enrolled 140,000 healthy volunteers aged 50-77 from select regions throughout England who have not had a cancer diagnosis or undergone treatment for cancer in the last three years."

"European Commission (EC) sent Illumina and Grail a Statement of Objections with preliminary findings alleging a breach of the so-called 'standstill obligation' of the European Union's merger regulations. The text of the regulations suggests that a merger 'shall not be implemented … until it has been declared compatible with the common market'...At the time that Illumina finalized the $8 billion deal last summer, European competition regulators were still working on a Phase II in-depth review of it."

"The European Union's General Court ruled on Wednesday that the European Commission's investigation into Illumina's purchase of Grail can continue...In an order issued Wednesday, the court dismissed a lawsuit filed by Illumina in April 2021, which challenged the investigation on jurisdictional grounds. The court also ordered Illumina to cover costs incurred by the Commission (EC)...The EC's Phase II investigation on the merits of the transaction is ongoing, though currently suspended, and the EC has launched a second investigation into Illumina's decision to forge ahead with the deal despite the review. Illumina has pledged to operate Grail independently under a 'hold separate' agreement until the investigation concludes."

"Illumina said on Thursday that it has reached a settlement and licensing agreement with China's BGI and its affiliates, including MGI Tech, that will end the multi-year legal battle between the two sequencing firms in the US...The settlement ends all outstanding litigation, including at least four lawsuits in US district courts and four pending appeals in the US Court of Appeals for the Federal Circuit, concerning patent infringement and antitrust allegations."

"Mercy and GRAIL, LLC...announced plans to offer a multi-cancer early detection (MCED) blood test. GRAIL’s Galleri® test uses advanced testing capabilities to detect early cancer signals of more than 50 types of cancer. Mercy is early among health systems to offer this first-of-its-kind test."

"Indianapolis-based Community Health Network and GRAIL, LLC...announced a partnership to offer Galleri®, GRAIL’s multi-cancer early detection (MCED) blood test, to individuals at Community Health Network’s sites of care. Community Health Network, central Indiana’s leading integrated healthcare system with more than 200 sites of care, will be the first healthcare system to offer the Galleri test to patients in its area."

"Illumina, Inc...announced the launch of a research test, codeveloped with Merck (known as MSD outside the United States and Canada)...The Research Use Only TruSight Oncology 500 HRD test is a next-generation sequencing (NGS)–based assay that harnesses the power of Illumina NGS technology and validated HRD technology from Myriad Genetics (NASDAQ: MYGN), enabling labs to accurately detect genomic instability and analyze more than 500 genes simultaneously, including those relevant to HRD status."

"GRAIL...announced today a partnership with the Westminster Fire Department (WFD) in Colorado to provide Galleri®, GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test, to WFD’s firefighters and staff. WFD, which operates six fire stations across Westminster, will be the first fire department in Colorado to offer the Galleri test to its workforce."

"GRAIL, LLC...and Fountain Health Insurance (“Fountain Health”) today announced a partnership that will offer Galleri®, GRAIL’s multi-cancer early detection (MCED) blood test, to Fountain Health customers at 100% coverage as part of its annual wellness benefits."

"GRAIL, LLC...announced today that the study design of the NHS-Galleri trial was presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The poster, titled 'NHS-Galleri Trial Design: Equitable Study Recruitment Tactics for Targeted Population-Level Screening With a Multi-Cancer Early Detection (MCED) Test,' was presented...The collaboration between GRAIL and the NHS supports the NHS Long Term Plan to transform cancer care with three in four cancers diagnosed at an early stage by 2028."

"GRAIL, LLC...and Ochsner Health...announced a multi-faceted partnership to improve cancer detection rates in Louisiana using Galleri®, GRAIL’s multi-cancer early detection (MCED) blood test. Ochsner, through a collaboration between its Ochsner Cancer Institute and Precision Medicine program, will offer the Galleri test by prescription to eligible patients in Louisiana to advance the delivery of cancer care."

"Illumina, Inc...announced the acceptance of seven key oncology research abstracts authored in collaboration with Illumina at the American Society of Clinical Oncology (ASCO) annual meeting taking place June 3 – June 7 in Chicago. In addition, Illumina will host a related event, 'Unlocking Precision Medicine: The Transformational Impact of Comprehensive Genomic Profiling'...Comprehensive genomic profiling is a next-generation sequencing (NGS) approach that uses a single test to assess hundreds of genes including relevant cancer biomarkers, as established in medical guidelines and clinical trials, for solid tumor therapy guidance."

"GRAIL, LLC...announced a broad strategic collaboration with AstraZeneca...to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage disease, with plans to embark on numerous studies across multiple indications over the next several years."

"GRAIL, LLC...announced today a collaboration with the U.S. Department of Veterans Affairs (VA) Veterans Health Administration, America’s largest integrated health care system, and the Veterans Health Foundation to provide Galleri®, GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test, to 10,000 veterans across approximately 10 participating VA sites over the next three years."

"Illumina, Inc....today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling."

"Illumina, Inc. (NASDAQ: ILMN) a global leader in DNA sequencing and array-based technologies, and Allegheny Health Network (AHN), an integrated health system serving the Western Pennsylvania area, today announced a collaboration to evaluate the impact of in-house comprehensive genomic profiling (CGP) to enhance patient care...The collaboration will also work to identify instances where blood-based testing is most beneficial, depending on cancer stages and types."

"GRAIL...and Intermountain Healthcare today announced that Galleri®, GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test, will be offered as a complement to existing single cancer screenings to help advance the delivery of cancer care through early detection. Starting this month, Intermountain will offer the Galleri test to eligible health system patients at elevated risk for cancer, such as adults over 50 years old or with additional risk factors."

"Illumina announced on Wednesday at the World CDx Summit in London that it has forged a long-term strategic collaboration with Janssen Biotech to accelerate the development of precision medicines...The collaboration aims to utilize Illumina's portfolio of resources, including AI-based genome interpretation tools, whole-genome sequencing, and multiomic analysis services, according to the company...As part of the partnership, Illumina and Janssen will codevelop CDx programs on Illumina's TruSight Oncology Comprehensive assay, a single test that assesses multiple tumor genes and biomarkers in a patient's cancer."

"Guardant Health, Inc...provided the following statement regarding a lawsuit filed by Illumina that seeks to challenge Guardant Health’s ownership and authorship of a portion of its intellectual property and to suppress competition in the market...'Illumina is using the courts to retaliate against us for registering concerns about the antitrust implications of Illumina’s acquisition of Grail – another provider of blood-based cancer tests – and in an attempt to slow us down in the marketplace as we get ready to launch our blood test to screen for early signs of colorectal cancer'."

"India's Trivitron Healthcare said on Monday that it has entered into a strategic partnership with Illumina Singapore to expand the use of next-generation sequencing-based in vitro diagnostics...Under the terms of the four-year deal, Illumina and Trivitron will develop and distribute a suite of IVD assays for oncology, infectious diseases, and prenatal health. Trivitron will manufacture and market the diagnostic tests following regulatory approvals."

"Illumina...today announced the launch of TruSight™ Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. With its global launch first taking place in Europe, the in vitro diagnostic (IVD) kit will help inform precision medicine decisions for cancer patients across the continent."

"GRAIL, LLC...announced an agreement with Point32Health, the combined organization of Harvard Pilgrim Health Care and Tufts Health Plan, to collaborate on a two-phased pilot of Galleri®, GRAIL’s groundbreaking multi-cancer early detection blood test. Point32Health is the first commercial health plan in the U.S. to work with GRAIL on its Galleri multi-cancer early detection (MCED) test as a complement to recommended cancer screenings."

"Illumina, Inc...announced an agreement with the Jean Perrin Center at the Clermont-Ferrand University Hospital in France to assess the clinical value of comprehensive genomic profiling (CGP) in cancer therapy options in patients with late-stage disease compared to use of current standard of care, including small panel tests...The Jean Perrin Center, with participation from the Toulouse Oncopole and the Bordeaux University Hospital Center, will analyze biopsy samples from patients with advanced colorectal, breast, melanoma or lung cancer using CGP enabled by Illumina's TruSight™ Oncology 500 assay."

"Illumina, Inc...and the National Cancer Center Japan have announced an international joint research project that will use Illumina's high-throughput DNA sequencing to analyse the blood-based genomic profile and clinical information of patients living with Nasopharyngeal Carcinoma. The study will be known as a part of the Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing (A-TRAIN)...The study will be conducted as part of an international collaborative study under the Asian clinical TriaLs network for cAncerS (ATLAS) project, which aims to accelerate the implementation of clinical research and to develop personalized treatments. In this study, genomic analysis of blood samples of up to 96 patients with nasopharynx cancer will be analyzed using Illumina's TruSight™ Oncology 500 ctDNA."

"GRAIL, LLC...announced a collaboration with the Knight Cancer Institute at Oregon Health & Science University (OHSU) to offer Galleri®, GRAIL’s multi-cancer early detection (MCED) blood test. OHSU will provide patients access to Galleri via a pilot program to help find signals of cancer in earlier stages and advance the delivery of cancer care."

"GRAIL, LLC...announced a collaboration with Premier, Inc.’s PINC AI™...to support patient access to Galleri®, GRAIL’s groundbreaking multi-cancer early detection blood test...Under the partnership, Premier’s PINC AI will augment its AI-enabled clinical decision support technology to alert clinicians to patients who present an elevated risk of cancer and may benefit from early detection with the Galleri test."

"Illumina, Inc...announced a multi-year partnership with Agendia N.V...The partnership is intended to advance the use of next-generation sequencing (NGS) for decentralized oncology testing and aligns with Illumina's approach to IVD partnerships in oncology...Illumina and Agendia plan to develop new tests to enhance the care and management of breast cancer patients, utilizing the Illumina MiSeq™Dx sequencing platform to expand the range of gene panels available for solid tumor analysis. We expect Agendia's flagship test, MammaPrint™, which is FDA-cleared and currently offered via Agendia's central laboratory, to be the first decentralized NGS-based breast cancer recurrence risk test cleared by the FDA."

"Illumina Inc...announced a partnership with Boehringer Ingelheim to develop companion diagnostics (CDx) for several programs in Boehringer Ingelheim's oncology pipeline. The partnership aims to accelerate the development of therapy selection and precision medicines for patients with advanced cancer...The partnership spans current and future CDx programs, with plans to add CDx claims to an in vitro diagnostic test Illumina is developing that is based on the content of TruSight™ Oncology 500 (TSO 500). The first program will co-develop a CDx for a Boehringer Ingelheim investigational medicine."