Illumina Inc - ILMN STOCK NEWS

The University of Notre Dame is collaborating with NASA and Illumina to monitor forest health using cutting-edge technology. The Global Ecosystem Dynamics Investigation (GEDI) sensor, mounted on the International Space Station, uses lidar to create 3D maps of forests. GEDI's data is combined with genetic sequencing from the University of Notre Dame to understand tree health at an unprecedented level. This collaboration, part of NASA's Applied Earth Observations Innovation Partnership, aims to link genetic data with remote sensing to address large-scale environmental challenges. The project utilizes GEDI's lidar, ECOSTRESS's infrared sensors, and DESIS's color patterns to detect early signs of stress and disease in trees. This innovative approach could transform ecological research and forest management.

Karina Katalina Moreno, a quality control stability scientist at Illumina, has found her American dream after a journey from Monterrey, Mexico. With a biotech engineering degree and a master's from the University of Edinburgh, Moreno joined Illumina in 2023. She's making an impact as the treasurer of iLatinx, an employee resource group, and through her work in reagent stability.

Moreno is actively involved in Hispanic Heritage Month celebrations at Illumina, promoting cultural exchange and diversity. She's also passionate about mentoring young women through initiatives like Girls Who Lead days. An avid athlete, Moreno participates in various sports and finds Illumina to be a safe and inclusive space where she can express her cultural identity freely.

Illumina is supporting a project that combines genomics with citizen science to monitor ocean health in the South-West Pacific region. The Citizens of The Sea project, led by Xavier Pochon from the Cawthron Institute, equips seafaring vessels with environmental DNA (eDNA) sample collection kits. These samples are then analyzed by Sequench laboratory in New Zealand, creating powerful datasets to understand and improve ocean health.

This initiative demonstrates Illumina's commitment to environmental stewardship and sustainable future. The project leverages Illumina's expertise in genomic sequencing to contribute to marine conservation efforts, showcasing the company's involvement in innovative environmental monitoring techniques.

Illumina (NASDAQ: ILMN) has won a significant legal victory as the European Court of Justice (ECJ) ruled that the European Commission lacked jurisdiction over Illumina's acquisition of GRAIL. This decision removes the basis for a 432 million euro fine previously imposed on Illumina. The ruling comes after Illumina's spin-off of GRAIL in June 2024, which resulted in GRAIL becoming an independent public company. Illumina now holds a 14.5% minority stake in GRAIL and will continue to support it with sequencing technology and services. Additionally, in the United States, the FTC Commissioners dismissed the case against Illumina and GRAIL on August 15, 2024, following the successful spin-off, concluding the US proceedings.

GRAIL, Inc. (Nasdaq: GRAL) has published findings on the performance of its Galleri® multi-cancer early detection (MCED) test for prostate cancer in JCO Precision Oncology. The data, from the CCGA and PATHFINDER studies, show that Galleri preferentially detects aggressive, clinically significant prostate cancers over slow-growing cases.

Key findings include:

• 93% of detected prostate cancers were intermediate or high grade
• 67% were stage III or IV
• Cancer signal of origin prediction accuracy was >90%
• No low-grade cancers were detected
• Only 4.2% of stage I and II cancers were detected

These results suggest that Galleri could be valuable in population-based screening programs without contributing to overdiagnosis of indolent prostate cancers.

Illumina (NASDAQ: ILMN) has received FDA approval for its TruSight Oncology (TSO) Comprehensive test, a 500+ gene biomarker test for solid tumors. This in vitro diagnostic (IVD) kit is the first FDA-approved, distributable comprehensive genomic profiling test with pan-cancer companion diagnostic claims. It includes two companion diagnostic (CDx) indications:

1. Identifying patients with NTRK gene fusions for treatment with Bayer's VITRAKVI (larotrectinib)
2. Detecting RET fusion-positive non-small-cell lung cancer (NSCLC) patients for treatment with Lilly's RETEVMO (selpercatinib)

The test aims to improve access to localized precision oncology and increase the chances of finding actionable biomarkers. TSO Comprehensive will begin shipping to customers this year and is reimbursable under CMS national coverage determination.

Illumina (NASDAQ: ILMN) has announced a new strategy to accelerate value creation, aiming to boost revenue growth to high single digits over the next three years. The company plans to achieve this through innovations in its core genomics portfolio, enabling transformative applications using multiomics and offering higher quality insights to customers. Illumina expects to deliver double-digit to teens non-GAAP diluted earnings per share growth from 2025-2027.

The company is also partnering with the Broad Institute of MIT and Harvard to advance single-cell sequencing, leveraging Illumina's Fluent technology. Key focus areas include reinventing the genome, unlocking deeper biology, simplifying NGS operations, and turning data into insights. Illumina aims to accelerate revenue growth while improving profitability through operational efficiencies and strategic cash flow allocation.

Illumina announced its Q2 2024 financial results, reporting core revenue of $1.09 billion, a 6% decrease year-over-year but a 3% increase from Q1 2024. GAAP operating margin was 40.5% and non-GAAP operating margin was 22.2%. GAAP diluted EPS stood at $0.41 while non-GAAP diluted EPS was $1.09. The company has adjusted its 2024 revenue guidance to a decline of 2% to 3% from 2023, but raised non-GAAP operating margin guidance to 20.5% to 21% and introduced non-GAAP diluted EPS guidance of $3.80 to $3.95.

The spin-off of GRAIL was completed on June 24, 2024. Consolidated results include a $1,466 million goodwill impairment and $420 million intangible asset impairment related to GRAIL. Consolidated revenue was $1.112 billion, with an operating loss of $1,637 million, and net loss of $1,988 million. Cash flow from operations was $80 million, with a free cash flow of $48 million.

Illumina Inc. (NASDAQ: ILMN) has expanded its oncology menu for NovaSeq™ X Series customers, launching high-throughput versions of TruSight™ Oncology 500 (TSO 500 HT) and TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2). These assays enable labs to expand oncology testing research with improved sequencing economics, faster run times, and larger batch sizes.

The TSO 500 HT on NovaSeq X Series offers increased throughput and economic improvements compared to the NovaSeq 6000 System. TSO 500 ctDNA v2 provides a faster, more sensitive liquid biopsy CGP workflow from blood samples. Key improvements include 40% faster sequencing run times, a three-day total assay turnaround time, and ambient temperature shipping for consumables.