Illumina drives genomic testing as standard of care in oncology through collaborative research presented at ASCO

Studies presented represent key focus areas, including building evidence for clinical utility of comprehensive genomic profiling; overcoming market access barriers, and progressing the whole-genome approach for MRD

Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today 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, a global leader of innovative and comprehensive laboratory services; 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. In total, Illumina had 14 abstracts accepted to the meeting.

"Illumina is proud of our collaborations across all areas of the oncology, research, clinical, and payer communities to produce strong evidence to further enable genomic testing for patients with cancer," said Nicole Berry , head of the Americas region at Illumina. "Through this continued commitment, we can support our customers and partners to achieve their precision oncology goals for the benefit of patients everywhere."

Illumina and Labcorp: innovation-driven research

Illumina and Labcorp share five abstracts accepted at ASCO. The organizations have a longstanding partnership working to build evidence of the clinical impact and value of comprehensive biomarker testing for patients across different cancer types, to ultimately increase community oncology physicians' access to the latest genomic testing. Among the joint abstracts accepted is a poster presentation on the development and application of a machine learning algorithm trained on multiomics biomarkers for the detection of tumor microsatellite instability (MSI), which is common in certain cancers ( Abstract 1554 ). The study analyzed samples from 1838 patients with colorectal cancer using comprehensive genomic and immune profiling (CGIP). The study findings indicate that the machine-learning-driven approach accurately assessed MSI status of colorectal cancer and endometrial adenocarcinomas using CGIP data.

"Through our partnership with Illumina, we are deploying innovative research opportunities that leverage the strengths of our respective teams," said Shakti Ramkissoon, MD, PhD, vice president, medical lead for oncology at Labcorp. "This algorithm is especially exciting as a potential tool to improve assessment of MSI status."

Greater evidence supporting CGP over SGT

Illumina continues to work with leading research institutions to validate the clinical utility and value of CGP testing. CGP is a single next-generation sequencing assay that assesses hundreds of genes, including relevant cancer biomarkers, for therapy guidance. This year, a real-world analysis done with SCRI will present data demonstrating the performance of CGP versus SGT in guideline-recommended biomarker selection in non-small-cell lung cancer (NSCLC) ( Abstract 8640 ).

"The findings showed that patients with stage IV NSCLC who underwent SGT received results for all nine guideline-recommended biomarkers only 1.2% of the time, as compared to 71.7% of the time for patients tested with CGP testing," said Vivek Subbiah , MD, chief, Early-Phase Drug Development at SCRI. "Our findings clearly indicate that relying solely on single-gene testing or hot-spot testing leads to incomplete biomarker testing, which can compromise targeted therapy treatments for patients with NSCLC. To ensure optimal patient outcomes, it is imperative that we transition to comprehensive next-generation sequencing as the standard of care for NSCLC."

This work builds on evidence presented by Illumina and its collaborators at ASCO 2023, including a study with Labcorp that demonstrated that the initial use of SGT increases subsequent CGP test cancellations, and concluded that SGT practice in the community oncology setting does not meet practice guideline recommendations and negatively impacts the potential benefit of subsequent CGP for NSCLC patients (2023 Abstract 6506).

Data shows progress on MRD assay

At ASCO 2024, Illumina will present an analytical performance evaluation of its MRD assay, highlighting its fast turnaround time, low input requirements, and high sensitivity and specificity over existing market options ( Abstract 3060 ) . Earlier this year, Illumina announced collaborations with pharmaceutical companies to innovate on its MRD research assay, which is currently under development on a whole-genome backbone.

"We're committed to delivering impactful research to help enable genomic testing in oncology care," said Pratheesh Sathyan , head of Oncology for the Americas region at Illumina. "The work being presented at ASCO this year, which includes research conducted with Eurofins, Labcorp, and SCRI, will help advance access to precision oncology solutions for patients."

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X , Facebook , LinkedIn , Instagram , TikTok , and YouTube

Contacts

Investors:
Salli Schwartz
858-291-6421
IR@illumina.com

Media:
Samantha Beal
PR@illumina.com

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SOURCE Illumina, Inc.

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Illumina Inc.ILMN:US NASDAQ:ILMN:US

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Illumina launches latest chemistry across most popular mid-throughput sequencers, enabling higher quality and greater speed for customers at lower cost

Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, announced that it has completed integration of its latest chemistry, XLEAP-SBS ™ into all reagents for its NextSeq ™ 1000 and NextSeq 2000 next-generation sequencing (NGS) instruments.

"We are excited to deliver for our NextSeq 1000/2000 customers improved sequencing with faster run times, better quality, and higher output—all at lower cost per kit," said Jason Johnson , head of Global Product Management at Illumina. "XLEAP-SBS chemistry on NextSeq 1000/2000 will enable labs to perform bigger NGS projects without raising the budget, and facilitate greater adoption of multiomic approaches."

In March, the company launched its P4 flow cell (highest output of 540 Gb) with XLEAP-SBS chemistry for the NextSeq 2000, and today it announced that the XLEAP-SBS P1, P2, and P3 flow cells are all now available. XLEAP-SBS chemistry is a faster, higher quality, and more robust sequencing-by-synthesis chemistry that delivers approximately 20% faster turnaround times.

Early-access customers have shared positive feedback on improved quality, stability, and run times. Marc Monot , PhD, head of Biomics at the Institut Pasteur, said, "We were very happy with the quantity and quality of the reads. The Q is very close to Q40 and the stability is a game changer for Illumina. From the first base to the last base, [Illumina] improved the quality of the run quite a lot."

The NextSeq 1000 and NextSeq 2000 Systems are flexible and scalable mid-throughout sequencers that enable a range of applications, including single-cell, whole-exome, and RNA sequencing.

Use of forward-looking statements

This release contains forward-looking statements that involve risks and uncertainties, including the expectation for lower costs related to the storing and managing of genomic data costs. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing and launching new products and services, including meeting manufacturing, quality, and performance requirements; (ii) our ability to deploy new products, services, and applications, and to expand the markets for our technology platforms; and (iii) the acceptance by customers of our newly launched products, which may or may not meet our and their expectations once deployed, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Illumina

Contacts

Investors:
Salli Schwartz
858-291-6421
IR@illumina.com

Media:
Samantha Beal
PR@illumina.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/illumina-launches-latest-chemistry-across-most-popular-mid-throughput-sequencers-enabling-higher-quality-and-greater-speed-for-customers-at-lower-cost-302162971.html

SOURCE Illumina, Inc.

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Illumina Board of Directors approves spin-off of GRAIL; declares spin-off dividend of GRAIL shares

"When-issued" trading expected to begin on or about June 12, 2024
Record date for distribution of GRAIL shares will be June 13, 2024
Distribution date for GRAIL shares anticipated to be June 24, 2024

Illumina, Inc. (NASDAQ: ILMN) today announced that its Board of Directors has approved the spin-off of GRAIL. GRAIL is anticipated to spin off from Illumina on June 24, 2024 and has applied to list on Nasdaq as "GRAL."

"Today's announcement marks a milestone for Illumina and signals an important step forward for the company, since the divestiture of GRAIL is one of our 2024 priorities," said Jacob Thaysen , CEO of Illumina. "As we prepare to lead the next era of genomics innovation, we believe GRAIL will play an important role in advancing the industry and improving human health. We will maintain a minority share of 14.5% in GRAIL and remain excited about GRAIL's breakthroughs in the fight against cancer. We also look forward to exploring opportunities where we can support GRAIL's work with industry-leading technologies and solutions."

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Illumina appoints Everett Cunningham Chief Commercial Officer

Cunningham previously served as CCO for Exact Sciences and brings more than 20 years of commercial leadership across healthcare tech, life sciences, and pharma

- Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the appointment of Everett Cunningham as Chief Commercial Officer (CCO), effective June 10.

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Illumina releases 2023 Corporate Social Responsibility Report

Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today published its fifth annual Corporate Social Responsibility (CSR) Report. The report highlights the company's ongoing commitments and progress made in 2023 toward advancing human health by serving as a champion for patients, communities, employees, and the planet.

"At Illumina, we are guided by our mission to improve human health by unlocking the power of the genome," said Jacob Thaysen , CEO of Illumina. "Our customers, partners, and employees continue taking bold, meaningful steps to accelerate access to genomics, empower our communities, integrate environmental sustainability into our business strategy, nurture our people, and operate responsibly."

Illumina's CSR program is rooted in four key focus areas, and the company's 2023 CSR Report demonstrates progress in each:

Accelerating access to genomics : Illumina continues to bring the benefits of genomics to more people by driving down the cost of sequencing, expanding into new markets, and increasing the diversity of genomic data. In 2023, Illumina trained more than 27,000 health care professionals and continued its advocacy for health care coverage for genomic testing, which increased from 1.2 billion to 1.3 billion. The company also launched several new products, including the NovaSeq™ X Series, powered by XLEAP-SBS™ chemistry; the TruSight™ Oncology 500 ctDNA v2 research assay, enabling comprehensive genomic profiling from liquid biopsy samples; and the 25B flow cell, which can generate tens of thousands of whole genomes per year at the lowest cost per sample of any Illumina platform.
Nurturing our people and communities : In 2023, Illumina maintained a zero net pay gap for the fifth consecutive year and reached 45% female representation in the workforce, with a 5% increase in female leadership roles over the last three years. Illumina also strives to create a purpose-driven culture, and in 2023, nearly 60% of employees worldwide participated in charitable giving and volunteering.
Integrating environmental stewardship : As the genomics industry leader, Illumina plays a crucial role in contributing to a healthier planet. The Illumina NovaSeq X Series, which debuted in 2023, uses significantly more sustainable reagents, resulting in 90% less packaging weight and waste, 50% less plastic, and a 61% reduction in climate change impact. Additionally, 100% of Illumina's global electricity consumption came from renewable sources for the second consecutive year.
Operating responsibly : In 2023, Illumina strengthened its dedication to ethical business practices and operational integrity by ensuring that 100% of its core facilities participated in third-party audit programs. Illumina also expanded its ISO data privacy certification to include additional products and completed the EU-US and Swiss-US Data Privacy Framework (DPF) Self-Certification and ISO 27701 certification. Additionally, Illumina continues to exercise strong corporate governance with an independent Board of Directors (all independent with the exception of the CEO), an independent Board Chair, and 75% of standing committees chaired by women.

The full report is available on Illumina's CSR website .

Forward-Looking Statements

This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding mandates, the future, business plans and other statements that are not historical in nature. These statements are made on the basis of Illumina's views and assumptions regarding future events and business performance and plans as of the time the statements are made. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Illumina does not undertake any obligation to update these statements unless required by applicable laws or regulations, and you should not place undue reliance on forward-looking statements. Specific factors are set forth in Illumina's Annual Report on Form 10-K for the year ended January 1, 2023 under the caption "Risk Factors", in information disclosed in public conference calls, the date and time of which are released beforehand, and in filings with the Securities and Exchange Commission including, among others, quarterly reports on Form 10-Q.

About Illumina

Contacts

Investors:
Salli Schwartz
858-291-6421
IR@illumina.com

Media:
Samantha Beal
PR@illumina.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/illumina-releases-2023-corporate-social-responsibility-report-302157056.html

SOURCE Illumina, Inc.

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Anna Richo joins Illumina's Board of Directors

Ms. Richo brings more than 30 years of global legal, compliance, and regulatory experience to Illumina's Board

Illumina, Inc. (NASDAQ: ILMN) announced today that Anna Richo has joined the company's Board of Directors following shareholder approval of the director slate at the company's May 16, 2024 annual meeting. Ms. Richo currently serves as Corporate Senior Vice President, Strategic Advisor to the General Counsel and CEO at Cargill, Inc. a global food production and agricultural company.