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

Rhea-AI Summary

Illumina, a leader in DNA sequencing, announced significant research at the ASCO Annual Meeting (May 31–June 4, 2024). Key highlights include collaborations with Labcorp and Sarah Cannon Research Institute (SCRI) on comprehensive genomic profiling (CGP) and molecular residual disease (MRD) assays. Illumina presented 14 abstracts, showcasing CGP's superiority over single-gene testing (SGT) in non-small-cell lung cancer (NSCLC). MRD assay data highlighted its rapid turnaround, minimal sample needs, and high sensitivity. The research aims to enhance genomic testing accessibility in oncology, supporting precision medicine goals.

Positive

• Illumina presented 14 studies at ASCO, increasing its visibility and credibility in oncology.
• Research with Labcorp demonstrated a machine learning algorithm's efficacy in assessing MSI status from CGIP data in colorectal cancer.
• Collaborative research with SCRI showed CGP's superior performance over SGT in detecting biomarkers for NSCLC therapy, with CGP identifying all required biomarkers 71.7% of the time vs. 1.2% for SGT.
• Illumina's MRD assay exhibited fast turnaround, low input needs, and high sensitivity/specificity, promising advancements in cancer monitoring.
• Partnerships with major pharma companies and research institutes reinforce Illumina's commitment to advancing precision oncology.

Negative

• The press release did not provide specific financial data, leaving investors uncertain about direct economic impacts.
• No mention of regulatory approvals or commercialization timelines, which may affect market expectations and stock price.
• The success of the MRD assay and CGP relies on continued validation and market adoption, posing potential risks if outcomes are unfavorable.

Insights

Financial Analyst

Illumina's ongoing collaborations and research presentations at the ASCO Annual Meeting highlight significant strides in the field of oncology genomics, which could potentially impact its financial outlook. The partnership with Labcorp, especially the development of a machine learning algorithm for tumor microsatellite instability (MSI) detection, suggests promising advancements. Improved detection methods could lead to wider adoption of Illumina's technologies, ultimately driving revenue growth. Moreover, the evidence supporting Comprehensive Genomic Profiling (CGP) over Single-Gene Testing (SGT) in non-small-cell lung cancer (NSCLC) further solidifies Illumina's market position.

However, it's essential to consider the competitive landscape and the pace at which these innovations are adopted. Investors should watch for regulatory approvals, commercial partnerships and market adoption rates as these will be critical in determining the financial impact. The ongoing collaboration with major pharmaceutical companies for the development of a Molecular Residual Disease (MRD) assay indicates a potentially lucrative new product line, but it remains in development, so immediate financial benefits may be limited.

In the short term, these advancements position Illumina favorably within the genomics market. In the long term, successful commercialization and widespread adoption could significantly boost revenue and market share. Investors should look for further data on commercial uptake and any forthcoming financial guidance from Illumina.

Oncology Doctor

The research presented by Illumina at the ASCO Annual Meeting underscores the growing importance of genetic profiling in cancer treatment. The data supporting Comprehensive Genomic Profiling (CGP) over Single-Gene Testing (SGT) offers strong evidence for shifting standard care practices. For patients with non-small-cell lung cancer (NSCLC), the significant improvement in biomarker detection rates with CGP compared to SGT could lead to better-targeted therapies and improved outcomes. Clinicians should be aware of these findings as they indicate a move towards more broadly applicable and precise genomic tools in oncology.

Additionally, the development of a machine learning algorithm for MSI detection in collaboration with Labcorp highlights the potential for integrating advanced computational methods with genomic data to enhance diagnostic accuracy. This could be especially useful in cancers with high MSI prevalence, like colorectal and endometrial cancers. The analytical performance evaluation of the MRD assay also suggests potential improvements in monitoring minimal residual disease, which could help in early intervention and treatment modifications.

For oncologists, these advancements translate to more robust diagnostic tools and potentially better patient management strategies. However, integration into clinical practice will depend on data from further clinical trials and real-world applications.

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

SAN DIEGO, May 29, 2024 /PRNewswire/ -- 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.

FAQ

What key research did Illumina present at ASCO 2024?

Illumina presented 14 abstracts, including studies on comprehensive genomic profiling (CGP) and molecular residual disease (MRD) assays.

How does Illumina's CGP compare to single-gene testing (SGT) in NSCLC?

Research showed CGP identified all guideline-recommended biomarkers 71.7% of the time, compared to 1.2% for SGT.

What advancements did Illumina's MRD assay demonstrate?

Illumina's MRD assay showed fast turnaround, low input requirements, and high sensitivity and specificity.

Who are Illumina's key collaborators in the presented research?

Illumina collaborated with Labcorp, Sarah Cannon Research Institute (SCRI), Eurofins, and major pharmaceutical companies.

What is the significance of Illumina's collaboration with Labcorp?

The collaboration with Labcorp included a machine learning algorithm study for tumor microsatellite instability detection, demonstrating promising results.