The latest solution to enable comprehensive
genomic profiling of tumors will be presented at
the annual meeting of the Association of Molecular
Pathology
Customer-led research and presentations at the
conference will deliver the latest evidence and education in
tumor profiling
SAN
DIEGO, Nov. 19, 2024 /PRNewswire/ -- Illumina,
Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and
array-based technologies, today announced that it will release
TruSight™ Oncology 500 v2 (TSO 500 v2), a new
version of its flagship cancer research assay to enable
comprehensive genomic profiling (CGP). The assay is currently under
development, with global release planned for
mid-2025. Detailed plans for the product will be
shared November 21 in a spotlight presentation at the annual
meeting of the Association of Molecular Pathology (AMP) in
Vancouver, British Columbia.
TSO 500 v2 assesses hundreds of genes across all variant
classes, and immuno-oncology biomarkers, in a single assay from one
sample, to facilitate therapy selection research.
Key features of TSO 500 v2 include:
- Faster turnaround time and reduced hands-on time
- Sensitive variant calling and improved coverage of difficult
genomic regions
- Gold-standard Myriad® Genomic Instability Score
(GIS) to determine homologous recombination deficiency (HRD)
status, included for all samples
- New kit configurations with 50% less packaging, 70% fewer
tubes, and improved usability
- Automation methods available with flexible batch sizes
- Integrated and automated data analysis, from sequencer to
insights supported with DRAGEN™ secondary analysis and
Illumina Connected Insights, or Velsera's Clinical Genomics
Workspace (CGW)
- Broad platform compatibility
At AMP, several abstracts accepted for poster presentations will
demonstrate preliminary analytical performance data and automation
compatibility of TSO 500 v2. The studies support the assay's
applications for clinical research in identifying rare genetic
biomarkers and fusion biomarkers.
TSO 500 v2 early access customer response
Wei Song, MD, PhD, director of
Clinical Genomics and Molecular Pathology at the University of California, San Diego, is an early
access customer testing TSO 500 v2.
"We are excited to assess the new features of the TruSight
Oncology 500 v2 tissue assay, such as the faster workflow, improved
coverage, and lower DNA/RNA input levels," he said. "Such
improvements are highly relevant to clinical research laboratories
and can positively affect time to results, quality of results, and
the processing of challenging tissue samples."
TruSight Oncology portfolio enables clinical research and
in-vitro diagnostic CGP solutions
Illumina's oncology portfolio has evolved over time to fit
customers' diverse needs for versatility and scalability. The
TSO portfolio encompasses research-use-only (TSO 500 products) and
in-vitro diagnostic (TSO Comprehensive) solutions across a
range of low-, mid-, and high-throughput
instrumentation. Illumina also announced today that TSO
Comprehensive kits are now available to ship. In August, the
company announced FDA approval of its TSO Comprehensive test and
its first two companion diagnostic indications.
"In listening to our broad range of customers, we understand
there are different needs for biomarker profiling, and Illumina has
successfully introduced a continuum of solutions to address varying
levels of need," said Traci
Pawlowski, vice president of Clinical Solutions at
Illumina.
CGP is a critical tool for identifying actionable alterations,
including rare mutations, which enables precision medicine in
accordance with professional guidelines. At AMP, several
customer-led poster presentations will provide further evidence for
the clinical utility of CGP and demonstrate its versatility in
hospital and community oncology care settings.
Illumina will cohost a workshop with Bayer, featuring a panel
discussion of key opinion leaders on the challenges and practice
gaps in precision medicine implementation, and the coordination of
a multidisciplinary team to ensure optimal biomarker detection and
targeted therapy utilization.
For a list of Illumina workshops and presentations at AMP, visit
the company's events page.
Use of forward-looking statements
This release may contain forward-looking statements that involve
risks and uncertainties. Among the important factors to which our
business is subject 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 modifying and scaling manufacturing operations,
and reliance on third-party suppliers for critical components; (ii)
our ability to manufacture robust instrumentation and consumables;
and (iii) the acceptance by customers of our newly launched
products, which may or may not meet our and their expectations,
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
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:
Christine
Douglass
PR@illumina.com
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SOURCE Illumina, Inc.