Illumina launches research test in collaboration with Merck to unlock deeper insights into the tumor genome

New test brings validated HRD technology from Myriad Genetics to the Illumina TruSight™ Oncology 500, a single, comprehensive pan-cancer test to identify key variants critical to cancer development and progression

SAN DIEGOJune 23, 2022 /PRNewswire/ — Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the launch of a research test co-developed with Merck (known as MSD outside the United States and Canada† The research test builds on Illumina’s commitment to enable comprehensive genomic profiling and improve research critical to the realization of precision medicine in oncology. The test adds assessment of a new genomic signature to the distributed, market-leading TruSight™ Oncology 500 assay. It will be available worldwide with the exception of: the United States and Japan and will enable researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous recombination deficiency (HRD).

Illumina, Inc.  today announced the launch of a research test co-developed with Merck.  The research test builds on Illumina's commitment to enable comprehensive genomic profiling and improve research critical to the realization of precision medicine in oncology.

Illumina, Inc. today announced the launch of a research test co-developed with Merck. The research test builds on Illumina’s commitment to enable comprehensive genomic profiling and improve research critical to the realization of precision medicine in oncology.

“HRD status has emerged as an important biomarker in tumors with high levels of DNA damage, such as ovarian, breast, prostate and pancreatic cancers,” said Phil Febbo, MD, chief medical officer at Illumina. “With one sample and one test, the TruSight Oncology 500 HRD Assay provides laboratories with comprehensive, accurate and sensitive results that can greatly enhance our understanding of the genomic nature of a tumor.”

The TruSight Oncology 500 Research-Use HRD Test is a next-generation sequencing (NGS)-based test that leverages the power of Illumina NGS technology and validated HRD technology from Myriad Genetics (NASDAQ: MYGN), enabling laboratories to accurately genomic instability and analyze more than 500 genes simultaneously, including those relevant to HRD status. HRD is a genomic signature used to describe when cells are unable to repair DNA double-strand breaks effectively. When this happens, cells rely on alternative, error-prone DNA repair mechanisms, which can lead to genomic instability and ultimately tumor formation.

The Molecular Pathology Diagnostic Unit of the Technical University of Munich participated in the TSO 500 HRD Early Access program to compare the results of Illumina’s prototype TSO 500 HRD assay with a validated reference standard from Myriad Genetics.

“Our institution is delighted with the release of TruSight Oncology 500 HRD and we are very pleased with our results from the early access program,” said Nicole Pfarr, head of the Molecular Pathology Diagnostic Unit, Technische Universität München. “We look forward to using this assay routinely in our lab for future projects. Combining HRD assessment with TruSight Oncology 500 in one workflow will unlock the most comprehensive picture of the tumor genome, while maintaining efficiencies in the lab. “

Large cohort studies demonstrate that comprehensive genomic profiling (CGP) has the potential to identify relevant genetic changes in up to 90% of samples. A single, comprehensive test to assess a wide variety of biomarkers uses fewer samples and provides faster results compared to multiple, iterative tests. As a kitted, dispensable solution, this assay helps remove barriers to internalization of CGP and HRD assays, enabling labs of all sizes to offer this powerful assay.

“We are excited to reach this first milestone with Illumina to bring to market a test for HRD assessment that will help advance clinical research and broaden access to clinical trials,” said Dr. Eric H. Rubinsenior vice president, early stage development, clinical oncology, Merck Research Laboratories.

The research test is expected to be shipped worldwide (excluding the US and Japan) in August. In addition, as part of the partnership announced in September 2021Work is underway to develop a new HRD companion diagnostic (CDx) test for the EU and the UK to help identify ovarian cancer patients with a positive HRD status.

This collaboration is an extension of Illumina’s broad portfolio of oncology partnerships with industry leaders, with the shared goal of advancing cancer diagnostics and precision medicine.

About TruSight Oncology 500

TSO 500 is a research-only pan cancer test that: Comprehensive Genomic Profiling. TSO 500 is designed to identify known and emerging tumor biomarkers in 523 genes and uses both DNA and RNA from tumor samples to identify key variants critical to cancer development and progression, such as small DNA variants, fusions and splice variants. In addition, the test assesses important immune-oncological biomarkers, such as tumor mutation burden (TMB), microsatellite instability (MSI) and homologous recombination deficiency (HRD). Comprehensive biomarker content allows labs to consolidate multiple single-gene or small-panel workflows into a single assay, saving biopsy samples and time. Click here to learn more.

Use of Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties, including the expectation of reduced costs associated with storing and managing costs of genomic data. Some of the important factors that could cause actual results to differ materially from those in forward-looking statements include: (i) challenges inherent in developing and launching new products and services; (ii) our ability to implement new products, services and applications and to expand the markets for our technology platforms; and (iii) customer acceptance of our newly launched products, which may or may not meet our and their expectations once implemented, along with other factors described 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 will be disclosed in advance. We undertake no obligation, and do not intend to, update these forward-looking statements, revise or confirm analysts’ expectations, or provide any interim reports or updates on the progress of the current quarter.

About Illumina

Illumina improves human health by unlocking the power of the genome. Our focus on innovation has made us 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. For more information, visit www.illumina.com and contact us TwitterfacebookLinkedInInstagramand YouTube

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SOURCE Illumina, Inc.

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