Illumina Partners with Merck to Develop and Commercialize Companion Diagnostic and Research Tests for Use in Identifying Specific Cancer Mutations

SAN DIEGO, Sept. 7, 2021 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN) and Merck (known as MSD outside the United States and Canada) today announced a partnership to develop and commercialize tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD). Patients whose tumors are HRD-positive may be eligible for targeted treatment by a class of precision medicines called PARP inhibitors. The HRD tests will leverage Illumina's TruSight™ Oncology 500 (TSO 500) content, enabling the most comprehensive genomic profiling assays in a single workflow.

This strategic partnership builds on an initial study conducted with Merck and leverages Illumina's relationship with Myriad Genetics (NASDAQ: MYGN) to expand international access to the proprietary technology in Myriad's FDA approved myChoice® CDx companion diagnostic test. Illumina will develop a new HRD CDx test for the EU and the UK to aid in the identification of ovarian cancer patients with positive HRD status who are eligible for treatment with LYNPARZA® (olaparib), a first-in-class PARP inhibitor, jointly developed and commercialized by Merck and AstraZeneca.

In addition, Illumina will develop and commercialize a research use only (RUO) HRD assay that will be add-on content for the TSO 500 RUO panel. Illumina plans to launch this product globally, excluding the United States and Japan.

"With such great advances in precision medicine being made by companies such as Merck, it's essential that patients who would benefit from LYNPARZA are identified," said Joydeep Goswami, Chief Strategy and Corporate Development Officer of Illumina. "By leveraging our comprehensive genomic profiling family of products, TruSight™ Oncology, and the gold standard myChoice® HRD technology, Illumina aims to offer the best-in-class HRD assay that is broadly accessible. By harnessing the incredible medicines development expertise of Merck, together we will be able to leverage the use of precision medicines to make a real difference for patients."

"HRD testing should be an essential component of clinical diagnosis as half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumors," said Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories. "Biomarker testing has rapidly enhanced our understanding of how PARP inhibition can help target a devastating disease, like ovarian cancer and we are excited to partner with Illumina on the development of a distributed CDx HRD assay for the EU and UK."

This collaboration with Merck expands on Illumina's solid history and broad portfolio of oncology partnerships with industry leaders, with the united goal of advancing cancer diagnostics and precision medicine.

About TruSight Oncology 500

TSO 500 is a Research Use Only pan-cancer assay that enables Comprehensive Genomic Profiling. Designed to identify known and emerging tumor biomarkers across 523 genes, TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. In addition, the assay assesses key immune-oncology biomarkers, such as Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI). Due to its comprehensive biomarker content, labs can consolidate multiple single gene or small panel workflows into a single assay, saving biopsy specimen and time. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic (IVD) test to the TSO product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500. To learn more about TSO 500, click here.

About Myriad Genetics and myChoice® CDx

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to improving health and well being for all.  Myriad's myChoice CDx companion diagnostic test is the first and only FDA-approved tumor test that determines homologous recombination deficiency status by detecting BRCA1 and BRCA2 (sequencing and large rearrangement) variants and assessing genomic instability using three critical biomarkers: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions. It has been referred to as "The most comprehensive Tumor test to determine HRD status in patients with ovarian cancer." To learn more about myChoice CDx, visit https://myriad-oncology.com/mychoice-cdx/.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the 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 www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

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; (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.

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SOURCE Illumina, Inc.

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