Full Press Release Details
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 .
"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."
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
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.
Investors: Brian Blanchett 858.291.6421 [email protected]
Media: Dr. Karen Birmingham EMEA: +44 7500 105665 US: 646.355.2111 [email protected]
SOURCE Illumina, Inc.