Illumina and Myriad Genetics expand partnership to broaden access to HRD testing in the United States
Strategic partnership offers a unique combination of diagnostic development and commercialization capabilities to the pharmaceutical industry
SALT LAKE CITY, March 02, 2023 (GLOBE NEWSWIRE) -- Myriad Genetic, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, and Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the expansion of a strategic partnership to broaden access to and availability of oncology homologous recombination deficiency (HRD) testing in the United States. Under the agreement, Illumina TruSight™ Oncology 500 HRD (TSO 500 HRD), a research-use-only test, is now available in the US. The expanded partnership also establishes a unique companion diagnostic (CDx) alliance for the pharmaceutical industry, which will enable more clinical research for gene-based, targeted therapies.
Expanding access to HRD research test
The TSO 500 HRD research test aligns Myriad’s gold standard MyChoice® CDx HRD technology with Illumina’s pan-cancer test, TSO 500. The test was codeveloped with Merck (known as MSD outside the US and Canada) and Myriad Genetics. Myriad and Illumina’s initial partnership led to Illumina’s combined HRD and TSO 500 offering launch worldwide—excluding the US and Japan—in June 2022.
TSO 500 HRD offers a single, comprehensive pan-cancer test to identify key genetic variants and homologous recombination deficiency critical for understanding cancer development and progression. HRD status is an important biomarker in tumors that harbor high levels of DNA damage, such as those present in ovarian, breast, prostate, and pancreatic cancers.
“Research continues to reveal the growing relevance of HRD status across multiple cancers,” said Kevin Keegan, vice president and general manager, Oncology Business Unit, at Illumina. “Now with this test, we are empowering labs in the US to unlock the most comprehensive tumor analysis from a single sample.”
“Our partnership with Illumina brings together best-in-class HRD technology and next-generation sequencing to create a comprehensive testing solution that supports the advancement of clinical research which should ultimately lead to an improvement for patients,” said Michael Lyons, general manager of Oncology, Myriad Genetics. “The availability of TSO 500 HRD in the US furthers our ability to partner with leading pharmaceutical companies and academic institutions, broadens access to clinical trials, and accelerates the pace of research and scientific innovation.”
The product is available to order now and ready to ship in the US. Illumina and Myriad are offering distributable kits and centralized laboratory service, respectively. TSO 500 customers, such as Florida Cancer Specialists & Research Institute, one of the largest independent medical oncology/hematology practices in the US, are anticipating access to the kit.
“We are excited for the opportunity to provide Illumina’s TSO 500 genomic profiling pan-cancer test with HRD assessment in a single workflow,” said Dr. Lucio N. Gordan, president and managing physician at Florida Cancer Specialists & Research Institute. “Leveraging technology from Myriad’s MyChoice CDx, our physician’s first choice among HRD tests, will help to unlock comprehensive understanding of the tumor genome and maintain laboratory efficiency. We look forward to expanding and building upon our relationships with both Illumina and Myriad Genetics.”
New CDx alliance
Under this strategic alliance, Illumina and Myriad will seek joint HRD companion diagnostics partnerships with pharmaceutical companies worldwide (excluding Japan). The joint HRD CDx alliance will aim to pursue HRD regulatory approvals for both the MyChoice HRD Assay companion diagnostic and a future clinical in vitro diagnostic test based off the TSO 500 HRD Assay.
“This CDx alliance aims to further enable clinical research for HRD testing and therapeutics, globally. Which could lead to greater access to clinical trials for precision, gene-based therapies,” said Keegan.
About TruSight Oncology 500 and TSO 500 HRD
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, it assesses key genomic signatures, such as tumor mutational burden, microsatellite instability, and HRD.
TSO 500 HRD enables researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of HRD. HRD is a genomic signature used to describe when cells are unable to effectively repair double-stranded DNA breaks. When this occurs, cells rely on alternative, error-prone DNA repair mechanisms, which may lead to genomic instability and, eventually, tumor formation. Learn more here.
About MyChoice CDx
Myriad’s MyChoice® CDx test is the most comprehensive tumor test for determining homologous recombination deficiency (HRD) status caused by a range of mutations in genes such as BRCA1 and BRCA2. It can be used to identify people with tumors that have lost the ability to repair double-strand DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as PARP inhibitors commonly used in cancer treatment. It enables healthcare professionals to identify patients with ovarian cancer who are eligible for treatment with targeted therapies.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the TSO 500 HRD research test, the anticipated benefits of such test and the CDx alliance, including that the alliance will enable more clinical research for gene-based, targeted therapies, aim to pursue HRD regulatory approvals for both the MyChoice HRD Assay companion diagnostic and a future clinical in vitro diagnostic test based off the TSO 500 HRD Assay, and seek joint HRD companion diagnostics partnerships with pharmaceutical companies worldwide (excluding Japan). These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 25, 2022, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.
Myriad, the Myriad logo and MyChoice CDx are trademarks or registered trademarks of Myriad Genetics, Inc. © 2023 Myriad Genetics, Inc. All rights reserved.
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 Twitter, Facebook, LinkedIn, Instagram, and YouTube.