On March 2, 2023 Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, and Myriad Genetics Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported the expansion of a strategic partnership to broaden access to and availability of oncology homologous recombination deficiency (HRD) testing in the United States (Press release, Illumina, MAR 2, 2023, View Source [SID1234628092]). 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.

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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.

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; (iii) the acceptance by customers of our newly launched products, which may or may not meet our and their expectations once deployed, and (iv) our ability to obtain relevant regulatory approvals for future products, 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.