Myriad Genetics Announces Incorporation of its Proprietary HRD platform in Illumina’s Updated Comprehensive Gene Panel Assay, TruSight™ Oncology 500 v2

Rhea-AI Summary

Myriad Genetics (NASDAQ: MYGN) announced an expanded agreement with Illumina to incorporate its Genomic Instability Score (GIS) for Homologous Recombination Deficiency (HRD) into Illumina's updated TruSight™ Oncology 500 v2 assay. Previously available only as a separate product, GIS will now be reported for all samples analyzed with TSO 500 v2, enabling comprehensive genomic profiling across multiple cancer types. This integration aims to broaden clinical research opportunities and potentially drive companion diagnostic development for HRD-based therapies beyond ovarian cancer.

Positive

• Integration of GIS into TSO 500 v2 expands market reach and application across multiple tumor types
• Potential expansion of companion diagnostic development beyond ovarian cancer
• Strengthening of oncology product portfolio through broader GIS availability

Negative

• None.

Insights

Biotech Industry Analyst

The expanded agreement with Illumina marks a significant strategic advancement for Myriad Genetics' HRD testing platform. Integration into Illumina's TSO 500 v2 assay substantially expands the market reach and clinical utility of Myriad's GIS technology beyond its current focus in ovarian cancer. This positions Myriad to capture value across a broader range of tumor types and potentially develop new companion diagnostics.

The commercial implications are noteworthy - by bundling GIS with TSO 500 v2 instead of offering it separately, Myriad gains exposure to Illumina's extensive global customer base. This could drive higher test volumes and create new revenue streams through companion diagnostic development partnerships. The move also strengthens Myriad's competitive position in the growing precision oncology market, where comprehensive genomic profiling is becoming increasingly important for treatment decisions.

Agreement will expand worldwide access and better position Myriad’s GIS as a potential companion diagnostic across multiple potential tumor types

SALT LAKE CITY, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, announced updates to its agreement with Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies.

Myriad’s gold-standard Genomic Instability Score (GIS) to determine Homologous Recombination Deficiency (HRD) will be reported for all samples analyzed with Illumina’s updated research assay, TruSight™ Oncology 500 v2 (TSO 500 v2). Previously, GIS to determine HRD was only available as a separate product. As a result, a broad array of cancer types will receive GIS results and their HRD status.

“We are pleased to expand our collaboration with Illumina and combine the two companies’ technologies to create what we believe is the most advanced and complete gene panel to enable comprehensive genomic profiling,” said Patrick Burke, PhD, EVP of Strategy and Innovation, Myriad Genetics.

Combining Myriad’s HRD technology, which is used in MyChoice^® CDx tumor-based test, with Illumina’s expertise in comprehensive genomic profiling will enable Myriad to broaden clinical research opportunities and potentially drive CDx development for HRD-based therapies across multiple potential tumor types. Broad availability of data and the Myriad GIS platform may help drive disease-site indication expansion and potential companion diagnostic product development beyond ovarian cancer.

“Inclusion of GIS in all Myriad’s Precise Tumor^® clinical reports will strengthen the company’s oncology product portfolio,” said Burke. “Precise Tumor is a pan-cancer solid tumor comprehensive genomic profiling test, leveraging Illumina’s current TSO 500 technology.”

Myriad announced the strategic partnership with Illumina in January 2021 and has expanded its relationship both geographically and technologically since that time.

About Myriad’s MyChoice CDx HRD Companion Diagnostic Test
Myriad’s MyChoice CDx is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The MyChoice test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions).

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.

Safe Harbor Statement   
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including that the company’s Genomic Instability Score (GIS) will be reported for all samples analyzed with TSO 500 v2, a broader array of cancer types will receive GIS results and their HRD status, the company’s agreement with Illumina will expand world-wide access to the company’s technology and better position the company’s GIS as a potential companion diagnostic across multiple potential tumor types, combining the company’s HRD technology with Illumina’s expertise in comprehensive genomic profiling will enable the company to broaden clinical research opportunities and potentially drive CDx development for HRD-based therapies across multiple potential tumor types, broad availability of data and the company’s GIS platform may help drive disease-site indication expansion and potential companion diagnostic product development beyond ovarian cancer, and the inclusion of GIS in all Myriad’s Precise Tumor clinical reports will strengthen the company’s oncology product portfolio. 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 28, 2024, 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. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law. 

Investor Contact 
Matt Scalo 
(801) 584-3532 
IR@myriad.com 

Media Contact 
Glenn Farrell 
(385) 318-3718 
PR@myriad.com  

FAQ

What is the new partnership between Myriad Genetics (MYGN) and Illumina for TSO 500 v2?

Myriad Genetics' Genomic Instability Score (GIS) for HRD testing will be incorporated into Illumina's TruSight Oncology 500 v2 assay, making it available for all analyzed samples instead of being a separate product.

How will the TSO 500 v2 integration affect Myriad Genetics' (MYGN) market reach?

The integration will expand worldwide access to Myriad's GIS technology and position it as a potential companion diagnostic across multiple tumor types beyond ovarian cancer.

What is the significance of GIS integration for Myriad Genetics' (MYGN) product portfolio?

The inclusion of GIS in all Precise Tumor clinical reports will strengthen Myriad's oncology product portfolio and enhance its comprehensive genomic profiling capabilities.