TEST:

TruSight Oncology 500 HRD Assay

Assays for GI assessment not only show a high concordance with each other but also in correlation with Myriad myChoice. Thus, almost all of the assays included here can be used effectively to assess HRD-associated GI in the clinical setting. This is important as PARPi treatment on the basis of these tests is compliant with European Medicines Agency approvals, which are methodologically not test-bound.

Comparison between the Illumina and Myriad assays showed that overall HRD status, the individual components of BRCA analysis, and HRD GIS detection results were highly concordant (>93%), suggesting the TSO 500 HRD assay will approach the analytical accuracy of the FDA-approved Myriad assay.

Sponsored by llumina

"We developed the Seraseq HRD reference materials to meet the needs of laboratories looking to analyze HRD in cancer patient samples. The HRD status of each material was evaluated using several assays using different measurement approaches. Although the materials showed similar trends and concordance among formats, there was variability in GIS across the methods tested."

"Illumina...and Myriad Genetics...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."

The TSO 500 HRD assay demonstrated high analytical sensitivity and specificity in detecting BRCA variants and calculating a GIS for HRD status assessment in ovarian cancer samples. TSO 500 HRD enables high-resolution comprehensive genomic profiling alongside HRD assessment to maximize biomarker detection from limited amount of sample.

"Illumina...announced the upcoming presentation of multiple oncology research abstracts at this year’s European Society of Medical Oncology (ESMO) annual meeting, September 9–13 in Paris. The abstracts underscore the value of next-generation sequencing (NGS) and Illumina’s oncology assays for cancer research and patient care."

Conclusions The TSO 500 HRD assay demonstrated high analytical sensitivity and specificity in detecting BRCA variants and GIS status for HRD status assessment in ovarian cancer samples. TSO 500 HRD enables high resolution comprehensive genomic profiling alongside HRD assessment to maximize biomarker detection from limited amount of sample.

"Illumina, Inc...announced the launch of a research test, codeveloped with Merck (known as MSD outside the United States and Canada)...The Research Use Only TruSight Oncology 500 HRD test is a next-generation sequencing (NGS)–based assay that harnesses the power of Illumina NGS technology and validated HRD technology from Myriad Genetics (NASDAQ: MYGN), enabling labs to accurately detect genomic instability and analyze more than 500 genes simultaneously, including those relevant to HRD status."