TEST:

AVENIO Tumor Tissue CGP Kit

These findings provide real-world evidence of the performance of a new HRD assay (HRDsig) in ovarian carcinomas.

AVENIO CGP Assay delivers high reliability with a 93.8% initial pass rate and 99.3% after retest. Its automated, integrated approach reduces hands-on and turnaround time, and ensures precision with APA and ANA more than 99%, making it an efficient solution for genomic profiling in various settings.

The AVENIO CGP assay is an end-to-end platform for tumor genomic profiling, with proven high analytical sensitivity and specificity. Its superb performance makes it well suited for translational research, providing deep genomic analyses to accelerate cancer research.

Across several studies, the AVENIO Tumor Tissue CGP Automated Assay with sequencing analysis on NextSeq has demonstrated high sample pass rates, high variant-calling agreement compared to F1CDx, and robust performance in variant detection. The assay also maintains strong performance with a wide range of DNA sample inputs. This "Assay with NextSeq" workflow provides users the flexibility to select an NGS sequencing platform based on sample throughput needs, thus enhancing operational efficiency.

As evidence for multi-biomarker and complex genomic signatures grows in precision oncology, molecular pathology labs must evolve their sequencing capabilities with the latest innovation. The new AVENIO Tumor Tissue CGP Kit V2 demonstrates high performance and incorporates faster workflows, higher throughput, improved bioinformatics algorithms, and successful incorporation of a new HRD signature.

The AVENIO CGP Assay demonstrated high agreement with 2 established CGP tests, F1CDx and PGDx, in variant reporting, and closely aligned with F1CDx in HRDsig analysis across various tissue types. These results highlight the assay's reliability and demonstrate its utility in translational research.

Further improvement on detection of PTEN structural and copy number alterations is needed for some assays in order to maximise patient identification for capivasertib in combination with fulvestrant. These data can help clinicians make informed decisions regarding suitable diagnostic tests to determine patient eligibility for breast cancer therapies.

Thus, distinctions between different approaches may lead to inconsistent results. Complexities in calling, filtering, and interpreting variants illustrate key considerations for implementation of any high-quality CGP in the laboratory and bringing uniformity to genomic insight results.

The updated AVENIO Tumor Tissue CGP Kit V2 maintains robust performance while enabling laboratories to expand their sequencing research capabilities. * For Research Use Only.

* Product in development. For Research Use Only.

Leveraging a powerful algorithm trained on Foundation Medicine's vast pan-tumor genomic database with over 100 unique genomic features, HRDsig distinguishes itself from all other HRD scores on the market. *For Research Use Only in the US.

Sponsored by Roche