TEST:

AVENIO Tumor Tissue CGP Kit

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.

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.

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.

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.

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.

* Product in development. For Research Use Only.

Sponsored by Roche

CGP+ in nmSGCs is associated with poor outcome and distant recurrence. The rates of AA+ provide an opportunity to evaluate matched therapies in the adjuvant setting.

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

AMP/ASCO/CAP tiers were obtained with NMP for AVENIO or PierianDx for TSO. ESCAT inclusion was determined manually.

Two commercially available CGP solutions with tertiary analysis software had differences in the detection of TMB and ESCAT biomarkers, including CNAs. These differences can be largely explained by differences in variant calling and filtering algorithms and are important considerations for any diagnostic CGP offering, raising concern of inaccurate results if not properly controlled.

Conclusions CGP tests are being utilized in precision oncology, but NGS workflows and bioinformatics pipelines can be difficult to implement. The AVENIO CGP Tumor Tissue Kit is highly reproducible across sites and operators, achieving high sequencing quality metrics and diagnostic sensitivity.

We observed a high degree of agreement between the AVENIO Kit and F1CDx for all genomic variants and the genomic signatures TMB, MSI, and gLOH. Pres. at EFLM 2022

"Roche (SIX: RO, ROG;OTCQX: RHHBY) today announced that it will be showcasing next generation diagnostics solutions that will deliver fast and accurate results to help clinicians improve patient care and help reduce the healthcare burden at the 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicines (EuroMedLab) in Munich, Germany (rescheduled dates 10 - 14 April 2022)...An evaluation of the recently launched AVENIO Tumor Tissue Comprehensive Genomic Profiling (CGP) Kit for oncology research will be presented."

This new kit provides laboratories with distributed reagents and a cloud-based analysis software, for an end-to-end in-house solution to profile 324 genes associated with solid tumors across multiple cancer types, including genomic loss of heterozygosity, microsatellite instability, and tumor mutation burden. Here, we report high reproducibility and performance across five laboratory sites using a characterized panel of FFPET samples.