TEST:

PredicineATLAS™

PredicineWES+ is a comprehensive assay for detecting cancer variants in blood and urine. It detects mutations across 600 cancer-related genes at a 20,000x sequencing depth, with cfDNA mutation profiles that align closely with public tissue datasets. PredicineWES+ is utilized for baseline profiling in the PredicineBEACON MRD assay and demonstrates a high correlation in TMB scores with PredicineATLAS.

POLARIS-03 is a multicenter phase II trial to evaluate the safety and efficacy of toripalimab (anti-programmed cell death 1) in refractory metastatic urothelial carcinoma (mUC)...This study demonstrates the feasibility and effectiveness of integrated longitudinal ctDNA profiling as a potential biomarker in mUC patients undergoing immunotherapy and supports further clinical evaluation of minimally invasive liquid biopsy assays for treatment stratification and therapy monitoring.

"This study compared the variation landscape between gastric and colon cancer patients, and demonstrated the technical feasibility of genome-wide copy number variations through liquid biopsy, revealing its potential clinical utility of longitudinal disease monitoring."

A bioinformatic filtration step was required to account for low VAF artefact variants. We demonstrate the feasibility and challenges of producing and using bTMB reference standards across a range of bTMB levels, and how such standards could support the calibration and validation of bTMB platforms and help harmonization between panels and laboratories.

"Predicine, Inc.,.announced...that it will present four posters at the ESMO conference being held September 9-13, 2022, in Paris, France...Predicine is delighted to present at the ESMO conference and to introduce the full suite of liquid biopsy solutions, highlighting the PredicineATLAS 600 gene assay, PredicineBEACON personalized MRD assay, PredicineCNB assay for longitudinal Copy Number Burden assessment, and PredicineEPIC methylation assay."

Conclusions This study demonstrates the effectiveness of urinary tumor DNA as a tissue surrogate for mutation profiling in MIBC at the whole-exome scale, supporting urine-based noninvasive molecular profiling in precision medicine for patients with bladder cancer. PredicineWES+ assay enables accurate detection of subclonal mutations from urine samples and enables the detection of urine-based personalized minimal residual diseases (MRD) in MIBC.

"Predicine...announced the results of a new research study that demonstrated superior performance of the PredicineATLAS™ liquid biopsy next-generation sequencing (NGS) assay compared to four other leading liquid biopsy assays for key metrics. The manuscript, 'Direct comparison of circulating tumor DNA sequencing assays with targeted large gene panels,' was released online ahead of publication in PLOS ONE."

P2 | " We collected serial blood for ctDNA testing from the 51 pts with HR+, HER2- MBC enrolled in the Alt Dose Palbo trial (NCT03007979), a single-arm phase II study of palbociclib plus letrozole or fulvestrant at 5 days on/2 days off weekly schedule as the first- or second-line ET. Our study also discovered novel candidate genes involved in cell cycle and DNA damage repair pathways in association with poor outcome. Results from this study highlight the genomic heterogeneity of HR+, HER2- MBC and provide important insights in the understanding of CDK4/6 i and ET resistance mechanisms to guide therapeutic development in pts with resistant disease."

POLARIS-03 is a multicenter phase II trial to evaluate the safety and efficacy of toripalimab (anti-PD-1) in refractory metastatic urothelial carcinoma (mUC)... This study demonstrates the feasibility and effectiveness of bTMB as a potential biomarker for mUC patients undergoing immunotherapy, and supports clinical application of PredicineATLAS liquid biopsy assay as a minimally invasive tool for treatment stratification and therapy monitoring in mUC.

Our study demonstrates a cancer type-specific pattern of copy number variation across chromosome arms. The CNV abnormality score we developed in this study can be used to distinguish healthy person from cancer patient, and monitor disease progression for longitudinal patient samples.

Prospective ctDNA analysis using the PredicineATLAS liquid biopsy assay is feasible and represents a minimally invasive approach to detecting cancer-specific genetic landscape and potentially guiding personalized therapeutic decisions in mUC patients.

High TMB is associated with immunotherapy sensitivity, with a threshold of =10 mut/Mb receiving FDA accelerated approved for pembrolizumab in a tissue agnostic setting. Plasma TMB analysis was successful in over 99% of pts with available samples. Plasma TMB =9 mut/Mb was predictive of benefit from the addition of dual immune checkpoint inhibitors (D and T) to Gem and Nab-P, with a significant interaction p-value. While only present in a subgroup of pts (4.6%), this data defines a group beyond MSI-H PDAC that may benefit from immunotherapy.

High TMB is associated with immunotherapy sensitivity, with a threshold of =10 mut/Mb receiving FDA accelerated approved for pembrolizumab in a tissue agnostic setting. Plasma TMB analysis was successful in over 99% of pts with available samples. Plasma TMB =9 mut/Mb was predictive of benefit from the addition of dual immune checkpoint inhibitors (D and T) to Gem and Nab-P, with a significant interaction p-value. While only present in a subgroup of pts (4.6%), this data defines a group beyond MSI-H PDAC that may benefit from immunotherapy.

The data highlight the importance of data filtration to account for underlying low MAFs in such cell-line derived samples and that this reference material can control for variant sensitivity though not variant specificity. bTMB reference standards reported here could support the calibration and validation of bTMB platforms and help harmonization between panels and laboratories, thus improving the accuracy of testing to aid treatment decisions in oncology.

The data highlight the importance of data filtration to account for underlying low MAFs in such cell-line derived samples and that this reference material can control for variant sensitivity though not variant specificity. bTMB reference standards reported here could support the calibration and validation of bTMB platforms and help harmonization between panels and laboratories, thus improving the accuracy of testing to aid treatment decisions in oncology.

This is a comprehensive analysis of germline mutation spectrum in a large Chinese patient cohort with breast cancer. Collectively, a substantial proportion of patients with breast cancer had hereditary risk factors. Distinct distribution of pathogenic mutations in breast cancer subtypes and differential associations between mutation status and clinical features were further observed.