TEST:

PredicineBEACON™

Nearly all patients with BCG unresponsive CIS begin salvage therapy MRD + and have a quantifiable decline in TF with treatment. We identify genomic alterations previously reported with immune escape and actionable mutations in DNA damage repair and the FGFR3 pathway, now targetable with intravesical therapy.

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.

"Predicine, Inc...announced today that it will present data from 9 ctDNA studies at ASCO 2024, spotlighting the clinical utility of Predicine’s genomic and epigenomic liquid biopsy solutions for patient selection, disease monitoring, and drug resistance mechanism studies. The forthcoming data represents significant potential for the practical application of Predicine’s cutting-edge liquid biopsy technology in personalized cancer care, clinical trials, and Companion Diagnostic (CDx) development."

In this study, we observed no significant difference in clinical outcomes between bladder cancer patients receiving bladder preservation or surgery-based intervention. Urine and blood-based MRD tests closely correlated with clinical outcomes. Our study emphasizes the value of serial monitoring of urine/plasma-based MRD assays in informing MRD status or treatment response for patients who undergo bladder preservation or cystectomy.

Minimal residual disease can be detected using utDNA prior to rTURBT with high accuracy, making this a promising urinary biomarker. If validated, the combined approach using CNB and tf from utDNA for the detection of MRD can be used to predict patients in need of maximal resection prior to starting intravesical therapy.

"Predicine...announced today that it will present data from 15 ctDNA studies at AACR 2024, spotlighting the clinical utility of Predicine’s genomic and epigenomic liquid biopsy solutions for patient selection, disease monitoring, and disease mechanism studies."

Urinary tumor DNA holds promise for detecting MRD prior to rTURBT. Tissue informed probes with ultra-deep sequencing improve detection of MRD where other biomarkers have fallen short. CNB independently performed excellently in detecting residual disease and combining tf with CNB may further optimize test performance.

Furthermore, DNA methylation abnormality scores correlated positively with mutation-based tumor fractions (r = 0.62), with higher grade samples showing a stronger correlation (r = 0.81; n = 13) than lower grade samples (r = 0.54; n = 17).ConclusionWe demonstrate the utility of methylation patterns extracted ucfDNA samples obtained prior to reTURBT to detect and monitor NMIBC. Urinary DNA methylation patterns were highly concordant with clinical pathology status and as well as tumor fractions determined from mutation analysis.

P1 | N=498 | NCT04449874 | Sponsor: Genentech, Inc. | "Consistent with the outcomes of the prior Phase 1 clinical trial, PredicineBEACON showcased remarkable biomarker results in the Phase 1b clinical trial of Divarasib Plus Cetuximab in CRC patients. A decline in KARAS G12C variant allele frequency was associated with treatment response, observed as early as CID15 in responsive patients. Using baseline, on-treatment, and end-of-treatment plasma samples, out of the 14 patients profiled, 13 (92.9%) exhibited at least one acquired genomic alteration linked with treatment resistance. The enhanced antitumor activity observed in this study reinforces the clinical utility of liquid biopsy profiling in evaluating the Phase 1b clinical trial of combined therapy in CRC patients."

This study demonstrated the clinical utility of ctDNA MRD assay in patients with resectable HCC, as notably evident in the robust detection of MRD using plasma samples collected 7 days after surgery. Furthermore, the assessment of post-surgical MRD status provided valuable prognostic insights into both patient survival and the risk of disease relapse. ctDNA MRD status played a pivotal role as a prognostic differentiator, particularly among clinically low-risk patients.

Patients and Post-neoadjuvant plasma samples were obtained after completion of chemotherapy but before surgery from patients with stage I to III TNBC who received treatment with durvalumab concurrent with weekly nab-paclitaxel followed by dose dense doxorubicin/cyclophosphamide in a single arm neoadjuvant clinical trial (NCT02489448). PredicineBeacon MRD assay was successfully performed on 3 mL plasma samples collected using from EDTA and heparin-containing tubes. Tumor fraction correlated with residual disease, RCB score and disease recurrence.

"Predicine...announce its participation in the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain. The company will present six compelling poster studies, unveiling the future of liquid biopsy solutions...These poster presentations will shine a spotlight on Predicine’s groundbreaking liquid biopsy innovations, including PredicineBEACON™, a revolutionary solution for personalized and actionable minimal residual disease (MRD) analysis."

"Predicine, Inc...announced a new study published in The New England Journal of Medicine (NEJM), demonstrating the clinical utility of its minimal residual disease (MRD) Liquid Biopsy Assay in support of Genentech's Phase 1 Clinical Trial of Divarasib. This milestone reaffirms Predicine's position as a leader in the field of liquid biopsy diagnostics....These findings underscore the clinical utility of liquid biopsy profiling in the assessment of phase I clinical trial of Divarasib."

Besides its convenience in sample collection, urine-based genomic profiling also has the potential to capture more heterogeneity of urinary tract malignancies as compared to tissue or blood based testing alone. Urine ctDNA monitoring is a useful complementary test to support standard tissue and plasma based assays in high risk bladder and UTUC patients.

Conclusions Both tumor informed mutation based and tumor agnostic mehtylation based ctDNA approaches demonstrate clinical potential to monitor disease evolution and identify resistance prior to radiographic progression. Further study of such approaches to identify pre-radiographic molecular progression is warranted.

Our results demonstrate the feasibility of using an ultra-sensitive, baseline-informed MRD assay to detect strong correlations between MRD status and prognosis outcomes in peri-surgical plasma samples collected as early as 7 days post-surgery in resectable HCC patients. This study highlights the clinical utility of MRD testing in peri-surgical settings.

Urinary tumor DNA shows promise as a surrogate for minimal residual disease and may predict TURBT pathology for NMIBC. Genomic alterations between index and rTURBT tumors are highly concordant in papillary tumors even in the setting of upstaging, which may aid in targeted intravesical or systemic therapy selection. Larger cohorts and long-term follow up is needed to determine if utDNA can risk-stratify patients prior to rTURBT and predict long-term recurrence.

"Baseline-informed ctDNA NGS assay showed ultra-sensitive capability of MRD detection on early-stage HCC patients, with outstanding positive rate through plasma samples collected 7 days post-surgery. The MRD risk provided significant prognostic evidence for patient survival and disease relapse."

Urinary tumor DNA shows promise as a surrogate for minimal residual disease and may predict TURBT pathology for NMIBC. Genomic alterations between index and rTURBT tumors are highly concordant in papillary tumors even in the setting of upstaging, which may aid in targeted intravesical or systemic therapy selection. Larger cohorts and long-term follow up is needed to determine if utDNA can risk-stratify patients prior to rTURBT and predict long-term recurrence.

Urinary tumor DNA shows promise as a surrogate for minimal residual disease and may predict TURBT pathology for NMIBC. Genomic alterations between index and rTURBT tumors are highly concordant in papillary tumors even in the setting of upstaging, which may aid in targeted intravesical or systemic therapy selection. Larger cohorts and long-term follow up is needed to determine if utDNA can risk-stratify patients prior to rTURBT and predict long-term recurrence.

"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 In patients with KRAS G12C mutant CRC, GDC-6036 demonstrated encouraging antitumor activity and early reduction in ctDNA along with acceptable and manageable safety, and PK profile compatible with once daily dosing. Data from additional pts will be presented.

"Predicine...announced today that it will highlight the clinical utility of its full suite of genomic profiling solutions at the 2022 AACR conference being held April 8-13, 2022, in New Orleans...Key highlights include: The launch of PredicineBEACON™ a tissue-agnostic, actionable minimal residual disease (MRD) detection platform...Urine, blood, and tissue based NGS solutions that address the full continuum of cancer patient care, from early cancer detection to diagnosis and therapy selection, to therapy monitoring and MRD."

"Predicine...announced...that it will present six posters highlighting clinical utility of Predicine's full suite of liquid- and tissue-based comprehensive genomic profiling solutions at the ASCO Genitourinary Cancers Symposium being held February 17-19, 2022, in San Francisco....The posters are focused on the full spectrum of GU indications, including muscle invasive bladder cancer (MIBC), metastatic castration-resistant prostate cancer (mCRPC), renal cell carcinoma (RCC) and locally advanced and metastatic Upper Tract Urothelial Carcinomas (UTUC)."

PredicineBEACON tumor-agnostic MRD assay provides an ultra-sensitive and actionable MRD detection with high sensitivity and specificity. Assessment of MRD could potentially be leveraged, for example, to avoid overtreatment of early stage of genitourinary cancers such as non-metastatic prostate cancer, non-muscle invasive bladder cancer and muscle invasive bladder cancer.