TEST:

PredicineCARE™

These findings establish the feasibility, efficacy, and potential biomarker utility of a novel bladder-preserving regimen, setting the stage for a paradigm shift in MIBC management.

Longitudinal intracranial CSF cfDNA can feasibly be obtained in patients with gliomas during their disease course. Numerous questions and challenges should be answered before deploying this technique.

"Predicine, Inc....is pleased to announce the publication of a landmark study in The New England Journal of Medicine (NEJM), demonstrating the clinical utility of the PredicineCARE™ liquid biopsy assay, which enabled identification and enrollment of PIK3CA-positive patients in China. The trial targets patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer (mBC)."

Moreover, CNB decreased below the limit of quantification during treatment and increased above the limit at progression. In conclusion, longitudinal CSF cfDNA can feasibly be obtained via CSF access devices in patients with gliomas during their disease course toward evaluating candidate monitoring biomarkers.

Plasma samples were collected after first-line aromatase inhibitor (AI) therapy and before initiating second-line treatment with Fulvestrant... The PredicineCARE Ultra ctDNA NGS assay showcased a superior ability to detect low tumor fractions and low-frequency mutations in HR-positive, HER2-negative breast cancer patients, significantly outperforming standard liquid biopsy assays. This enhanced sensitivity offers substantial benefits for early identification of treatment resistance and disease progression, potentially allowing for more timely and tailored therapeutic interventions.

Among those treated with endocrine therapies, 36 were treated with AI combined with Fulvestrant... The sensitive ctDNA NGS assay effectively identified gene variations and tumor fraction levels as prognostic markers in advanced HR-positive breast cancer, demonstrating significant implications for personalized treatment.

Using the high sensitivity of the ultra-deep cfDNA assay and the low-cost ddPCR assay, the fraction of variants detectable in blood-based monitoring significantly increased, aiding therapy monitoring. Unlike personalized MRD assays, the PredicineCARE Ultraâ„¢ assay is tumor-agnostic and can detect novel mutations, crucial for drug resistance studies. The assay's longitudinal tumor fraction estimation offers higher sensitivity by tracing multiple mutations.

P1, P3 | "Urine testing identifies additional NMIBC pts who may respond to erdafitinib, which is especially valuable when the parallel tissue sample submitted does not return a result. Findings support urine testing for pt selection in the recently initiated phase 3 study (MoonRISe-1, NCT06319820)."

Plasma samples were collected after aromatase inhibitor treatment and before starting Fulvestrant... The ultra-sensitive ctDNA NGS assay outperformed standard liquid biopsy assays in detecting low-frequency mutations and those from samples with low tumor fractions in HR-positive, HER2-negative breast cancer. Its superior detection may help identify patients suitable for targeted therapies like PIK3CA and ESR1 inhibitors, improving early detection of treatment resistance and disease monitoring for more effective personalized treatment strategies.

The utDNA and uCNB analyses in this study demonstrated high sensitivity and specificity, offering promising non-invasive diagnostic options for UC. These methods also have the potential to facilitate personalized therapy, improving patient management in urothelial carcinoma.

P2; N=35 --> 0 | Recruiting --> Withdrawn

"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."