Development, Evaluation, and Comparison of Prognostic Biomarkers in Prostate Cancer

Detección, diagnóstico y estratificación de riesgo en PCa

Graduación histológica para determinar la agresividad

Tissue-based Biomarkers for risk stratification

Tissue-based molecular biomarkers may facilitate accurate risk stratification for appropriate treatment in the clinical continuum of PCa:

• identify patients with favorable risk disease, candidates for active surveillance
• determining the optimal treatment approach for men with high-risk disease
• identifying patients for additional treatment following initial therapy

Decipher: Main points

• insurance reimbursed test included in NCCN and ASCO guideline statements
• microarray-based expression of 22 genes involved in androgen receptor signaling, cell proliferation differentiation, motility, and immune modulation
• test can be performed on either a positive biopsy specimen or a post-RP specimen
• provides percentage risk of distant metastasis in 5- and 10-years, 15-year disease specific mortality, and the risk of adverse pathology at RP
• Decipher is the most broadly validated of all the tissue-based biomarkers
• *costs: ~$4.000

Decipher: Sample report

Oncotype Dx: Main points

• mentioned in both the ASCO and NCCN guidelines
• quantitative RT-PCR assay, expression of 17 genes (12 cancer specific and 5 housekeeping genes)
• Oncotype score is combined with NCCN risk groupings on the test report to provide a comprehensive risk score
• provides a percentage risk of PCa death within 10 years, metastasis within 10 years, and risk of adverse pathology on RP
• Costs: ~$4.520

Oncotype Dx: Sample report

Oncotype Dx: Sample report

Prolaris: Main points

• is mentioned in the NCCN and ASCO guidelines
• 46 genes, comprising 31 genes involved in cell cycle progression and 15 housekeeping genes by RT-PCR
• gives the score percentile within the patient’s NCCN risk group
• also provides a percentage risk of 10-year disease specific mortality and distant metastasis
• costs: ~$3.400

Prolaris: Sample report

Prolaris: Sample report

Esquema general del trabajo

resumen datasets usados

Asignación de score

Evaluación de la firma en multiples sets de datos

Comparción de la performance de firmas

Concordance-index

Comparación de la performance de firmas

Hazard Ratio

Próximos pasos

esquema resultado extendido

datos varios

concordance index

el índice de concordancia evalúa qué tan bien un modelo de supervivencia clasifica o predice el orden de supervivencia de diferentes sujetos en un conjunto de datos

Prximas cosas a agregar

Optimizacion de firma

ver cuan pocos genes puedo usar, puedo con 8? con 7? definir controles dentro de nuestro dataset?

Fortalezas y llimitaciones

Executive Summary

• Company Overview: A cutting-edge biotech startup specializing in the development of novel genomic signatures for prostate cancer, offering advanced RNA sequencing services.
• Unique Value Proposition: A new prostate cancer signature with higher sensitivity and specificity than the traditional Gleason score, designed for effective discrimination during biopsies.
• Goals and Objectives: To revolutionize prostate cancer diagnostics/prognostics and expand into pancreatic cancer research, providing valuable tools for hospitals and pharmaceutical companies.

Market Analysis

• Industry Overview: Growing demand for personalized medicine and precision diagnostics in oncology.
• Target Market: Hospitals/Clinicians/Oncologists/Patients requiring advanced diagnostic tools, pharmaceutical companies seeking molecular profiling for drug development.
• Market Needs: Improved diagnostic tools for intermediate Gleason score prostate cancers, precision medicine approaches in oncology.
• Competitive Analysis: Presence of established biotech companies in cancer genomics; differentiation through superior sensitivity and specificity.

Products and Services

• Prostate Cancer Signature: A novel prognostic tool with higher accuracy in predicting cancer progression.
• RNA Sequencing Services: Comprehensive sequencing and bioinformatics analysis for prostate and, in the future, pancreatic cancer.
• Future Expansion Plans: Extend services to other types of cancer based on market demand and research advancements.