Diagnostic Development Services for Colorectal Cancer

Colorectal cancer (CRC) remains a leading cause of cancer mortality worldwide, with late-stage diagnosis and therapy resistance driving poor outcomes. At Alfa Cytology, we recognize that breakthroughs in CRC care demand more than innovative therapies—they require equally advanced diagnostics to guide patient stratification, monitor treatment response, and detect recurrence. Our end-to-end diagnostic development services empower biopharmaceutical companies and research institutions to bridge the gap between discovery and clinical impact, delivering tools that unlock the full potential of precision medicine.

Our Capabilities

Despite advancements in targeted therapies and immunotherapies, nearly 50% of CRC patients still present with metastatic disease at diagnosis. Even among early-stage patients, up to 30% experience recurrence due to undetected minimal residual disease (MRD). The limitations of traditional diagnostics—invasive biopsies, delayed results, and incomplete molecular profiling—underscore the urgent need for:

Early detection via non-invasive, high-sensitivity assays.
Real-time monitoring of clonal evolution and resistance mechanisms.
Companion diagnostics (CDx) to match patients with optimal therapies.

At Alfa Cytology, we turn these challenges into opportunities through science-driven, clinically actionable diagnostic solutions.

Biomarker Discovery & Validation

Genomic, Epigenetic, and Proteomic Biomarker Screening
AI-Driven Multi-Omics Signature Identification (RNA-seq, WES, Methylation Arrays)
Tissue-Based Biomarker Localization (IHC, Multiplex IF)

Liquid Biopsy Technology Development

ctDNA Detection Platforms (ddPCR, NGS, Methylation-Specific Assays)
CTC Enrichment, Isolation, and Molecular Profiling
Exosome-Based Biomarker Analysis for Early Detection

Companion Diagnostic (CDx) Co-Development

Target-Specific Assay Design (e.g., KRAS/BRAF Mutations, MSI/MMR Status)
Analytical Validation (Sensitivity, Specificity, LoD/LoQ)

Cross-Platform Validation (IHC vs. PCR vs. NGS)

Automation and Scalability Solutions for High-Throughput Testing
Stability Testing Under Predefined Storage Conditions

AI-Enhanced Diagnostic Model Building

Machine Learning Algorithms for Risk Stratification
Predictive Models Integrating Multi-Modal Data (Imaging, Genomics, Clinical)
Regulatory & Compliance Support

Spatial Transcriptomics for Tumor Microenvironment Mapping

Single-Cell Sequencing for Rare Cell Population Analysis

Partner with Us to Redefine CRC Diagnostics

At Alfa Cytology, we don’t just develop assays—we build decision-enabling tools that transform CRC care. Whether you’re advancing a novel therapeutic, seeking CDx co-development, or exploring early detection technologies, our team delivers:

End-to-end expertise: From discovery to regulatory submission.
Customization: Tailored solutions for niche subtypes (e.g., CMS4, RAS-mutant).
IP protection: Secure, collaborative workflows with full data ownership.

Schedule a consultation to align your diagnostic strategy with clinical and commercial goals.

FAQs

What differentiates your CRC diagnostic services?

Vertical Integration: Seamless workflow from biomarker discovery to IVD kit production.
Speed-to-Market: CRC PDX/organoid models accelerate clinical correlation studies.
Global Compliance: Parallel FDA/EMA/PMDA submissions to reduce time-to-launch.

How do you address low-abundance mutations in liquid biopsies?

Our ddPCR-based platforms achieve 0.01% sensitivity for KRAS/BRAF mutations, validated against orthogonal NGS methods.
Proprietary ctDNA enrichment protocols minimize background noise from healthy cells.

How do you ensure AI algorithm robustness?

Training on >10,000 annotated H&E slides from global CRC cohorts.
Continuous validation using prospective clinical samples and adversarial testing.

What support do you offer for post-market surveillance?

24/7 technical hotline for assay troubleshooting.
Biannual software updates incorporating latest CRC biomarkers (e.g., emerging fusion drivers).