HELIXAFE

Test Type: Liquid biopsy with circulating cell-free total nucleic acid (cfTNA) analysis using Next Generation Sequencing (NGS)

Description:
HELIXPAN is designed to detect genomic instability through peripheral blood analysis, monitoring the progressive accumulation of genetic mutations that characterize the prodromal phase of solid tumor development. By analyzing circulating nucleic acids (DNA and RNA) extracted from plasma, HELIXPAN identifies somatic mutations in both tumor suppressor genes and driver genes, assessing their effectiveness in preserving genomic stability and preventing cancerous transformation.

Analysis Components:

• 52-Gene Comprehensive Panel: Including critical tumor suppressors (TP53, APC, PTEN, SMAD4, FBXW7, CHEK2) and oncogenic drivers
• Over 900 SNVs Detection: Single nucleotide variations and small insertions/deletions (indels) in hotspot regions
• 99 Gene Fusions: Analysis of 12 genes for chromosomal rearrangements (ALK, ROS1, RET, NTRK1, NTRK3, FGFR1-3, BRAF, ERG, ETV1, MET)
• 12 CNV-Gains: Copy number amplifications in key oncogenes (EGFR, ERBB2, MET, FGFR1-3, MYC, CCND1-3, CDK4-6)
• TP53 Deep Sequencing: Coverage of ~80% of TP53 gene with detection of de novo non-hotspot variants (≥1% allelic frequency)
• MET Exon 14 Skipping: Specific assessment of this critical splicing mutation
• Ultra-Sensitive Detection: Variants identified with allelic frequency >0.1% under optimal conditions

Key Genes Analyzed:
Hotspot genes: APC, AKT1, ALK, AR, ARAF, BRAF, CHEK2, CTNNB1, DDR2, EGFR, ERBB2, ERBB3, FBXW7, ESR1, FGFR1-4, FLT3, GNA11, GNAQ, GNAS, HRAS, IDH1-2, KIT, KRAS, MAP2K1-2, MET, MTOR, NRAS, NTRK1, NTRK3, PDGFRA, PIK3CA, PTEN, RAF1, RET, ROS1, SF3B1, SMAD4, SMO, TP53

Clinical Significance:
Progressive accumulation of somatic mutations detected by serial HELIXPAN testing indicates persistent tumor suppressor gene inactivation and increasing genomic instability—the hallmark of pre-cancerous transformation. Early identification enables targeted interventions including gene therapy, DNA demethylating agents, and personalized prevention strategies before clinical cancer develops. The test is particularly valuable for longitudinal monitoring of healthy individuals at risk, tracking tissue progression from normal to precancerous states.

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Target: Chronic low-grade inflammation (Inflammaging)

Test Type: Blood serum analysis with multiplex cytokine assay

Description:
CYTOBALANCE provides a comprehensive assessment of the inflammatory status by measuring key pro-inflammatory and anti-inflammatory cytokines. Chronic inflammation is recognized as a major driver of cancer development, creating a microenvironment that promotes tumor initiation and progression.

Clinical Significance:
Elevated inflammatory markers indicate increased cancer risk and guide targeted anti-inflammatory interventions. Serial monitoring tracks treatment response and identifies emerging inflammation patterns.

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Target: Microbiome dysbiosis and pathogenic colonization

Test Type: Metagenomic sequencing of stool and/or vaginal samples

Description:
MICROBALANCE uses advanced next-generation sequencing to comprehensively characterize the gut and vaginal microbiome. Dysbiosis has been linked to multiple cancer types including colorectal, gastric, and cervical cancers through mechanisms involving inflammation, metabolite production, and immune modulation.

Clinical Significance:
Identifies cancer-promoting bacterial signatures and guides targeted probiotic/prebiotic interventions. Vaginal microbiome assessment is particularly relevant for cervical cancer risk stratification.

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Target: DNA damage, mutations, and chromosomal aberrations

Test Type: Liquid biopsy with circulating cell-free DNA analysis

Description:
HELIXBALANCE employs cutting-edge liquid biopsy technology to detect signs of genomic instability before cancer develops. By analyzing cell-free DNA fragments circulating in the bloodstream, we can identify mutation signatures, chromosomal copy number variations, and methylation changes indicative of pre-cancerous processes.

Clinical Significance:
Provides the earliest possible detection of genomic changes that precede cancer formation. Enables risk stratification and guides preventive interventions at the molecular level.

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Target: Immune dysfunction and immunosenescence

Test Type: Flow cytometry immunophenotyping and functional assays

Description:
IMMUNEBALANCE provides a comprehensive evaluation of immune system status, assessing both innate and adaptive immunity. Immune surveillance is critical for eliminating pre-cancerous cells, and age-related immune decline (immunosenescence) significantly increases cancer risk.

Clinical Significance:
Identifies immune deficiencies that impair cancer surveillance and guides immunomodulatory interventions. Essential for monitoring immune reconstitution and optimizing immune health.

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