Omega Genetics

Genomic and molecular analyses — translating pharmacogenomic and biomarker-driven data into clinically meaningful outcomes through validated methods and bioinformatics expertise.

Compliance: ICH-GCP GCLP ALCOA+ Chain-of-Custody CAPA

Pharmacogenomic & Biomarker-Driven Testing

Genomic and molecular analyses play a critical role in clinical research with respect to patient safety, patient selection and stratification, monitoring of treatment response, and translational research objectives.

The HelixLab and Omega Genetics infrastructure aims to deliver outputs aligned with clinical studies through protocol-compliant sample management, standardized analytical workflows, data integrity, and audit readiness.

For clinical research, pharmacogenomic (PGx) and biomarker-driven genomic and molecular testing is supported by medical genetics and bioinformatics expertise, covering study design, analysis, interpretation, and data packages.

Integration Within the Omega Ecosystem

HelixLab — sample management, pre-analytical standardization, central lab workflows
Omega Genetics — medical genetics-driven analysis, NGS validation, confirmatory testing
Omega Bio — kit-based analytical infrastructure for molecular techniques
Biorepository — traceable sample management for long-term storage and re-analysis
Omega Care — home sampling and standardized packaging/transport workflows
IWRS — kit-to-sample matching and operational notification workflows

Sequencing & Panel-Based Solutions

Receptor Repertoire Profiling

B-cell and T-cell receptor repertoire profiling for immunotherapy research and immune response monitoring.

Targeted Gene Panels

Small and large gene panels — Familial Hypercholesterolemia, Myeloid panels, DNA damage repair genes, and custom panels.

Whole Exome Sequencing (WES)

Comprehensive exome capture for protein-coding region analysis across all disease types.

Whole Genome Sequencing (WGS)

Complete genome analysis for comprehensive variant detection, structural variants, and non-coding regions.

Germline & Somatic Mutation Analysis

Paired tumor-normal analysis, germline mutation detection across disease types, and somatic variant calling.

RNA Sequencing (RNAseq)

Gene expression signatures, fusion detection, and alternative splicing analysis.

Oncology & Immunotherapy-Focused Analyses

MSI & MMR Testing

Microsatellite Instability (MSI) and Mismatch Repair (MMR) testing for immunotherapy eligibility assessment.

Minimal Residual Disease (MRD)

MRD assessment for treatment response monitoring and relapse prediction in hematologic malignancies.

Tumor Mutational Burden (TMB)

TMB calculation for immunotherapy research — quantifying the number of somatic mutations per coding area.

Liquid Biopsy & cfDNA

Cell-free DNA (cfDNA) analysis using NGS or digital PCR (dPCR) for non-invasive tumor monitoring.

Microbiome & Metagenomic Sequencing

Shotgun Metagenomics

Comprehensive microbiome profiling capturing all microbial DNA in a sample. Enables species-level identification, functional gene analysis, and antimicrobial resistance gene detection.

Ideal for gut microbiome studies in gastroenterology trials, immunotherapy response correlation, and dietary intervention research.

16S rRNA Sequencing

Targeted amplicon sequencing of the 16S ribosomal RNA gene for bacterial community profiling and taxonomic classification.

Cost-effective approach for large-scale microbiome studies requiring high-throughput sample processing.

DNA & RNA Analyses

  • • DNA isolation with concentration, purity, and yield assessment
  • • RNA isolation with concentration, integrity, and yield assessment
  • • Quality control metrics per sample type
  • • Quantification using fluorometric methods

Cell Processing

  • • Peripheral Blood Mononuclear Cell (PBMC) preparation
  • • Cell counting and viability analysis
  • • Cryopreservation and controlled-rate freezing
  • • Post-thaw viability assessment

Companion Diagnostics

  • • Sanger sequencing analysis
  • • Single-gene or single-mutation genotyping
  • • Fragment analysis
  • • MLPA for gene copy number determination
  • • NGS validation for companion diagnostic assays

Operational Workflow

Omega Genetics operational workflow diagram
1

Study Initiation

Review of protocol, endpoints, and biomarker requirements.

2

Test Strategy

Definition of test panels based on analyte, platform, cut-off values, and sample matrix.

3

Method Validation

Study-fit performance targets and QC plans.

4

Site Preparation

Sampling manuals, labeling, pre-analytical requirements, logistics.

5

Sample Receipt

Verification of accessioning, chain-of-custody, and storage conditions.

6

Analysis & Data Generation

Execution of planned tests, interim controls, deviation management.

7

Bioinformatics Analysis

Data processing and quality control aligned with study objectives.

8

Data Verification & Reporting

Second-level review, consistency checks, protocol-compliant format.

9

Sponsor/CRO Integration

Data transfer compatible with EDC/eCRF systems, query management.

10

Archiving & Audit Readiness

Documentation, audit trail records, inspection-ready archiving.

Planning a Study Requiring Genomic Analysis?

Share your protocol — we'll define the optimal genomic and molecular testing strategy.

Request a Feasibility Call