← Back to All Services
Precision Medicine Solutions
Personalized treatment strategies based on genomic profiling and AI-driven therapeutic recommendations for improved patient outcomes
At BioCogniz, we're at the forefront of transforming healthcare through precision medicine—where treatment decisions are guided by each patient's unique genetic makeup, molecular profile, and clinical characteristics. Our comprehensive precision medicine solutions combine cutting-edge genomic technologies with artificial intelligence to deliver personalized diagnostics, targeted therapies, and predictive insights that improve clinical outcomes and reduce healthcare costs.
From biomarker discovery and validation to clinical decision support systems, we partner with healthcare providers, pharmaceutical companies, diagnostic laboratories, and research institutions to translate genomic discoveries into actionable clinical applications.
85%
Improved Treatment Response
50%
Reduction in Adverse Events
40%
Lower Healthcare Costs
2-3x
Faster Diagnosis Time
🎯 The Promise of Precision Medicine
Precision medicine represents a paradigm shift from "one-size-fits-all" to personalized healthcare:
- Right Drug, Right Dose, Right Patient: Match treatments to individual genetic profiles for maximum efficacy
- Proactive Prevention: Identify disease risk before symptoms appear, enabling early intervention
- Reduced Trial-and-Error: Eliminate ineffective treatments, saving time and reducing side effects
- Cost-Effective Care: Avoid expensive treatments that won't work for specific patients
- Accelerated Drug Development: Stratify patients in clinical trials for faster approval of targeted therapies
Our Precision Medicine Services
🧬 Biomarker Discovery & Validation
Identify and validate molecular biomarkers that predict disease risk, prognosis, treatment response, and clinical outcomes.
- Discovery Phase: Multi-omic profiling (genomics, transcriptomics, proteomics) to identify candidate biomarkers
- Machine Learning Models: AI algorithms to identify predictive biomarker signatures
- Statistical Validation: Rigorous testing in independent cohorts with survival analysis
- Clinical Utility Assessment: ROC analysis, sensitivity/specificity optimization
- Regulatory Support: Documentation for FDA/EMA biomarker qualification
- Assay Development: Translation to clinical laboratory tests (PCR, immunoassays)
💉 Treatment Response Prediction
Predict patient response to specific therapies using genomic data and machine learning, enabling precision treatment selection.
- Predictive Modeling: AI algorithms trained on treatment outcome data
- Drug Response Signatures: Gene expression profiles predicting efficacy
- Resistance Mechanism Analysis: Identify mutations causing treatment failure
- Multi-Drug Comparison: Rank treatment options by predicted effectiveness
- Toxicity Prediction: Forecast adverse event risk based on genomic markers
- Longitudinal Monitoring: Track molecular changes during treatment
💊 Companion Diagnostics Development
Develop and validate diagnostic tests that identify patients most likely to benefit from specific targeted therapies.
- Target Identification: Define biomarkers linked to drug mechanism of action
- Assay Design & Optimization: NGS panels, PCR, IHC, or other platforms
- Clinical Validation Studies: Concordance with treatment outcomes
- Regulatory Strategy: FDA/EMA companion diagnostic approval pathway
- Co-Development Support: Parallel drug-diagnostic development
- CLIA Lab Implementation: Transfer to clinical diagnostic laboratories
🏥 Clinical Decision Support
AI-powered clinical decision support systems that integrate genomic data with clinical information to guide treatment decisions.
- Variant Interpretation: Automated classification of pathogenicity (ACMG guidelines)
- Treatment Recommendations: Evidence-based therapy suggestions from genomic data
- Drug-Drug Interactions: Predict interactions based on pharmacogenomics
- Clinical Trial Matching: Identify eligible trials based on molecular profile
- Real-Time Alerts: Actionable insights delivered at point of care
- EMR Integration: Seamless workflow within existing hospital systems
🧬 Pharmacogenomics Analysis
Comprehensive analysis of genetic variations that affect drug metabolism, efficacy, and toxicity for personalized dosing and drug selection.
- PGx Panel Testing: CYP450 enzymes, transporters, drug targets (DPYD, TPMT, SLCO1B1, etc.)
- Dose Optimization: Warfarin, clopidogrel, tacrolimus, and other critical drugs
- Pre-Emptive Testing: Genotype patients before treatment initiation
- Adverse Event Prevention: Identify risk for severe drug reactions (HLA-B*5701, etc.)
- Drug Selection Guidance: Choose medications based on metabolizer status
- CPIC/PharmGKB Integration: Evidence-based guideline implementation
🌍 Population Genetics Studies
Large-scale genomic studies to understand disease prevalence, genetic risk factors, and treatment response across diverse populations.
- GWAS (Genome-Wide Association Studies): Identify genetic variants associated with disease
- Polygenic Risk Scores: Calculate cumulative genetic risk for complex diseases
- Ancestry Analysis: Population stratification and admixture mapping
- Rare Variant Analysis: Burden tests and gene-based association
- Ethnic Diversity Studies: Ensure precision medicine benefits all populations
- Founder Mutations: Identify population-specific pathogenic variants
Clinical Pathway Integration
Our precision medicine solutions integrate seamlessly into clinical workflows:
1
Patient Enrollment
Sample collection and informed consent
2
Genomic Testing
NGS sequencing and quality control
3
AI Analysis
Variant calling and interpretation
4
Clinical Report
Actionable findings delivered to providers
5
Treatment Decision
Precision therapy selection and dosing
6
Outcome Monitoring
Track response and adjust as needed
Therapeutic Areas
We provide precision medicine solutions across multiple clinical specialties:
🎗️ Oncology
- Tumor mutational profiling
- Targeted therapy selection
- Immunotherapy biomarkers (TMB, MSI, PD-L1)
- Liquid biopsy for monitoring
- Hereditary cancer syndromes
❤️ Cardiology
- Familial hypercholesterolemia
- Cardiomyopathy genetic testing
- Pharmacogenomics (warfarin, statins, clopidogrel)
- Sudden cardiac death risk
- Polygenic risk scores for CAD
🧠 Neurology
- Alzheimer's disease risk (APOE)
- Epilepsy gene panels
- Parkinson's disease genetics
- Pharmacogenomics for psychiatric drugs
- Rare neurological disorders
👶 Pediatrics
- Newborn screening expansion
- Rare disease diagnosis
- Developmental disorder genomics
- Pharmacogenomics for pediatric dosing
- Metabolic disorders
🔬 Infectious Disease
- Antimicrobial resistance profiling
- HIV drug resistance testing
- HCV genotyping for treatment
- Host genetics affecting infection
- Vaccine response prediction
🩺 Rare Diseases
- WGS/WES for diagnosis
- Variant interpretation pipelines
- Functional validation studies
- Natural history studies
- N-of-1 precision therapies
Why Choose BioCogniz for Precision Medicine?
🏆 Clinical Expertise
Team includes MDs, PharmDs, and genetic counselors with clinical genomics experience
🤖 AI-Powered Insights
Machine learning models trained on millions of patient outcomes for superior predictions
📋 Regulatory Experience
Proven track record supporting FDA/EMA submissions for biomarkers and diagnostics
🔐 HIPAA Compliance
Bank-grade security with full compliance for protected health information
🌐 Population Diversity
Models validated across diverse ethnic populations for equitable healthcare
⚡ Rapid Turnaround
Clinically actionable reports delivered in days, not weeks
Success Stories
ONCOLOGY BIOMARKER
Companion Diagnostic for Targeted Cancer Therapy
Challenge: Pharmaceutical company developing a novel kinase inhibitor needed a companion diagnostic to identify responsive patients in clinical trials.
Solution: We performed multi-omic profiling of responders vs. non-responders, discovered a 12-gene expression signature, and developed a qPCR-based diagnostic assay.
Results:
- 92% sensitivity and 87% specificity for treatment response prediction
- Enriched trial population increased response rate from 18% to 64%
- FDA approved drug-diagnostic combination, accelerating market access
- Companion diagnostic now used in 40+ countries
PHARMACOGENOMICS
Hospital-Wide PGx Implementation
Challenge: Major academic medical center wanted to implement pre-emptive pharmacogenomic testing to reduce adverse drug events.
Solution: Designed a 40-gene PGx panel, developed clinical decision support system integrated with EMR, and trained pharmacy and clinical staff.
Results:
- Tested 5,000+ patients in first year of implementation
- 48% reduction in serious adverse drug events
- Identified 23% of patients at high risk for standard dosing
- Estimated $2.8M annual cost savings from prevented ADEs
RARE DISEASE
Diagnostic Odyssey Resolution
Challenge: Pediatric patient with undiagnosed developmental disorder after 8 years of inconclusive testing.
Solution: Performed trio WGS (patient + parents), used AI-powered variant prioritization, and functional validation of candidate variants.
Results:
- Identified ultra-rare de novo mutation in novel disease gene
- Diagnosis confirmed by functional studies in 6 weeks
- Enabled targeted treatment and genetic counseling for family
- Findings published in American Journal of Human Genetics
Ready to Transform Patient Care with Precision Medicine?
Partner with BioCogniz to bring personalized medicine to your patients and accelerate your precision health initiatives
Schedule Consultation
Request Proposal
Our Precision Medicine Process
1. Discovery & Consultation
We begin with a comprehensive consultation to understand your clinical question, patient population, available data, and desired outcomes. Our team includes clinicians who speak your language and understand the regulatory and reimbursement landscape.
2. Study Design & Data Generation
We design statistically powered studies with appropriate controls, identify optimal genomic assays (targeted panels, WES, WGS, RNA-Seq), and coordinate with clinical sites for sample collection and IRB approval.
3. AI-Powered Analysis
Our machine learning algorithms analyze genomic data in the context of clinical outcomes, treatment responses, and patient demographics to identify actionable biomarkers and build predictive models.
4. Clinical Validation
We validate findings in independent cohorts, assess clinical utility through decision curve analysis, and benchmark against standard of care. All claims are supported by rigorous statistics and peer-reviewed methodology.
5. Translation & Implementation
We develop clinical-grade assays, create physician-friendly reports, integrate with EMR systems, and provide training for clinical staff. Post-launch support ensures smooth adoption.
6. Regulatory Support
For diagnostic development, we prepare FDA Pre-Sub briefing documents, design and execute clinical validation studies, compile regulatory submissions, and coordinate with agency reviewers.
Frequently Asked Questions
Q: What's the difference between precision medicine and personalized medicine?
A: The terms are often used interchangeably. Precision medicine emphasizes using molecular data (genomics, proteomics) to categorize patients into subgroups that respond differently to treatments. Personalized medicine has a broader definition that includes any individualized approach to healthcare, including lifestyle and environmental factors. At BioCogniz, we focus on data-driven, molecular-based precision medicine.
Q: How long does it take to develop a companion diagnostic?
A: The timeline varies significantly based on complexity and regulatory requirements. Biomarker discovery and analytical validation typically takes 6-12 months. Clinical validation studies add another 12-24 months. FDA review processes can take 6-12 months. Total timeline from discovery to approval is typically 3-5 years. However, we can accelerate this through parallel development with the therapeutic.
Q: Do you provide genetic counseling services?
A: While we don't directly provide genetic counseling to patients, we work closely with certified genetic counselors and can help connect you with appropriate resources. For clinical implementation projects, we can facilitate training for your existing genetic counseling team.
Q: How do you ensure patient data privacy and security?
A: We are fully HIPAA compliant with encrypted data storage, secure data transfer protocols, access controls, audit trails, and regular security audits. We sign Business Associate Agreements (BAAs) for all clinical projects. Patient data is de-identified whenever possible, and we never share data without explicit permission.
Q: What sample types do you accept?
A: We work with DNA from blood, saliva, buccal swabs, fresh/frozen tissue, FFPE blocks, and cell-free DNA from plasma. For RNA studies, we accept whole blood in PAXgene tubes, fresh/frozen tissue, and FFPE tissue. Minimum input requirements vary by assay—contact us to discuss your specific samples.
Q: Can you help with reimbursement strategy for new diagnostics?
A: Yes! We provide health economics outcomes research (HEOR), assist with CPT code applications, prepare dossiers for payer negotiations, and design studies to demonstrate clinical utility and cost-effectiveness—critical for reimbursement decisions.
Q: Do your models work for diverse patient populations?
A: This is a critical issue in precision medicine. We prioritize inclusion of diverse populations in training data, validate models across ethnic groups, assess for algorithmic bias, and develop population-specific adjustments when needed. We believe precision medicine should benefit all patients equitably.
Related Services