Bio Gen Labs
Laboratory scientist examining a specimen

Who We Are

A national laboratory built around one goal: better patient care

Bio Gen Labs combines automated laboratory science with a nationwide courier network and a team of board-certified pathologists to deliver fast, accurate results providers can trust.

CLIA Certified
CAP Accredited
HIPAA Secured
Medicare Approved

0+ yrs

Diagnostic experience

0 states

Licensed nationwide

0M+

Specimens processed annually

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Average turnaround time

Clinician preparing a diagnostic sample

Mission

To provide fast, accurate, and accessible diagnostic testing that empowers providers to make confident clinical decisions for every patient, everywhere.

Laboratory worker examining a specimen

Vision

A healthcare system where every provider — regardless of size or location — has access to enterprise-grade diagnostics and genuinely responsive laboratory support.

What Drives Us

Core values

The principles that guide every decision, from the bench to the boardroom.

Integrity

We hold ourselves to the highest ethical standard in every result we report and every relationship we build.

Precision

Meticulous attention to detail across every step of the testing lifecycle, from specimen intake to final report.

Innovation

We continuously invest in emerging assay technology and automation to stay ahead of clinical need.

Compassion

Every specimen represents a patient waiting on an answer — we treat that responsibility with urgency and care.

Accountability

We own our outcomes, measure what matters, and hold ourselves to rigorous internal standards.

Collaboration

We partner closely with providers, care teams, and each other to deliver dependable diagnostics.

Leadership

Meet our leadership team

Experienced clinical, scientific, and operational leaders guiding Bio Gen Labs forward.

Dr. Elena Cortez, MD

Dr. Elena Cortez, MD

Chief Medical Director

Board-certified in clinical pathology, Dr. Cortez oversees medical and scientific direction across all Bio Gen Labs testing services.

Raymond Achebe

Raymond Achebe

Chief Executive Officer

Raymond leads corporate strategy and operations, with a background scaling reference laboratory networks nationally.

Dr. Amara Whitfield, PhD

Dr. Amara Whitfield, PhD

Director of Molecular Diagnostics

Dr. Whitfield leads assay development and validation for the molecular diagnostics service line.

Sofia Marchetti

Sofia Marchetti

VP, Quality & Compliance

Sofia manages the quality management system, regulatory compliance, and accreditation readiness across the organization.

Quality control testing in the lab

Quality Assurance

A quality management system built into every result

Bio Gen Labs maintains a comprehensive quality management system covering proficiency testing, personnel competency assessment, and continuous process monitoring, built to meet CLIA, CAP, and HIPAA standards across the entire testing lifecycle.

Proficiency Testing

Every discipline we offer is enrolled in accredited proficiency testing programs, verified against outside reference labs multiple times a year.

Competency Assessment

Technologists complete structured competency reviews on a recurring basis, covering both instrumentation and manual methods.

Process Monitoring

Instrument calibration, reagent lot verification, and control runs are tracked continuously across every testing platform.

Corrective Action

Any deviation triggers a documented root-cause review, corrective action, and effectiveness check before it's closed out.

Accreditation

Laboratory certifications

Independently verified against national standards for accuracy, safety, and data protection.

CLIA Certified

Certified under the Clinical Laboratory Improvement Amendments for high-complexity testing.

CAP Accredited

Inspected biennially by the College of American Pathologists against rigorous quality benchmarks.

HIPAA Secured

Encrypted infrastructure and access controls protecting patient data at every touchpoint.

Medicare & Medicaid Approved

Recognized billing provider with approved status across federal and state programs.

Licensed Nationwide

Licensed to operate across all 50 states, including state-specific clinical laboratory permits.

Proficiency Verified

Independently verified performance across chemistry, molecular, toxicology, and genetics testing.

Technology

Automation and connectivity that keep results moving

From specimen intake to final report, our infrastructure is built for speed and traceability — automated instrumentation, integrated ordering, and secure digital delivery, all in one connected system.

  • Automated Chemistry & Immunoassay Analyzers

  • Bi-Directional LIS & EHR Integration

  • Electronic Order & Requisition Portal

  • Real-Time Specimen Tracking

  • Encrypted, Auditable Result Delivery

  • Barcode-Driven Chain of Custody

Chemist using a micropipette

Research

Advancing diagnostic science

Our scientific team continuously validates new assays and partners with academic and clinical collaborators to expand what's possible in diagnostics.

Under the direction of our molecular diagnostics team, Bio Gen Labs invests in assay development, method validation, and applied research designed to bring emerging testing capabilities into routine clinical use faster.

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Validated assays

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Active research collaborations

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Peer-reviewed publications

0M+

Annual R&D investment

Compliance

Regulatory compliance you can verify

A closer look at the frameworks and internal controls that keep Bio Gen Labs accountable at every level.

Our laboratory holds a CLIA certificate of accreditation covering high-complexity testing, with personnel qualifications, quality control, and proficiency testing programs audited on a recurring cycle.

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