Pharma Services
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Pharma Services

Ambry provides the specialized test menus, targeted clinical trial support, and real-world data services to help biopharmaceutical partners streamline drug development and advance precision medicine.

Core Capabilities

At every stage of the drug development pipeline, Ambry delivers scalable genomic solutions tailored to the operational demands of biopharma research. By pairing real-world database insights with computational power, we help partners streamline the process and meet study timelines across three core areas:

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Pharma Test Menu

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Clinical Trial Support and Patient Identification

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Real World Data Services

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Therapeutic Areas

Ambry supports studies with an experienced scientific team and deep expertise spanning a wide range of therapeutic areas, including:

  • Oncology
  • Neurology
  • Cardiovascular Diseases
  • Gene Therapy
  • Gastroenterology
  • Rare Diseases
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Ambry Facilities

Our 65,000-square-foot facility is CLIA-certified, CAP-accredited, and New York-approved. The lab supports high-volume testing and custom research projects using industry-leading platforms for sequencing, biomarker development, and automation, including:

  • Short-Read NGS: Illumina® MiSeq®, NextSeq® 500 Dx, NovaSeq® 6000
  • Long-Read NGS: PacBio® Revio®, Sequel IIe
  • Mass Spectrometry: Agena
  • Lab Automation: Tecan® Handlers, Thermo Scientific KingFisher® Extraction
  • Real-Time PCR: Thermo Fisher QuantStudio®
  • Droplet Digital PCR (ddPCR): Bio-Rad® QX200 ddPCR
  • Microsatellite Instability (MSI) Analysis: Promega® OncoMate® MSI Dx
  • Array SNP and Chromosomal Microarray (CMA)
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Quality Management System

Ambry maintains a comprehensive Quality Management System (QMS) aligned with Good Clinical Laboratory Practices (GCLP), ISO 13485, and FDA design control guidance. To ensure data integrity and operational security, Service Organization Control (SOC 2) certification is maintained with strict guidelines for:

  • Licensure and Credentialing
  • Disaster Recovery
  • Proficiency Testing
  • Sample Chain of Custody
Companion Diagnostics
Companion Diagnostics

Beyond industry-leading genetic testing services, Ambry provides the regulatory and operational support necessary to bring companion diagnostics (CDx) to market, with established expertise in:

  • Design Controls: FDA guidance compliance
  • Quality Standards: ISO 13485 and ISO 15189 certifications
  • Global Compliance: European IVDR standards
  • Assay Development: Custom clinical trial assay (CTA) development
  • Regulatory Submissions: Investigational Device Exemption (IDE) submissions
  • Assay Validation: Strict alignment with CLSI validation guidelines