Pharma Services from Ambry Genetics

Behind every effective drug therapy is a patient who once had only hope and now has an answer. Life-changing answers. And finding answers starts with the right diagnostic partner.

At every stage, Ambry Genetics delivers meaningful genetic insights tailored to the needs of your study. By combining rich data assets and computational power, we can streamline the drug development process for our partners and uncover the answers you seek in a more timely and efficient manner.

Therapeutic Areas

Every project is unique, requiring targeted expertise and deep knowledge of the disease of interest. Ambry Genetics supports your study with an experienced scientific team and capabilities spanning a wide range of therapeutic applications, including:

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

Ambry Facilities

Ambry's CLIA-approved CAP-certified, New York approved lab boasts 65,000 sq. feet of highly automated equipment, optimized for everything from large-scale, volume testing to customized research projects. We utilize top of the range sequencing, biomarker development and lab automation platforms including:

  • Illumina® MiSeq®, NextSeq® 500 Dx and NovaSeq® 6000
  • PacBio® Revio® and Sequel IIe
  • Agena Mass Spectrometer
  • Tecan® Liquid Handlers
  • Thermo Scientific KingFisher® Extraction
  • Thermo Fisher QuantStudio®
  • Bio-Rad® QX200 ddPCR
  • Promega® OncoMate® MSI Dx
  • Array SNP and CMA

Quality Management System

Ambry has a department of professionals dedicated to managing and administering key elements of our Quality Management System (QMS). We follow Good Clinical Laboratory Practices (GCLP) while incorporating ISO 13485 and FDA guidance for design controls. We maintain our Service Organization Control (SOC2) Certification through the implementation of strict guidelines for:

  • Licensure & credentialing
  • Disaster recovery
  • Proficiency testing
  • Sample chain of custody

Companion Diagnostics

Developing CDx therapies takes more than just scientific expertise. In addition to our cutting edge genetic testing services, Ambry provides the operational and regulatory support to bring your CDx to market, offering experience in:

  • Design control
  • ISO 13485
  • ISO 15189
  • IVDR standards
  • Clinical Trial Assay (CTA) development
  • Investigational Device Exemption (IDE) submission
  • Validation based on CLSI guidelines

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