SERVICES

Biopharma services

Your partner in advancing cancer research and CDx development

Pharma Partnering
Laboratory Services
SERVICES OVERVIEW

From biomarker discovery to diagnosis

We partner with researchers and biopharmaceutical companies to help identify new biomarker targets and accelerate biomarker-driven drug development. Our decentralized testing model enables our partners to access more patients worldwide, supporting clinical trials and research studies. Our assays are powered by proprietary bioinformatics that automate tumor analysis and variant classification to expedite reliable, meaningful insights for current and emerging biomarkers and complex genomic signatures.

See Our Solutions
Research and discovery support

Define complex and emerging biomarkers and genomic signatures, like TMB and HRD, with our highly sensitive and accurate assays

Clinical trial assay support

Leverage our CAP/CLIA lab or our global network of CRO partners for your clinical trial needs

Global patient access

Distributed kit model enables access to patients across the globe

CDx co-development

Draw on our international regulatory expertise and deep commercialization experience

TRACK RECORD OF INNOVATION

A platform designed to support breakthrough research

PGDx sits at the forefront of medical innovation, with a proven track record of delivering cutting-edge precision diagnostic solutions to advance cancer care worldwide.

  • Developed the first FDA cleared distributed CGP NGS kit
  • Achieved the first tumor profiling clearance to include structural variants (translocations and amplifications)
  • First to show ctDNA as a universal biomarker for cancer
  • Demonstrated superior performance for somatic detection with high quality machine learning algorithms
  • Received FDA breakthrough device designation for PGDx elio plasma resolve
GLOBAL QUALITY & REGULATORY EXPERTISE

Partner with confidence

Deep expertise across the CDx development continuum ensures you can navigate the regulatory landscape with confidence, simplify your path to commercialization, and mitigate risk. Proven kitted solutions mean you’ll know where your research stands now, and in the future.

  • NGS biomarker solutions developed under design control to comply with US FDA, EU IVDD, and ISO standards (ISO13485:2016)
  • Rigorous approach to product development supports a broad range of intended uses to help meet regulatory requirements worldwide
  • 510(k) clearance of PGDx elio tissue complete, registered and listed as a medical device manufacturer, IDE approved for significant risk precision medicine trials
  • Licensed for IVD co-development on Illumina NextSeq 550 Dx™
PGDx IN CLINICAL TRIALS

PGDx is empowering breakthroughs on a global scale

Take a look at some of the clinical trials that have utilized PGDx solutions.

FIGHT trial with Five Prime

NCT03694522

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FIDES-02 and ‑03 with Basilea

NCT04045613

NCT04604132

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KEYNOTE-495 with Merck

NCT03516981

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MEDOCC-CrEATE with Netherlands National Cancer Institute (NKI)
FIGHT trial with Five Prime

NCT03694522

Learn More
FIDES-02 and ‑03 with Basilea

NCT04045613

NCT04604132

Learn More
KEYNOTE-495 with Merck

NCT03516981

Learn More
MEDOCC-CrEATE with Netherlands National Cancer Institute (NKI)
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