News

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

There is a lot of confusion in the world of biomarker testing when it comes to the terms ‘assay qualification’ and ‘assay validation’. These two terms are not strictly defined and are even used interchangeably at times. This confusion stems from the diverse scientific backgrounds and disciplines of those of us working in the biomarker field.

Click for full article

Featured Expert

Daniel Worms, Ph.D. Associate Principal Investigator — Daniel Worms,
Ph.D. Associate Principal Investigator

Todd Lester Associate Director — Todd Lester
Associate Director

Nathan Rudemiller Ph.D. Associate Director — Nathan Rudemiller
Ph.D. Associate Director

Jennifer Zemo Ph.D. Director — Jennifer Zemo
Ph.D. Director

Jessica Weaver Manager II & Bioanalytical Project Manager — Jessica Weaver
Manager II & Bioanalytical Project Manager

Krystal Alligood Associate Director — Krystal Alligood
Associate Director

Laura Lassen Director — Laura Lassen
Director

Luke Armstrong Ph.D. Manager II — Luke Armstrong
Ph.D. Manager II

Michelle Miller Ph.D. DABT Associate Director — Michelle Miller
Ph.D. DABT Associate Director

Jennifer Johnson Manager I — Jennifer Johnson
Manager I

Jennifer T. Durham Ph.D. Associate Director of Scientific Services, BioAgilytix — Jennifer T. Durham
Ph.D. Associate Director of Scientific Services, BioAgilytix

Jeff Patrick Ph.D. Director of GMP Operations, BioAgilytix — Jeff Patrick
Ph.D. Director of GMP Operations, BioAgilytix

Janina Hajek Ph.D. Principal Investigator — Janina Hajek
Ph.D. Principal Investigator

Janett Schwarz Ph.D. Principal Investigator — Janett Schwarz
Ph.D. Principal Investigator

Imke Müller Ph.D. Director, Principal Investigator — Imke Müller
Ph.D. Director, Principal Investigator

Carla Gibbons Senior QA Director — Carla Gibbons
Senior QA Director

Carla Mejia Manager II — Carla Mejia
Manager II

Daniel Worms Ph.D. Associate Principal Investigator — Daniel Worms
Ph.D. Associate Principal Investigator

David Rusnak Director Bioanalytical Operations — David Rusnak Director
Bioanalytical Operations

Florian Anlauff Ph.D. Principal Investigator — Florian Anlauff
Ph.D. Principal Investigator

Frank Wischnewski Ph.D. Associate Director — Frank Wischnewski
Ph.D. Associate Director

Anita Simkins Senior Vice President, Global Quality Assurance — Anita Simkins
Senior Vice President, Global Quality Assurance

Anne Timmerman Ph.D. Associate Principal Investigator — Anne Timmerman
Ph.D. Associate Principal Investigator

Ask a Question

Schedule a Conversation

Meet All of Our Experts

Pharmacokinetics & Pharmacodynamics

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.