The FDA has approved the qualification of the safety biomarker panel to aid in the detection of kidney tubular injury!

The FDA has approved the qualification of the safety biomarker panel to aid in the detection of kidney tubular injury!

Biomarker Panel: KIM-1,cystatin C, NGAL, clusterin, osteopontin and NAG

Context of Use: A safety composite biomarker panel can be used in conjunction with traditional measures to aid in the detection of kidney tubular injury in phase 1 trials in healthy volunteers when there is an a priori concern that a drug may cause renal tubular injury in humans.

All urine biomarker assay analytical and clinical study data were generated at Pacific Biomarkers.

Introducing Ella™

Protein Simple – Ella™ is the latest platform to meet our standards of Performance & Reliability.

  • Microfluidics technology
  • Extensive menu
  • No cross reactivity or carryover
  • Exceptional precision
  • Reduced hands on time, sample volume, waste and maintenance

Announcing the Appointment of Cheikh Kane, PhD as Director of Bioanalytical Services

Cheikh brings with him 15 years of Immunoassay experience for large molecules. Dr. Kane brings scientific depth, regulatory knowledge, and extensive problem solving skills in the immunogenicity assay development area.

Cheikh Kane, PhD
Director of Bioanalytical Services

Read our recently published article in the Journal of Applied Laboratory Medicine (JALM):

Impact of Hydrophobic Non-Specific Binding on Assay Recovery for Some Urinary Biomarkers of Acute Kidney Injury. Download PDF

Authors: Candace M. Adamo, Amar A. Sethi, Timothy H. Carlson

Our Expertise, Your Drug.

Developing specialty biomarkers can be complex. Partner with us for access to cutting-edge biomarker analysis services for every stage of your drug development.

Talk with a scientist to discuss how we
can partner in your next project

Singulex Erenna® Immunoassay Technology

Pacific Biomarkers’ services portfolio includes ultra-sensitive biomarker assays using the Singulex Erenna Immunoassay technology.

Talk with a scientist to discuss how we
can partner in your next project

Aushon BioSystems Ciraplex™ ULTRA Ultrasensitive Assays

Read Press Release View Presentation

Biomarker Testing Services Specializing in
Phase I – IV Studies Read Article

Biomarker Menu Search:

Use this tool to search our offerings of over 300+ validated assays.

The Pacific Biomarkers Mobile App, available on the Apple App Store and Google Play!

Download now for phones and tablets from…

Our Mobile App provides access to new innovative tools, such as the Biomarker Navigator™ click below to learn more.

Learn More

Featured Presentation:

Platform comparison study testing multiple ultra-sensitive assay technologies presented by Dr. Maribeth Raines, Ph.D., our Vice President of Laboratory Services at the Biomarker World Congress (May 2016).

Presented by Maribeth Raines, Ph.D.

Download PDF

Pacific Biomarkers at a Glance

OVER
50
assay validations and technical transfers a year
14
average years of experience per personnel
200+
Pacific Biomarkers supports over 200 clients worldwide
Expanded capabilities with partner labs in China (Wuxi AppTech) and India (Syngene)
CAP & CLIA
Accredited
NYSDOH
Certified

Platforms and Services:

Immunoassay Platforms

  • Protein Simple- Ella™
  • MSD Quickplex*
  • Aushon Cira*
  • Singulex Erenna
  • Randox Evidence Investigator*
  • Synergy H4
  • LI-COR Odyssey

*multiplex capabilities

Automated

  • Roche Cobas e411 (immunoassay)
  • Roche Cobas c501 (clinical chemistry)
  • DPC Immulite (immunoassay)
Instrument Comparison

Methods

  • ELISA (EIA)
  • RIA (Radioimmunoassay)
  • Ultracentrifugation
  • Precipitation

The Expertise of Pacific
Biomarkers

Tonya K. Aggoune
Vice President of Project Services

Tonya Aggoune is the Vice President of Project Services which includes responsibility for the Project Management, Data Management, and Information Technology Departments of Pacific Biomarkers.

Amar A. Sethi, MD, PhD
President & Chief Scientific Officer

Dr. Sethi provides leadership and strategic direction for the Company. He is responsible for evaluating and setting the Company’s scientific priorities, coordinating administrative structures and developing business relationships within the scientific and client communities.

    For information about what data we collect and how it is stored and used, please click here
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    For information about what data we collect and how it is stored and used, please click here
    For information about what data we collect and how it is stored and used, please click here
  • This field is for validation purposes and should be left unchanged.
    For information about what data we collect and how it is stored and used, please click here

From the Pacific
Biomarkers Library:

Association of Apolipoprotein B and Nuclear Magnetic Resonance Spectroscopy-Derived LDL Particle Number with Outcomes in 25 Clinical Studies

Assessment by the AACC Lipoprotein and Vascular Diseases Division Working Group on Best Practices Click here for white paper

The Value of Client Team

Each client team at Pacific Biomarkers incorporates experience from expert scientists, business managers and project services. This team collaborates with a sponsor to provide preanalytical oversight, an innovative menu and exceptional services through direct scientific and technical consultation. Efficient timelines are maintained and optimal outcomes are provided to achieve drug product differentiation for the client.

Read more on how our team approach can work for you

Did You Know?

Nearly 30 million people battle diabetes and every 23 seconds someone new is diagnosed. Diabetes causes more deaths a year than breast cancer and AIDS combined.

Over the last several years, Pacific Biomarkers has actively supported the American Diabetes Association, donating over $31,000 in 5 years. In 2015, we ranked #3 in corporate philanthropy for the ADA.