Million
Biospecimens Managed
Labs
CAP,CLIA,ISO, & FDA-Registered
+
Trials Conducted for IVD, CDx & Therapeutics
Million
PBMC, DNA & RNA Isolations
+
Countries with real-time sample processing
EBOOK

Successful Strategies for Biomarker-Driven Research & Clinical Development

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ARTICLE

Applying Immunohistochemistry to Diagnostic Development

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PRODUCT

Leukopaks

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Our Biospecimens

Blood, Biofluids, and Derivatives

Diseased and healthy human blood, plasma, serum, CSF, stool, ascites fluid, saliva, urine and more.

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Tissues

Pathologist-verified, fresh, frozen, and fixed tissue specimens from healthy and diseased human subjects.

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Viable Cells

HLA-typed cellular products including PBMCs, BMMCs, Leukopaks, DTCs and more.

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Remnant Diagnostic Specimens

Remnant laboratory specimens characterized by FDA-cleared and ROW assays.

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Liquid Biopsy

Comprehensive services including kitting, collection, processing, & profiling from your patients or ours.

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Custom Biospecimen Collections

Global clinical network, regulatory approved, and ready to enroll.
 

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Webinar Series

Part 1: Sourcing the Right Biospecimens

Date: January 13th
Time: 11:00 AM ET

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Webinar Series

Part 2: Generating Data From Your Biospecimens

Date: February 10th
Time: 11:00 AM ET

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Webinar Series

Part 3: Computational Approaches for Biospecimen Analysis

Date: March 11th
Time: 11:00 AM ET

Watch Now

Our Solutions and Services

Biomarker-driven labs, analysis, and trials for all stages of drug and diagnostic development, backed by a responsive team of industry veterans. Learn about our array of services here at the biorepository and at our other Precision for Medicine sites.

World-Renowned Biorepository

100,000 Sq. ft. CAP-certified biorepository providing specimen processing, storage, management, logistics, and distribution of your critical research specimens.

Biomarker & Specialty Lab Services

Precision for Medicine has a global footprint of CLIA, CAP, GCP specialty labs available to generate robust biomarker data for your research projects. Explore the Precision for Medicine lab services below to learn how we can help with your scientific research and development activities.

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Flow cytometry analysis of biospecimens

Regulatory Strategy

Our experts can support you through regulatory strategy and submissions for CDx, IVD, and LDTs. Our team has helped hundreds of clients gain authorizations, clearances, and approvals for their diagnostics.

  • Regulatory pathway and strategy
  • Global submissions including United States (EUA, 510(k), De Novo, PMA), European Union (CE Mark to IVDD and IVDR), Japan (PMDA), Health Canada, and more, applied to traditional in vitro diagnostics, LDTs, or CDx
  • Presubmission package development
  • Quality systems implementation and oversight

Commercial Consulting

Our team of experienced market access and reimbursement strategists can help you develop and execute on your go-to-market strategy.

  • Market access and channel optimization
  • Coding and payment strategy and support
  • Assay platform and format selection
  • Utility demonstration and access to coverage

Study Specimen Collection Kits

Study-specific specimen collection kits designed to simplify enrollment and maximize your specimen and data quality.

Clinical Trial Services and Management

End-to-end CRO services for your biomarker-driven clinical trials.

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Data analysis of flow cytometry data

Data Science

Data aggregation, harmonization, and analysis for your biomarker program leveraging our proprietary QuartzBio platform and team.

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Join more than 1,600 companies and 14,000 research projects that trust Precision for Medicine.

World Class Standards & Certifications