Preclinical Research
and Regulatory Services
Our preclinical support begins with millions of healthy and disease state biospecimens along with the lab capabilities to investigate disease biology and target expression, and to develop complex biomarker assays that can be moved into the clinical phase. We also support development of clinical biomarker strategies, as well and companion diagnostics programs.
Biospecimens to support preclinical development of therapeutics and diagnostics
With a biorepository of over 10 million healthy and disease-state biospecimens, along with the ability to prospectively collect virtually any specimens needed, Precision can support your therapeutic and diagnostic research needs.
Explore some of the biospecimen types available:
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Specialty assay development
Precision supports preclinical development through biomarker assay development, with a focus on large molecule bioanalysis and immunogenicity assays. Examples of our expertise include:- Tissue cross-reactivity
- Immunogenicity
- Neutralizing antibody/total antibody (NAb/Tab) assays
- PK Assays
- Tissue analysis via Immunohistochemistry and Multiplex Immunofluorescence
- Sensitive analyte measurement using enzyme-linked immunosorbent assays (ELISAs) and Luminex, MesoScale Discovery (MSD), and SIMOA platforms
- Viral tissue distribution in gene therapies via ddPCR, qPCR
- Assessment of gene editing accuracy and specificity in gene editing therapies via NGS
Companion diagnostics program development
Precision’s unmatched experience in diagnostic development takes your product from bench to bedside, starting in at the preclinical phase.
- Development of biomarker assays
- Indications and claims development
- Product design considerations
- Regulatory pathway identification (eg, FDA/LDT, product class)
- POC vs. laboratory vs home use
- CLIA/QMS compliance strategy
