ProterixBio services offering
End-to-end delivery of immuno / protein assay solutions from our quality controlled CLIA certified lab
ProterixBio operates a high-complexity, CLIA-certified clinical testing laboratory (licensed in all 50 States). We have expertise in the development, validation and implementation of research-focused and clinical immunoassays for immune-mediated, cardiovascular, kidney, and neurodegenerative diseases, as well as other therapeutic areas.
We offer tiger team flexibility – we excel in enabling efficient clinical grade biomarker testing across platforms and specimen types. We are happy to provide full-service assay development, implementation and interpretation, or testing only, depending on the needs of our customers.
1. Assay development services
Our assay development services include:
- Target biomarker(s) identification and scoping of test
- Establishing reagents and technology platform most appropriate for needs of projects
- Establish methodology proof-of-concept and feasibility across specimen types (incl. micro-samples)
- Optimization of preanalytical handling, extraction methods and assay conditions
- Standards, kit formulations, formats and reference standards for quantification
- Optimization and locking-in fit-for-purpose assay performance to assure consistent reproducible results across multiple lots
2. Assay validation services
Our assay validation services include:
- Design and execution of validation protocols
- Comparison studies, reference ranges
- Analytical validation – LoB, LoD, LoQ, precision, linearity, AMR, accuracy
- Interferences, cross-reactivity
- Additional validation – matrix/specimen type robustness, agreement/sensitivity/specificity with respect to clinical comparisons
- Sample and assay stability and sample handling
- Clinical studies in support of validation under CLIA, including clinical trial site outreach, IRB approvals, patient consenting and specimen collection and evaluation
3. Biomarker testing and results delivery services
Our biomarker testing and results delivery services include:
- Quality controlled and documented protocols and procedures, including end-to-end verifications
- Cloud-based HIPAA-compliant software platform for sample ordering, accessioning, testing operations and reporting
- Controlled data recording and traceable delivery
- Data contextual analysis and interpretations – including advanced bioinformatic tools and algorithm development
Why work with us?
Quality is an attitude and one of our strongest attributes in reliably delivering results for our clients. This is evidenced by our ongoing valued clients and partnerships.
Our highly experienced and integrated team has developed dozens of immuno / protein assays over the last several years, and is well-positioned to bring its expertise to bear on your research of clinical testing needs.
We pride ourselves on our careful and trusted execution of projects, striving for expedited turn-around and delivery of results subject to our stringent quality system.
ProterixBio is differentiated from most CLIA laboratories by our extensive experience adapting commercially available immunoassay reagent-systems for fit-for-purpose and clinical grade performance in target populations. As such, we offer tiger team flexibility – we excel in enabling efficient clinical grade biomarker testing across sample types and protein detection platforms. Learn more about the assays and instrumentation platforms with which we are best-positioned to assist you, although we are flexible and our expert team is constantly evaluating new platforms to incorporate into our laboratory.
ProterixBio can also be helpful in situations where longitudinal sampling is required in heterogeneous or comorbid patient populations. Learn more about our work in COPD and other chronic diseases, in which we combine multiple biomarkers in an algorithm to yield a score that associates with clinical outcomes of interest. ProterixBio collaborated with leading academic medical centers and analyzed over 1,000 COPD patient samples, accessing high quality cohorts including detailed medical history, clinical characterization and future outcomes spanning multiple years.
If you are interested in a CLIA testing partner or need to establish and run immuno / protein assays for research or clinical purposes, please contact us to learn more about our custom immuno / protein biomarker testing services.