Speak to our scientists to get your testing underway today. Call us directly at +1 919-381-6097 or complete this request form.
As experts in clinical assays, BioAgilytix delivers robust data sets and comprehensive data interpretation beyond what a typical diagnostic lab can offer.
We also offer the breadth of testing needed to determine disease state, characterize antibody response, and assess biomarkers related to novel viruses.
Our assays are helping the global pharma & biotech community address the immediate threats of novel viruses with new vaccine and anti-viral therapeutic programs, and also look ahead at how patients with antibodies to these viruses might impact and change clinical trial strategies moving forward.
We specialize in assays for clinical trials, so our results will stand up to stringent regulatory submission requirements.
Our Boston, MA and Durham, NC labs can perform testing under CLIA to support patient enrollment in clinical trials.
We’re able to tailor our testing strategies to your unique program, and can support development of de novo assays.
BioAgilytix uses the RT-PCR assay with Emergency Use Authorization (EUA) by the FDA to specifically detect the RNA of novel viruses to identify active or recent infections.
![pcr testing for novel viruses](/wp-content/uploads/2020/05/viral-testing-for-covid-19.jpg")
Our PCR testing can be applied under CLIA for:
— Diagnostic/ Screening Tests
— Assisting Companies in Starting & Restarting Clinical Trials
Our PCR testing offers high specificity and precise quantification, and we can provide results with speed.
BioAgilytix’s highly specific immune response assays detect IgA, IgM, and IgG antibodies to identify individuals who were infected and have already recovered from novel viruses.
The detection of antibodies against novel viruses support:
— Diagnostics
— Patient Stratification for Clinical Trials
— Immunosurveillance
— Vaccine Clinical Trials Support
Why BioAgilytix for your antibody testing needs? In addition to qualitative assessments, we are also able to provide semi-quantitative measurements (titer) to assess a patient’s relative levels (magnitude of the response) which indicate stage of infection and strength of antibody response.
Emerging data suggests that CRS in patients with severe cases of novel viruses may cause death. BioAgilytix can apply our validated MSD cytokine/chemokine panels to quantify these biomarkers in patients receiving novel therapeutics for the treatment of these viruses.
These panels have undergone full bioanalytical validation at BioAgilytix and are already utilized to support a broad range of clinical trials today.
Using our Biacore™ T200 platform, we are also able to assess immune response as well as characterize isotype switching to distinguish fresh infection from later infection and determine antibody affinities to define antibody maturation.
Biacore is available at our European lab in Hamburg, Germany and with it we are able to conduct highly specific analysis with efficient time-to-result.
We’re committed to applying our specialized expertise and proven processes to help our customers test for and understand the impacts of novel virus diseases. And with fully operational labs, we’re ready to help today.
To discuss your program requirements, contact your BioAgilytix representative or reach out to us and we’ll connect you to the appropriate scientists to get started.
US: +1 919-381-6097 | Europe: +49 40 526779 0
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