Until now during the course of biologics therapy it was difficult or even impossible to reliably measure the harmful free target molecule after the initial administration of medication, and so these treatments could not be individually dosed.
recoveryELISA® fills this diagnostic gap and can help to monitor the effectiveness of a drug dose and the effect of its variation and the formation of anti-drug antibodies, identify the non-responder, or to verify whether the therapeutic objective has been achieved.
recoveryELISA® also supports dose finding studies, pharmacokinetic and pharmacodynamic (pk/pd) studies, or personalized medicine as well as preclinical drug development and drug design.
recoveryELISA® is the ideal diagnostic tool for therapeutic antibody development, for the design of antibodies and comparable biologics, or for detecting subgroups with therapeutic failures or therapeutic successes.
We will gladly set up a specific diagnostic for you on the basis of recoveryELISA® technology for your biologic and its target molecule.
The patented recoveryELISA® principle allows to measure full antibody antigen interaction / drug efficiency simply by spiking samples only with antigen. Further, the recoveryELISA® technology measures the concentration of the therapeutic antibody without an anti-drug antibody. This makes the recoveryELISA® so easy!
New engineered or designed drug molecules such as antibodies open the gate to treat diseases specific and efficient and new research results uncover biological functions, but the usefulness of a therapy is always depending on the optimal dose of any one of the components administered.
The use of diagnostics during therapy is the key to individualized or personalized medicine, because many factors influence the effectiveness of administered drugs and diagnostics make it possible to explore these differences in individual patients.
Therapeutic drug monitoring helps in determining what interactions of the administered medications are taking place in the individual patient and whether the dose of the active ingredient has been optimally selected.
BioTeZ has developed patented recoveryELISA® to provide an easy-to-use companion diagnostic tool for the analysis of the interactions between the biologic and its target molecule, where the core of these diagnostics is the level of the free target molecule and the degree of target molecule neutralization. WATCH THE TUTORIAL
A. Measuring parallel 3 results
- Level of the free Antigen
- Level of the therapeutic antibody
- Neutralization rate of the target molecule / antigen
B. Providing the exact interaction function for the biological drug and its target molecule: the recovery curve.
The recovery curve shows the degree of antigen neutralization for each drug level in the range of measurement. The recovery curve allows prediction the effects of dose variations.
C. Indirect detection of Anti-Drug-Antibodies (ADA’s)
recoveryELISA® opens up a whole range of strategic options to you, e.g. a non-exclusive license to use it as a purely internal tool or as a companion diagnostic test kit for the appropriate dosage of your medication. BioTeZ offers the manufacture of test kits or test kit components or the analysis of serum samples with recoveryELISA®. Especially given high competitive pressure, a tailor-made diagnostic can provide a competitive edge in positioning a drug on the market.
We offer the recoveryELISA® for the following applications:
recoveryELISA® for Infliximab / TNFa Datasheet
recoveryELISA® for Evolocumab /PCSK9 More Details
The recoveryELISA® can be customized for any therapeutic antibody and antigen. We would be happy to assist you with our Technologies.
Clarification: Despite the general intention to personalize medicine by means of recoveryELISA®, that does not mean that each recoveryELISA® test kit is determined and approved for the adjustment of the active ingredient dose. recoveryELISA® test kits only deliver a recommendation for dose adjustments or for the administration or withholding of medication, when it is explicitly stated as the intended use in the instructions.