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Assay

Promonitor® is a series of ELISA tests that allow determination of biologic drug concentration and anti-drug antibody level in serum/plasma.

Progenika has developed IVD kits for monitoring patients treated with

  • Infliximab (Remicade®, Flixabi®, Remsima® and Inflectra®)
  • Adalimumab (Humira®)
  • Etanercept (Enbrel®)
  • Rituximab (Mabthera®)
  • Golimumab (Simponi®)
  • Tocilizumab (RoActemra®)

Please go to the Order section for a detailed list of local authorized distributors in each territory.   

Progenika also offers clinical analysis testing for all the drugs and anti-drug antibodies. 

Promonitor® allows the circulating levels of each drug and any immune response triggered in the patient by the treatment to be measured extremely accurately thus allowing better clinical management of patients.

 

The Promonitor® family of tests has been developed using ELISA technology allowing rapid turn-around times for result reporting. All assays have been extensively validated following the corresponding FDA guidelines for the validation of bioanalytical methods, and the corresponding CLSI guidelines for the validation of IVD products. Testing Services are performed under GLP conditions. Kit manufacturing is performed in ISO13485 accredited facilities under GMPs.

 

Analysis Sample
 Required volume
Levels of infliximab and antibodies against infliximab

Serum

300 µl

Levels of adalimumab and antibodies against adalimumab

Serum

300 µl

Levels of etanercept and antibodies against etanercept

Serum


300 µl

Levels of rituximab and antibodies against rituximab

Serum

300 µl

Levels of golimumab and antibodies against golimumab 

Serum

300 µl

Levels of tocilizumab and antibodies against tocilizumab 

Serum

300 µl

Levels of vedolizumab and antibodies against vedolizumab 

Serum

300 µl

Levels of ustekinumab and antibodies against ustekinumab 

Serum

300 µl