Grifols (MCE: GRF) (MCE: GRF.P) (NASDAQ: GRFS), a global leader in the development of plasma-derived therapies and leader in the development of innovative diagnostic solutions, today announced it has begun European commercialization of a two-test point-of-care (POC) system for monitoring a patient’s level of infliximab, the medication that treats a variety of chronic inflammatory conditions, as well as the antibodies that could neutralize the drug’s efficacy.
The CE-marked rapid POC technologies, which belong to the Grifols family of immunoassay tests commercialized under the Promonitor Quick name, deliver results in only 20 minutes using a single finger-prick sample directly from whole blood. The tests cover both the reference infliximab (Remicade) and the infliximab biosimilars such as CT-P13 (Inflectra/Remsima), SB2 (Flixabi/Renflexis) and GP1111 (Zessly/Ixifi).
Small and portable, the PQ device lets clinicians and laboratory staff quantify levels of infliximab or detect its antibodies at any time. Results appear on a high-tech PQ reader while the patient waits; there’s no need to wait days for lab analyses. The treatment’s dosages, therefore, are more easily optimized and personalized at the moment.
“The Promonitor Quick tests for infliximab are an important advance in therapeutic drug monitoring and will greatly enhance the level of care provided to patients living with debilitating inflammatory conditions such as Crohn’s disease, ulcerative colitis and rheumatoid arthritis,” said David Dew, President, Grifols Diagnostic Commercial Division. “The solution underscores Grifols’ commitment to applying the most advanced technology to improve patients’ experiences and their satisfaction.”
PQ is based on lateral flow immunochromatography technology and doesn’t require any pre-analytical sample processing. Both POC tests for infliximab are also CE marked for serum use and venous whole blood.
Other immunoassay monitoring kits under the Promonitor name include those for adalimumab, vedolizumab, ustekinumab, golimumab, etanercept and rituximab.
Source: Company Press Release
