Again this year BioPorto hosted its annual NGAL Distributor
Forum. Invited to the meeting were BioPorto's distributors who are
selling BioPorto's test for routine measurement of NGAL in the
hospital labs, also known as The NGAL
Test™. The agenda this year focused on the clinical use and
sales aspects of NGAL. All with the aim to provide some tools and
inspiration to help take The NGAL Test™ to the next level of
acceptance in the market.
The question most often posed by doctors, to whom NGAL is new, is how to actually interpret NGAL results or use NGAL in routine? To address this question BioPorto invited three opinion leading doctors to share their experiences of incorporating NGAL into their daily routine.
Dr. Magdalena Mokrejsova
Head of the intensive care unit, Department of Internal Medicine, Faculty Hospital Vinohrady, Prague, Czech Republic.
Dr. Andreas Peter
Head of Central Laboratory, Department of Internal Medicine, University of Tuebingen, Germany.
Dr. Konstantinos Makris
Clinical Biochemistry Department at KAT General Hospital, Athens, Greece.
Dr. Mokrejsova shared some very interesting patient case stories about how NGAL improves her patient management. Patients, who are treated with nephrotoxic antibiotics such as gentamicin, are highly prone to suffer an acute kidney injury, but monitoring NGAL levels guides her to adjust the dosage in the nick of time before the injury progresses into a potentially devastating kidney failure. Please download Dr. Mokrejsova's full presentation here.
As head of the central laboratory Dr. Peter has been deeply involved in implementation of NGAL on the Siemens ADVIA analyzer in hospital laboratory. It was very interesting to learn that NGAL had been evaluated for use in surprisingly many clinical disciplines within the hospital. The intensive care, surgery, emergency, pediatric, cardiology, gynecology, hematology and gastroenterology departments have all used NGAL. However, most of the requests for NGAL analysis come from the nephrology department that use NGAL in connection with all kidney transplantations where NGAL guided steroid treatment has helped prevent graft rejection. Based on the practical experience and use of NGAL, they are able to conclude that NGAL is a valuable tool not only to increase diagnostic accuracy but also to secure therapeutic safety in situations of deteriorated kidney function after kidney transplantation.
Dr. Makris gave a thorough summary of the potential for NGAL in clinical use and he also touched on the economic benefits of using NGAL. Studies on cost-effectiveness show that NGAL measurements will contribute towards cost-savings for hospitals when managing kidney injury patients. Working in the hospital central laboratory, Dr. Makris is well aware that economic value plays a central role when a hospital is presented with a new potential high volume test like NGAL.
Remarkably, Dr. Makris concluded by saying that while the evidence for NGAL guided treatment is still emerging, using NGAL as an exclusion parameter is a "no brainer". The negative predictive value of NGAL is unquestionable. A "low" NGAL level is valid in clinical decision making and can be used safely as a diagnostic exclusion criterion i.e. to dismiss patients.
Please download Dr. Makris' full presentation here.
BioPorto's distributors also shared their various experiences at the forum.
The NGAL Test™ distributor LabMark came to the meeting with the
long awaited news that reimbursement for NGAL will be a reality
from 2013 in the Czech Republic. Reimbursement has been debated for
the past two years by the Czech health authorities and this recent
decision makes the Czech Republic the first country in the world to
open reimbursement for NGAL.
LabMark also shared information about their excellent collaboration with Roche in Czech about promoting The NGAL Test™ together. We believe that this is a great opportunity to reach the customers of a major instrument provider.
Another distributor shared that they have won a tender for providing a high number of NGAL tests to a Clinical Research Organization (CRO) working on a clinical trial for a major pharmaceutical company. The study protocol includes the use of NGAL for toxicology evaluation. The key thing is that this protocol is approved by the FDA, hence recognizing the use of NGAL as a safety biomarker in clinical studies. The distributor is very excited because they expect similar opportunities to arise in the near future.
All in all it was delightful to experience the optimism that permeated the forum. The distributors feel that they are very close to breaking through with NGAL - in very individual ways. The numerous technical and clinical validation studies that the distributors have orchestrated in 2012 have helped pave the road to this milestone and 2013 seems promising for increase in routine users of NGAL.