Fra en af BioPortos egne distributører:

Dette fra en af BioPortos egne distributører:

“From all AKI markers currently available (L-FABP, Kim-1, IL-18), NGAL is the one with highest reputation and time advantage. However, even the best biomarker depends on the realities of the national health care systems, whereof Germanies belongs to the most stringent: cut of costs (lab budget, turnaround time, staff), reduction of number of biomarkers / implementation of lean cost-effcient diagnostic pathways within QM system, evidence for cost-benefit of patient treatment, clear indication for a defined medication related to specific biomarker levels / implementation into therapie guidelines, inclusion into reimbursement catalog of health insurances, FDA approval a.o.
There is definitely a big interest of clinicians in NGAL and some substantial orders have been made for study purposes, because the clinicians want to get more evidence that the marker would meet the requirements of this cost-oriented, quality-driven regulatory framework before considering routine use.

For the time course of new biomarkers you may look at PCT. From the discovery of its usefulness until FDA approval it took around 10 years, and it took some further years after FDA approval to get it into routine.”

Vi nærmer os, spørgsmålet er om de har spillet fallit inden.”

Det er altså et langt sejt træk at få et sådan produkt udbredt, hvilket jeg nu retropektivt har en ide om at Abbott har været meget mere bevidst end vi har forestillet os. Det har for Abbott (og andre intressenter) på ingen måde været interessant nok at give Bioporto penge upfront, samt love dem en licensaftale for 5 år siden, som vi håbede på. Abbott’s test har ikke engang fået et FDA stempel endnu, på trods af at det er årevis siden de indleverede deres test til godkendelse.

Det kan ikke andet end betale sig for Abbott, (og andre) at forsøge at kværne Bioporto så længe som muligt, for at få prisen så langt ned som muligt (om nogen overhovedet).

Deciderede gamechangers vil så formentlig være: opretholdelse af cut-off patentet i EU, udstedelse af samme i USA, samt FDA godkendelse af testen. (Bioporto havde før indsendelsen af FDA ansøgningen en “home-brew” godkendelse på Mayo Clinic af deres test, hvofor at man bør kunne forvente at FDA før eller siden når frem til det samme)