Flatlander schreef op 9 januari 2020 19:05:
I like tracking on a half year basis since we do not have that many data points. Either way the relative direction is the important point. This number could increase by a factor of 10 or more if the RUO designation can be replaced by clinical diagnostic approval in several world markets.
I have put up several posts that suggest that the problems in the U.S. may be more of a problem with the regulatory framework than a problem with Idylla. Unfortunately the FDA is trying to apply the medical device approval process rather than a more appropriate genomic testing standard that the Obama administration proposed over a decade ago. The FDA 510K process generally emphasizes precedents and requires the manufacturer to compare results to existing equipment already on the market. In the case of Idylla this is tough since there are no similar IVD devices to compare its results to
. Former commissioner Gotleib had changing the IVD approval process as a priority but for whatever reason, he decided to resign instead. FDA has internal guidance documents (see link below) but not comprehensive legislation from Congress. This is the reason I keep mentioning that BCART may have to be assertive to counter the lack of appropriate guidance from Congress.
Here is an overview of the FDA process that BCART has to seek approval under. www.fda.gov/medical-devices/ivd-regul...
Note that Idylla is likely bumping up against the De Novo classification (meaning no adequate precedent system exists for comparison). For this reason FDA might likely be requiring validation studies. It would seem that these are temporary hurdles, but none the less they hinder more rapid expansion of sales.