Calypte Biomedical Corp (fka CBMC)

[cal_pn]

coin,
I believe that they will apply for US FDA approval on clinical trial data which are to be collected in the USA in upcoming trials. The test will be manufactured in the US too (they have mentioned it already, haven't they?) and it will be based on the ANI technology.

They need to use the ANI format in the US (and later in Europe too) because there are a lot of patents from other companies which prevent them from using the lateral flow technology in the US (and Europe and I think Japan as well).

In China and Africa it is different because all those lateral flow technology patents have never been filed and granted in those countries. At least I checked a few in the past. So everybody can sell lateral flow technology there (other patents which may be in place are not considered here by me e.g. for markers or the like).

Cal