Ann: Proteomics International seeks FDA approval for PromarkerD, page-21

Good things happening for us!

For anyone looking at FDA approval process, why we are going pre-sub & best route to FDA clearance, this is a great website to explain things:

https://www.greenlight.guru/blog/de-novo-pathway-medical-device-companies

As Richard stated also, the pre-submission may assist in speeding things along with the application process.

Comments regarding advanced discussions with multiple laboratories in regards to laboratory developed Promarker D test (LDT) which can be utilised prior to FDA approval for the IVD test kit (under CLIA), as a parallel commercialisation pathway were also interesting.

That could happen prior to FDA approval, as there is the need for it especially now, as was discussed in the ANN.

GLTAH