Hi Katy,
A great post & ANN. For IVD & PromarkerD Hub & as you said, the whole package. TGA (Australia) have approved PromarkerD Hub for export & recently I posted some new guidelines on the TGA for companion & complimentary diagnostics in Australia, which very clearly stated the would be guided by EU & USA standards (ie EMA, FDA). So maybe some news here for us soon too?
From what I understand, this test can still be carried out
by accredited labs in the USA, as Proteomics is accredited for here. I think it’s the IVD, that will be the cruncher with the FDA & with EU registration, validation & stability testing completed & very acceptable, we have reached an important milestone, not just for mass spectrometry testing now, but also for far more convenient testing for non-central labs that potentially don’t have that expensive equipment & interpretation of results online via PromarkerD Hub.
EU is moving ahead, so the wait on the USA? I still think it’s Janssen/Vifor and now with EU fast track approval of Invokana for CKD/CVD with the EMA decision due some time after the 20th of this month (150 days, a bit shorter than FDA & approval granted already), we are well set in EU. I can’t see them knocking this back after FDA approval. Mundipharma have the licence for Canafliglozin in the EU.
I don’t think this means any USA deal is away off, I still think it will depend on Janssen & the outcome of a very LONG clinical trial of analysis of trial blood samples from their CREDENCE trial & what PIQ are waiting on. This will give us massive validation & also for Janssen (J&J).
Definately a huge inflection point & proof of testing as a complimentary diagnostic in a drug class that does come with some risks. FDA are not holding up companion Dx tests, when drugs are approved.
That is due very soon, it wouldn’t surprise me if Janssen haven’t completed their end of analysis already, they have the staff & capability to do so.
With new labelling & CKD/CVD coming out for Invokana in the USA & new standard practice (including screening for CKD) in Type2 DM in Jan 2020 & USA policy on Chronic Kidney Disease (late last year) & Janssen’s announcement late last year that they will be supporting the US National Kidney Foundation in increased screening, I think we all need to watch this space.
For anyone new, all these links have been posted previously that have been mentioned above to assist you in any research.
@Eqz, the SP slide didn’t happen too long did it lol? A bit of stability. Did that big buyer get their fill? I haven’t had time to look.
Milestones!!
GLTAH
(20min delay)