PEB - Pacific Edge Ltd

[psychic]

Hey Miner, MAC needs the wall. Is it free atm?

[MAC]

PEB completed clinical trials for Cxbladder nearly two years ago now Steve.

Once again the gold standard is cystoscopy, although if you are referring more generically to an all encompassing type of regulatory requirement, then you must note that there are several paths a company can take.

FDA approval is one such path a company like Pacific Edge could take as a molecular diagnostic test provider, another such path is achieving CLIA approval as an LDT. There are many diagnostic test companies in the US that achieve CLIA approvals for their diagnostic test products, it is not unique to Pacific Edge.

Some of Pacific Edge's competitors do require FDA approval as they have one of the following attributes, they either have laboratories in more than one state, sell directly to patients, or they offer a self home test such as NMP22 bladdercheck.

Pacific Edge do not fall into any such category requiring FDA approval, I guess it may even be that the FDA might even turn them away if they did apply simply because the FDA have better things to do then expend effort and cost on approvals that are not necessary.

Hope this helps.

[steve06]

Hi Hancocks and MAC, yes I understand clinical trials/validations such as the DHB studies currently being carried out by MidCentral DHB and user programmes are sufficient for CLIA approved tests. FDA approval would certainly be a big plus.

Will await the the results of these studies with great interest. Cheers.

[klid]

Dave says he's all about "adding meat on the bone" and I see FDA approval as doing just that, so I hope it's something they're seriously pursuing.
And the FDA were trying to extend their jurisdiction to LDTs and such a while ago if I remember correctly, so it's just another thing that could go wrong.

Get get get.

Oh I just read MACs quote of PEB referring to it (good that they did I guess):

Pacific Edge also faces the potential threat of a new regulatory hurdle in the US. On 31 July 2014 the FDA provided notice of its intent to issue draft guidance providing a risk-based framework for new regulatory requirements of LDTs such as Cxbladderdetect.

[steve06]

Haha nice one!

"the only part of the test that needs FDA approval is the collection container and instructions if it is to be used at home."

[Minerbarejet]

Hey Miner, MAC needs the wall. Is it free atm?

Sorry, havent finished repairing it. Got a headache.

[skid]

Sorry to say,the more you guys talk about this CLIA vs FDA-the more doubts arise.
Clearly the CLIA is the poor cousin to FDA approval.
They are sending out kits to customers over here so why not in the States? You guessed it-no FDA approval(yet)
Just the fact they dont have it, shows that its a ''small time,one state operation''
The fact they are going after FDA approval shows this,and thats good,but lets not kid ourselves -theres a reason they are doing this--IMO those ''clued in clinicians'' still look for that badge of honor,if for no other reason than it shows this is an outfit that is going places--that means ''states'' ,not ''state''

[psychic]

OMG. Someone oughta call PEB with this info. What were they thinking?
Seriously - Guys? They got this, ok?

[Minerbarejet]

Its called shifting the goalposts.

[MAC]

OMG. Someone oughta call PEB with this info. What were they thinking?
Seriously - Guys? They got this, ok?

Yep, well that’s the plan, get an initial 10% market share from the big professional players without needing to peddle directly with FDA paper work and an army of cheesy foot in the door sales folk.

Might be something for several years from now though, maybe if they get absolutely so much market share they may just want to mop up the rest with direct sales, probably more likely due to regulatory consolidation though.