It's cool! How did you find this though, why no announcement. They made two announcements about that other website for direct marketing to NZ (one to tell about it and one on launch).
Printable View
Nice website, but looks like it is not quite finished at the moment. Contact form doesn't work and the Terms & Conditions page still has dummy text. http://www.bladdercancer.me/terms
Good chance to brushup on some Latin.:)
Not in full swing yet obviously, but a great way to get the message out there.
People in dire straits often turn to the net for help in finding solutions. Having the ability to consult directly online looks like being a very astute, worthwhile and caring approach.
FDA approval is not presently necessary, US clinicians understand their own health system quite intimately and understand with that knowledge what credentials are and are not required, unlike perhaps those of us in NZ who are not so familiar.
Edison perhaps summarises best everything one needs to know about Cxbladder and FDA.
Edison report: http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799
“The Cxbladder range is being developed as laboratory-developed tests (LDTs). LDTs are a class of in vitro diagnostic test manufactured, developed and validated for use in a single laboratory.
The CMS (Centers for Medicare and Medicaid Services) regulates clinical laboratories that carry out diagnostic testing through the authority of CLIA (Clinical Laboratory Improvement Amendments), which establishes quality standards for clinical lab testing and a certification programme for labs that perform testing using IVD devices. Under CLIA requirements, the analytical validity of the LDT is evaluated, whereas the FDA’s PMA requirements assess the clinical validity of a test.
The distinction is that analytical validity defines the ability of the test to detect or measure the analytes in question, whereas clinical validity is the ability to accurately diagnose or predict the risk of a particular clinical outcome.
In 2013 Pacific Edge received CLIA regulatory approval for its Hershey, PA laboratory as well as its lab in Dunedin, New Zealand. The company has also received the CAP (College of American Pathologists) signification approval in the US.
Pacific Edge management is currently exploring the pathway to full FDA approval for the Cxbladder portfolio, which would enable the company to directly market to consumers. At this stage CLIA certification is sufficient for direct selling to physicians given the tests are processed in the company’s own lab.
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.
In practice the enactment could take time. According to the framework, the new requirements for LDTs are to be phased in over several years. ‘High-risk’ LDTs would be targeted first. We expect Pacific Edge diagnostic tests, such as Cxbladderdetect, would be categorised as Class II (moderate risk). As such, review requirements for Cxbladder tests would begin after the high-risk (Class III) LDTs are completed, which is expected to take five years after the FDA finalises the guidance.
The Class II LDTs would then be reviewed sequentially over a subsequent four-year phase in period. Once reviewed, a product would likely be judged on its safety and would then be required to either follow a formal pre-market approval (PMA) registration process or an optional registration. Given the long notice period, we expect Pacific Edge will have adequate time and resources to prepare for this”
Without FDA approval physicians are unlikely to adopt any test without clinician validation, its good to see PE management seeking FDA approval for the Cxbladder portfolio.
Ummm well no, incorrect, US clinicians are smart very well educated folk who know the difference between FDA and LDT, it's as routine for them as grits and baggles. The only confusion is here in NZ, it would seem, where we struggle a bit sometimes to understand a system we are neither immersed within or familiar with.
Pacific Edge are pursing FDA approval not because they need to, but because their is concurrently a realignment of regulations that may require them to have FDA approval sometime in the future, they have plenty of time to do so, and really don't have a reason to rush into it.
you misunderstood, yes without FDA approval, a CLIA test can still be marketed, to physicians not direct to consumers, however, CLIA approved tests or any other tests are unlikely to be adopted by physicians without clinical validations (user programmes, studies, etc...). FDA approval is a more rigorous, extensive, gold standard to the adoption of any tests or products/drugs, in which clinical validations are a part of.
I don't think you've quite got it yet, FDA approval would be required if Pacific Edge had two or more laboratories within two different states as it is a federal process. FDA approval is not a gold standard, a gold standard is a colloquial term used by urologists, in this context, to describe the mutually adopted policy driven procedures for the detection of bladder cancer, the gold standard is presently cystoscopy.
FDA approval would not be difficult for Pacific Edge to obtain, they have the clinical validations they would need already and have had them for some time now. It can take a couple of years to obtain for some companies if they do not already have completed clinical trials and associated validations, Pacific Edge already have these.
Pacific Edge may pursue direct selling to patients in the US at some point, but for now there seems to be a recognition that it would not be the best use of staff and resources. The big revenues will come from establishing and rolling over user programmes with HMO's, and this is where they are, appropriately allocating resources at present.
I am unfamiliar with the requirements for obtaining FDA approval, however, what does state lines have anything to do with FDA approval? FDA approval is currently is the gold standard (in the US anyway) in the acceptance of tests and drugs.
I am uncertain how far along Pacific Edge is completing its clinical trials and obtaining the necessary validations, but here is a quick overview of the FDA approval process. http://www.fiercebiotech.com/topics/...al_process.asp
Hey Miner, MAC needs the wall. Is it free atm?
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.
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.
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):
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."
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''
OMG. Someone oughta call PEB with this info. What were they thinking?
Seriously - Guys? They got this, ok?
Its called shifting the goalposts.
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.