Member Info for tecbadger

soon to be a very rich man.....

Hello again S.A.TAN

Smallpeno

Regulator it does sometimes feel like this bulletin board may be a black hole

NCYT antigen will need CE marking and then evaluation by Porton Down so its a way behind some of the candidates we currently have in the mix.

As a resident I'm not surprised. The vaccination rate here is still below 50% and adherance to distancing has never been strong. We will be lockdown city once again if this continues.

a Frank Sidebottom head will do

Choo choo muthaf*cking choo

FOFAH i reckon

Thinkin I'm as frustrated as anyone but also completely aware that endless negativity on the board benefits noone.

There are political games at play here that we have zero insight into but as a member of the molecular diagnostics Industry I am happy to see some much needed attention to the sector in this country. I'm confident that the build up of infrastructure with ODX will not be for naught.

Isnt it weird how you dont see half of these negative usernames for a while and then all of a sudden they appear together egging each other on in the worlds most miserable git competition.

God only knows what a LFT would cost in the US. Probably $3000

FFB has missed his valium again

its a post sample back study so likely not LFT

The precision oncology stuff is very exciting but wait to see if it gets through phase 1 trial first. Typically 10 percent of candidates pass the first hurdle.

Is it not important to benchmark against competitors? Some are invested in both too

Thx RegUK I knew it was something outside of CE that meant they could sell in the UK but couldn't put my finger on exactly what. Tomorrow is a new day and it certainly looks like sales orders are the only thing that will shift ODX now

The mologic test may have CE already but not necessarily MHRA approval. To be honest im a bit lost with it all could do with a clarification from RegUK is they are about.

Either way these 3rd party companies get paid a fortune to conduct regulatory submissions its shocking there was this large for a delay unless there was something fundamental missing from the technical file the developer then had to resolve.

Pretty surprised AVCT threw mologic under the bus like that also.

At this rate AVCT could have their ISO13485 QMS approved and do the work themselves before it all gets resolved.

You also have to consider that for some of the lower CT results in the PCR reference there will have been positives due to residual RNA where virus is no longer present in the sample. This will impact sensitivity estimations due to the flaw in the testing method (ps there is no better method that can be used)

Impressive results for self sampling and that's now 3 independent validations of mologic performance. The positive evidence is stacking up.