LOL,Starrs, we both know NICE have given the go ahead to sell AIHL ANYWHERE , its just that as of yet no one has bought any , yes it may be because we dont have FULL approval but it can be bought, why hav nt we sold any yet ???? dont know.
The Genedrive MT-RNR1 ID Kit can be used while further evidence is generated as an option for detecting the genetic variant m.1555A>G to guide antibiotic (aminoglycoside) use and prevent hearing loss in newborns who are being considered for treatment with aminoglycosides.
1.2Healthcare professionals should tell parents about the possible implications of positive test results for their baby and their family at an appropriate time, and give support and information.
As far as I know NICE have not set a timescale on when they want the data or how much yet but it is clear this has to be rolled out wider to obtain the information to get a full recommendation and as I can't see the NHS or NICE funding it GDR may have to partially fund the cost of tests and machines to get that so that could be a way of getting funding from DEVOTE if a good enough case is put forward. We have also seen the share price jump up 20-30 percent on nothing so who knows what will happen this month, I don't for sure.
Cant disagree with any of that , site managers are treated like robots and not allowed to make decisions any more and i can only see it getting worse.
you wont get a better advert for AIHL than that you tube video, Nikki nailed it on its simplicity of use and a result in the first week . It was interesting to hear here say they are automatically using it on all admissions as well .
Hi Ben,
Wow that is a lot of men to leave in relation to a site . Do you feel that it is down to middle management not coming from a trade background as I see it more and more these days ?.
Morning Ben , I totally agree the pressure from the top is getting really bad i feel and lower management are really feeling the pressure and i cant see it letting up . I get that customers want quality for their houses and the NHBC are setting the standards but due to the lack of trades about , the quality of materials being supplied and the tight time lines something has to give . This for me is a subject that could be discussed for hours and there is no short or quick fix and with the new ombudsman quality assurance that has come out and part L i can see it only getting worse . Longer build times and better quality materials would be a start but that is only going to push up prices for already expensive houses , I dont know what the answer is but something is going to have to change and not in a good way i fear.
As AIHL is a test and not a drug therefore it is not subject to the stringent tests the FDA normally apply, its just a matter of how the FDA see the conditional reccommendation instead of a full one , we can only wait and see .
De Novo route if possible is 150 days to news once applied with the costs in tens of thousands according to FDA own site , and as we dont know what route we are going down no costs or timelines can be given apart from guesses.
Further evidence generation is recommended on:
how the test affects time to antibiotics in smaller, non-specialist centres and outside of neonatal intensive care units
how the test result affects antibiotic prescribing decisions
the failure rate of the test
the diagnostic accuracy of the test.