With Trinity Bio Meritas Troponin FDA Trials being temporarily suspended last week (this benchtop device was discussed previously).. and due to only be now lodged to FDA in AUG 2015.. our GHC is now in an even better position to cement its place in the Troponin space... (Note that Trinity device is not handheld and can only give results in 15 mins for Troponin so not in the same league as imo).. another thing to note is that FDA trials will re-start in Feb and they expect lodgement in AUG around 6 months.. GHC trials i imagine will be similar in length ... another point is how easily things can go wrong even with non-drug trials when a third party is involved and imo they will be lucky to be given FDA approval if they could not even implement sufficient QC for the initial clinical trials that should have picked up a change in their raw materials for such an important test where life and death is at stake.. every batch received should have been tested for consistency or changes. Im surprised they did not change suppliers to be honest.. how do you ever trust that your supplier will not do the same in the future? had this change occured after product launch it had the potential to cripple Trinity severely..
"Cardiac Update
Today Trinity Biotech is announcing that it is temporarily suspending enrolment into its Troponin
clinical trials. The reason for this temporary suspension is that in the past number of days, the company
became aware of increased scatter (higher CV’s) in whole blood data. Immediately, an investigation
was initiated to determine the cause. The failure has now been positively identified as being attributable
to a format change in a chemical raw material which is purchased from a third party supplier. This
change caused instability in the product’s performance, which only became apparent over a period of
time.
The offending version of the chemical was first introduced into manufacturing during the week of July
14, 2014. All clinical trial sites which have received batches of product manufactured since that date
have been instructed to discontinue their use. Any clinical data generated using the impacted batches
has now been identified and will be excluded from the clinical trial. Trial sites which did not receive the
problem batches continue to recruit patients, although these sites will run out of product shortly.
Meanwhile, having identified the source of the problem, we have now manufactured a pilot batch of
product using the original format of the chemical. This pilot batch demonstrates performance
characteristics identical to product batches previously made and successfully used in our CE marking
trials and in the independent USA study presented at AACC last July. The supplier has now committed
to supplying new batches of the chemical in its original format. This material will be received in four
weeks time, upon which, new batches of the Meritas Troponin product will be manufactured. The
production cycle for the new batches will then take eight weeks to complete.
Enrolment to the trials will then recommence in mid-February, 2015. The clinical trials will be
conducted at multiple US hospital sites during the months of February, March, April and May. Data compilation and cardiologist adjudication will be completed during the months of June and July and it
is anticipated that a final submission will be made in August, 2015. We confidently believe that the
product will receive FDA clearance thereafter. "
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