Trinity Biotech is temporarily suspending enrollment in its Troponin clinical trials. The reason for this temporary suspension is that in the company became aware of increased scatter (higher CVs) in whole blood data.
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 that 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 that 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, Trinity has 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 the company’s CE marking trials and in the independent 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.
Enrollment to the trials will recommence in February, 2015. The clinical trials will be conducted at multiple U.S, hospital sites during February, March, April, and May. Data compilation and cardiologist adjudication will be completed during June and July, and Trinity anticipates that a final submission will be made in August 2015. Company representatives are confident the product will receive FDA clearance thereafter. Read more about the Meritas Troponin 1 point-of-care testing.Read more