Its typical of these types of organisations and its theirjob on first pass is to come back with q’s that is part of their role and gettingPBS cover is always a multi-stage process.PIQ gets their right of reply and gets to answer these queries, that’s what a consultative process is!
With regard to the queries they raised, these would bereally easy for PIQ to rebut/answer and they have no doubt already answeredthem or are in the process of answering them.
1.Therehave already been clinical utility studies in the USA which were overwhelminglypositive with doctors saying they would use the test.PIQ states they will/are doing a similar study with Aust doctors, I’d expect the Aust utility studies to yield similar results to the USA study, i.e. be positive and show that Aust doctors will want to use the test (remember PromarkerD has been shown to outperform standard of care, 5th Nov 2021)
2.Ifyou didn’t add in HDL you would get a lessor result?This query just doesn’t make sense, it obvious the combination of biomarkers work and it has been shown on ~5,000 patients to a sensitivity of 84%, which is very high and significantly better than a lot of other standard of care tests for other life-threatening diseases.
3.As forfrequency, if you were a T2 diabetic, why wouldn’t you want to be tested everyyear or more often?Why wait until year 3 and risk getting DKD or having your disease state increase?
4.As forthe PromarkerD hub algorithm being valid, it's part of the test and has beenproven and peer reviewed (including by big pharma - Janssen). This again doesn’t make sense.
One glaringly obvious point is that the PASC notedthat outcomes may improve only as a result of changes in clinical management, butthe targets and extent of this clinical management can be guided moreaccurately with a PromarkerD test. i.e. PromarkerD will be able assist clinicians more accurately manage their T2 diabetic disease state and this will result in better patient outcomes (e.g. reduced dialysis/kidney transplant risk).
(20min delay)