PIQ

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70.0¢ proteomics international laboratories ltd

Progress towards MSAC Review, page-2

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bella44

203 Posts.

04/05/22

22:10

Post #: 61211869

Originally posted by bigjohnny: ↑

Hi all,
In my work as a GP, information from Pharma Reps (usually new medication questionnaires or information on product listing) occasionally comes across my screen. A recent email caught my eye as it looked familiar (shown in a cut and paste below). Thought I would include it here for general information to show the wheels are continue to turn on commercialisation of PromarkerD. MSAC due to meet in Nov to consider MBS listing. Going to be an interesting 6 - 12 months IMO

Test Description:
Test X is an in vitro quantitative blood test designed to predict incident diabetic kidney disease (DKD) or progression of DKD in patients with type 2 diabetes mellitus (T2DM) before kidney damage occurs. Test X will be submitted to the Medical Services Advisory committee (MSAC) for listing consideration on the Medicare Benefits Schedule (MBS).

Test X detects three protein biomarkers (analytes) in human plasma:
Biomarker-1 Apolipoprotein A4 (ApoA4);
Biomarker-2 CD5 antigen-like (CD5L); and
Biomarker-3 Insulin growth factor binding protein 3 (IBP3).
The concentration of the biomarkers, along with clinical factors (age, HDL-cholesterol, eGFR), are entered into the Test X Hub, a proprietary software algorithm which characterises each patient as having low-risk, moderate-risk or high-risk of developing DKD (defined as eGFR below 60 mL/min/1.73m2) within the next four years or a decline in eGFR of ≥30% over four years.

Test X results are presented as a percentage risk score. The cut-offs that are used to determine the 4-year risk of developing DKD are: Test X score of <10% for low-risk, 10% to <20% as moderate-risk and ≥20% as high-risk (see Figure 1).
Figure 1. Test X risk categories for incident DKD risk within the next four years
The turnaround time for Test X may be up to 7 days.

Test Accuracy:

In validated clinical studies, Test X predicted 86% of otherwise healthy diabetics who went on to develop DKD within four years.

Test X Sensitivity: ability of the test to correctly identify those at high risk of DKD (true positive)

86%
1
Test X Specificity: ability of the test to correctly identify those at low risk of DKD (true negative)
78%
2
Negative Predicative Value (NPV): probability that a patient with a low-risk test result will not develop DKD
98%
Expand
Gr8 to see another medical professional invested !!

PIQ Price at posting: $1.03 Sentiment: Buy Disclosure: Held

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Progress towards MSAC Review, page-2

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	Test X Sensitivity: ability of the test to correctly identify those at high risk of DKD (true positive)	86%
1	Test X Specificity: ability of the test to correctly identify those at low risk of DKD (true negative)	78%
2	Negative Predicative Value (NPV): probability that a patient with a low-risk test result will not develop DKD	98%

Progress towards MSAC Review, page-2

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