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Asset Brief

PromarkerD

PIQ·Proteomics International Laboratories Ltd·Diabetic kidney disease in people with type 2 diabetes·Approved·[ TODO: fill in ]

Plain-language Brief

The trial in plain terms

The disease: Diabetic kidney disease (DKD) is a complication of type 2 diabetes in which sustained high blood sugar damages the kidneys over time, progressively reducing their ability to filter waste from the blood. It is the leading cause of chronic kidney disease and kidney failure in developed countries. Many patients with DKD do not show symptoms until the disease is well advanced, making early identification difficult with standard clinical tests alone. Current standard-of-care monitoring relies on measuring urine albumin and estimated glomerular filtration rate (eGFR), which can miss early-stage or normoalbuminuric DKD.
What the asset is trying to do: PromarkerD is a blood-based diagnostic test designed to predict the risk of kidney function decline in people with type 2 diabetes before significant damage is detectable by conventional markers. It analyses a panel of proteins in a patient's blood sample using mass spectrometry-based proteomics to generate a risk score. Unlike urine albumin or eGFR tests, PromarkerD is designed to identify patients at risk of progression who may appear low-risk on standard measures. The specific protein targets used in the panel are .
What the trial is measuring, and why it matters: As a diagnostic device rather than a therapeutic, PromarkerD is evaluated on its ability to correctly classify patients according to their risk of kidney function decline, typically assessed against outcomes such as a defined fall in eGFR over a follow-up period. Key performance metrics for diagnostic tests of this type include sensitivity, specificity, and area under the receiver operating characteristic curve (AUC-ROC). Analytical validation and clinical utility studies assess whether the test result adds meaningful information beyond standard clinical variables. details on the specific validation studies underpinning regulatory clearance.
Efficacy benchmarks in this setting: Standard monitoring using urine albumin-to-creatinine ratio and eGFR has well-documented limitations in predicting DKD progression; a proportion of patients with normal albumin levels nonetheless experience rapid eGFR decline (per KDIGO 2022 Clinical Practice Guideline for Diabetes Management in CKD). In terms of established therapeutic benchmarks in this setting, finerenone (Kerendia) reduced the composite kidney endpoint (sustained eGFR decline of 40% or more, kidney failure, or renal death) with a hazard ratio of 0.82 (95% CI 0.73-0.93) versus placebo in the FIDELIO-DKD trial (Bakris et al, NEJM 2020). These figures relate to treatment outcomes in diagnosed DKD populations and are not directly comparable to the performance metrics of a predictive diagnostic test such as PromarkerD.

Trial Design

Design summary

Phase: Approved
Design type: [ TODO: fill in ] — PromarkerD is an approved diagnostic device; a conventional interventional trial design schema does not apply. Validation study design details are [ TODO: fill in ].
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Expected readout window: [ TODO: fill in ] — PromarkerD is listed as approved; prospective clinical readout windows are not applicable in the same manner as for investigational therapeutics. Any ongoing post-market or registry study timelines are [ TODO: fill in ].

Asset Track Record

Did PIQ deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

8 July 2026regulatory decisionPromarkerEndo USPTO — US patent secured for PromarkerEndohit · positivesrc ASX ↗
21 July 2026regulatory decisionPromarkerEndo Australian commercial launchhit · positivesrc ASX ↗
30 June 2026commercial milestoneUS PromarkerD revenue ramp (CMS reimbursement live Jan 2026)overdue

Class Catalyst Calendar

What's landed, what's next for PromarkerD and peers

PromarkerD's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for PromarkerD. Showing past 6 months and next 12 months · 5 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients

Trial design comparison

How PromarkerD reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
PromarkerD	Proteomics International Laboratories Ltd	Diagnostic Device	Approved[ TODO: fill in ]	[ TODO: fill in ] — PromarkerD is an approved diagnostic device; a conventional interventional trial design schema does not apply. Validation study design details are [ TODO: fill in ].	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

18 activeexpand ›

AU
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study
Phase 4
Amsterdam UMC, location VUmc·Not yet recruiting·Primary completion 1 Sept 2024·NCT05727579
SA
Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy

Curated Commentary

Third-party coverage(none curated yet)

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External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for PromarkerD yet. Broker coverage of Proteomics International Laboratories Ltd is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did PIQ deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

8 July 2026regulatory decisionPromarkerEndo USPTO — US patent secured for PromarkerEndohit · positivesrc ASX ↗
21 July 2026regulatory decisionPromarkerEndo Australian commercial launchhit · positivesrc ASX ↗
30 June 2026commercial milestoneUS PromarkerD revenue ramp (CMS reimbursement live Jan 2026)overdue

Class Catalyst Calendar

What's landed, what's next for PromarkerD and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients

Trial design comparison

How PromarkerD reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
PromarkerD	Proteomics International Laboratories Ltd	Diagnostic Device	Approved[ TODO: fill in ]	[ TODO: fill in ] — PromarkerD is an approved diagnostic device; a conventional interventional trial design schema does not apply. Validation study design details are [ TODO: fill in ].	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

18 activeexpand ›

AU
DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study
Phase 4
Amsterdam UMC, location VUmc·Not yet recruiting·Primary completion 1 Sept 2024·NCT05727579
SA
Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy

PromarkerDn = 0

Proteomics International Laboratories Ltd·Diagnostic Device·Approved·[ TODO: fill in ]

Design: [ TODO: fill in ] — PromarkerD is an approved diagnostic device; a conventional interventional trial design schema does not apply. Validation study design details are [ TODO: fill in ].
Primary endpoint: [ TODO: fill in ]
Dosing: [ TODO: fill in ]
Eligibility: [ TODO: fill in ]

DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Studyn = —

Amsterdam UMC, location VUmc·—·Phase 4

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Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathyn = —

Sichuan Academy of Medical Sciences·—·Phase 4

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Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Studyn = —

Steno Diabetes Center Copenhagen·—·Phase 4

Design: —
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Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.n = —

University of Aarhus·—·Phase 4

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Mechanism of SGLT2 Inhibition in the Kidneyn = —

University of Michigan·—·Phase 4

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PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetesn = —

Brigham and Women's Hospital·—·Phase 4

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Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patientsn = —

Daewoong Pharmaceutical Co. LTD.·—·Phase 3

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"Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"n = —

Chittagong Medical College·—·Phase 3

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Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathyn = —

Second Affiliated Hospital, School of Medicine, Zhejiang University·—·PHASE2/PHASE3

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Atrasentan in Patients With Proteinuric Glomerular Diseasesn = —

Novartis Pharmaceuticals·—·Phase 2

Design: —
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Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)n = —

Shinshu University·—·Phase 2

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NAD Augmentation in Diabetes Kidney Diseasen = —

Brigham and Women's Hospital·—·Phase 2

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Renal Mechanism of SGLT2 Inhibitionn = —

University of Colorado, Denver·—·Phase 2

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Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Diseasen = —

Regeneron Pharmaceuticals·—·Phase 2

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dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluationn = —

University Medical Center Groningen·—·Phase 2

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Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoringn = —

HealthPartners Institute·—·Phase 2

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Autologous Dendritic Cell as Adjunct Therapy for Diabetic Kidney Diseasen = —

PT. JES Kasih Nusantara Sejahterah·—·PHASE1/PHASE2

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Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trialn = —

PT. Prodia Stem Cell Indonesia·—·PHASE1/PHASE2

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