PIQ announces delay in commercial US launch of Promarker D. SP has had a strong run lately but it will be hit by this news. However giving a positive spin on the experience with bringing other tests to market and continuing to pursue other global markets.

Proteomics International advises that, based on its latest assessment of the necessary technical and commercial work required to launch PromarkerD in the USA, the USA launch previously planned for Q2 2024, is now likely to be delayed.

Significantly, our experience with PromarkerD has provided the Company with invaluable knowledge and experience to accelerate the commercialisation of other tests in development. To this end, the necessary technical work has already commenced to prepare for the commercialisation of PromarkerEndo, the Company’s test for endometriosis, and PromarkerEso, the Company’s test for oesophageal cancer.

The Company remains focussed on executing further licensing and distribution deals in new jurisdictions for its PromarkerD test and is currently in discussions with a number of parties.

After a long trading halt announcement finally released on reimbursement price for US of $390 for DKD test effective CY24.

Total US/Europe diabetic population of 90+million. AUS 1.5 million

Australian TGA approval knocked back on what appears to be a technicality. Data supplied was from before the manufacturing moved to Europe. It seems the company thought they could get it through but will have to complete more testing.

IP protection for PIQ spin off OxiDx. OxiDx's next generation diagnostics technology offers a comprehensive solution for monitoring oxidative stress levels using a simple fingerprick blood test. Interesting that first trials are in elite athletes and racehorses!

First of a new family of patents for the OxiDx technology has been granted in Japan

Oxidative stress has been implicated in many chronic diseases - target applications include chronic fatigue, muscular dystrophy, high-performance athletes and the horse racing industry.

Continuing to build the suite of tests

Promarker pipeline - Oesophageal cancer diagnostic test update

Proteomics International invited to present latest results on blood test for oesophageal cancer at the 19th ISDE World Congress for Esophageal Diseases in Toronto, Canada

Test targets both oesophageal adenocarcinoma and pre-malignant condition Barrett’s oesophagus

Research expanded to include a further 350 cancer samples from the Victorian Cancer Biobank

“This technology has the potential to act as a screening test for oesophageal adenocarcinoma, providing earlier diagnosis without the need for an invasive endoscopy. We believe an externally-validated test will garner significant interest, both commercially and in the clinic.”

A good week for PIQ. A trading halt pending release of agreement for US commercialisation of PromarkerD and showcasing the endometriosis blood test to the world.

Trading halt of its securities pending the release of an announcement regarding an exclusive licence agreement with Sonic Healthcare USA for the use and commercialisation of the Company’s PromarkerD test in the US market.

New diagnostic blood test showcased at world’s premier endometriosis conference

Proteomics International presents potential new blood test for endometriosis at the 15th World Congress on Endometriosis in Edinburgh, Scotland, held by the World Endometriosis Society

Test offers improved early screening for the disease, correctly identifying up to 90 per cent of patients with the condition in a study of over 900 participants

Research also suggests the current gold standard for diagnosis—an invasive surgical procedure— may be misdiagnosing some patients

PIQ test used in research that supports the argument that PromarkerD test can be used to improve treatment and outcomes in prevention of diabetic kidney disease.

Canagliflozin lowers PromarkerD diabetic kidney disease risk prediction scores

Research conducted with Janssen Research & Development looked at PromarkerD results of patients taking diabetes medication canagliflozin in those who took the medication compared to placebo.

Effect was greatest in participants predicted by PromarkerD to be at high-risk of a decline in kidney function at the start of the study

Research published as a feature article in the peer-reviewed Journal of Clinical Medicine

Study shows the power of using PromarkerD as a Precision Medicine tool to assist in the treatment and prevention of diabetic kidney disease

”it's exciting that we can identify patients who are asymptomatic for diabetic kidney disease but still at high risk of developing the disease, and that canagliflozin significantly lowers their risk of developing diabetic kidney disease . It's an elegant example of using precision medicine to enable early intervention and slow or stop the onset of disease.”

Announcement that expands PIQ / UWA collaboration into proteomics development that mentions agriculture and environment which are large potential markets. $1.7M of Commonwealth funds allocated.

Cutting-edge WA Proteomics Facility operated by Proteomics International and The University of Western Australia (UWA) receives new funding to expand precision diagnostics capability

Proteomics International and UWA in partnership with Bioplatforms Australia will invest A$2m over the next three years with Proteomics International’s contribution being $150,000.

Bioplatforms Australia (through the Commonwealth Government National Collaborative Research Infrastructure Strategy (NCRIS)) will contribute $1.7m to the Facility for capital and operational purposes, of which half the funds will be paid to Proteomics International to expand its laboratory capacity. Proteomics International and UWA will each invest a further $150,000 in cash.

Funding to help create a state-of-the-art analysis pipeline for industrial-scale screening to explore biological markers across medicine, agriculture and the environment

Dr Richard Lipscombe said “we are building on our recent successes in diagnostics development to create a state-of-the-art high-throughput analysis pipeline to address more real-world challenges in clinical and agricultural diagnostics.”

There are clinical samples sitting in biobanks and sample repositories all over Australia that can be used to help combat chronic diseases. Similarly, analysing seeds in national and international seed stores could help make breeding decisions that boost the world’s agricultural output. All these biological samples are a precious and limited resource. By analysing them faster and at greater scale we can accelerate the development of new precision diagnostic tests that could improve patient care or transform agriculture production.”

The expanded facility is expected to be fully-operational in 2023.

PIQ announcing positive results for early stage cancer test expanding the range of tests offered by the technology.

Dr Lipscombe said the next steps in commercialising the prototype test are to:

• further develop the statistical modelling to improve the test’s sensitivity and specificity. This will use the 'traffic light' system developed for the Company's PromarkerD predictive test for diabetic kidney disease;

• refine the reproducibility of the biomarker measurements to produce a test suitable for the US Laboratory Developed Test (LDT) pathway via CLIA certified clinical laboratories;

• confirm the clinical performance of the test in an additional independent patient cohort;

• conduct formal Economic Health Benefit Modelling and Clinical Utility Studies to demonstrate how the new test could significantly change doctors’ treatment decisions and improve outcomes for patients and healthcare systems.

The Company anticipates that these additional analyses will be completed in stages over the next 12 months. If successful, the outcome would be a clinically validated blood test able to offer simpler and earlier diagnosis of oesophageal adenocarcinoma and the pre-malignant sub-categories of the disease. Proteomics International believes a validated test will garner significant interest, both commercially and in the clinic.

New Promarker test for Oesophageal Cancer demonstrates strong diagnostic performance

• Prototype version of potential ground-breaking test for oesophageal cancer correctly identified up to 90 in 100 people with the disease

• Milestone a significant step in the development of a simple blood test for oesophageal cancer following the study of 300 patients across two independent clinical cohorts

• Results presented at the International Society for Diseases of the Esophagus 18th World Congress (ISDE 2022) held virtually and in Tokyo, Japan 26-28 September 2022

• Test targets both oesophageal adenocarcinoma and patients with pre-malignant condition Barrett’s oesophagus which affects 1-2% of adults and can arise from chronic acid reflux

• Current screening requires a specialist endoscopy procedure and the annual expenditure on treating oesophageal cancer in the US is $2.9 billion with a five-year survival rate <20%

@Bradbury picked it a CR leaving out retail holders. Good that funds have been raised to cover planned activities will most likely hold the SP down until significant revenue arrives.

Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ), a pioneer in predictive diagnostics, is pleased to advise that it has received firm commitments for a share placement to raise $8 million (before costs) through the issue of 9.41 million shares in the Company (the “Placement”).

The Placement was at an issue price of $0.85 per share, a discount of 11.1% to the 5 day VWAP and was heavily oversubscribed, supported by Australian-based institutions, and sophisticated and professional investors.

Funds from the Placement (after costs) will be used for:

Inventory build for the PromarkerD predictive test for diabetic kidney disease

Implement US sales and marketing for PromarkerD

Development of the PromarkerTM diagnostics pipeline

General working capital

“Proteomics International has reached a major inflexion point in its corporate development - substantial capital injection ensures our currently planned activities in these areas are fully funded, and I take this opportunity to thank existing shareholders for their continued support and to welcome new investors to the Proteomics International register.”

The shares under the Placement are expected to be issued on or around 22 August 2022 pursuant to the Company’s 15% placement capacity under Listing Rule 7.1. Tranche 1 of the Placement ($7.75m) is expected to settle on or around 19 August and, subject to shareholder approval, Proteomics International Directors Neville Gardiner, Paul House and Roger Moore will participate in Tranche 2 of the Placement (total $0.25m).

Exclusive licence with Sonic Healthcare for USA market to be finalised by end of CY. Has taken 15 months and another 2-5 months for revenue. No detail on financials just "industry-standard terms for payment for PromarkerD test reagents and describes the royalty terms on commercial sales of the test. The LOI is also subject to standard terms and conditions " Market received positively up 10% at time of writing but still down on highs.

PIQ is pleased to announce it has signed a binding and exclusive letter of intent (LOI) with Sonic Healthcare USA, Inc. (a division of Sonic Healthcare Limited; ASX: SHL) regarding entering into an exclusive licence for use of the Company's PromarkerD test for diabetic kidney disease in the United States.

The binding and exclusive LOI documents the preliminary terms and expectations for how Proteomics International and Sonic Healthcare USA will work together to bring the PromarkerD test to patients in the US (excluding Puerto Rico), and for finalising an Exclusive Licence Agreement by 31 December 2022 (which may be extended), subject to the parties formalising milestone events and timelines in relation to the commercialisation process.

Key milestones under the LOI include optimising the test for a high-throughput environment within Sonic Reference Laboratories to enable commercial sale of PromarkerD, preparing for a submission to secure a Proprietary Laboratory Analysis (PLA) reimbursement code for the PromarkerD test [ASX: 28 October 2021], and forecasting sales targets for PromarkerD in the US marketplace.

The Company anticipates each of these milestones to be completed within the next 2-5 months. The LOI also provides industry-standard terms for payment for PromarkerD test reagents and describes the royalty terms on commercial sales of the test. The LOI is also subject to standard terms and conditions (including confidentiality) and warranties typical for a document of its type.

Proteomics International Managing Director Dr Richard Lipscombe said this was a pivotal point in the global roll-out of PromarkerD. “The US is the world's premier healthcare market and we are delighted to be working with Sonic Healthcare USA, one of the world's leading diagnostic companies. It is rewarding for us to see their appreciation for what PromarkerD can offer diabetes patients. We have been working with Sonic Healthcare USA towards this goal for fifteen months, and now look forward to building upon this foundation and taking our world first predictive test for diabetic kidney disease into not only the US, but also Europe where the test already has regulatory approval.”

US Laboratory Developed Test (LDT) & Proprietary Laboratory Analyses (PLA) Reimbursement Code The PromarkerD test will be launched in the US via the LDT pathway using Sonic Healthcare USA's CLIA certified clinical laboratories. The Company will also seek a unique code for PromarkerD once the test is available in the US. New reimbursement codes are approved quarterly by the American Medical Association (AMA) and its Current Procedural Terminology (CPT) Editorial Panel, and follow assessment of the economic health benefit and clinical utility of a new test. A CPT Proprietary Laboratory Analyses (PLA) code uniquely identifies a test for the laboratory and the payors. 

Positive initial results for endometriosis test. Early days and more R&D needed but aiming to solve a significant need.

The proprietary biomarker discovery platform called Promarker, searches for protein ‘fingerprints’ in a sample.The technology is so versatile it can be used to identify fingerprints from any biological source, from wheat seeds to human serum. Other tests in development include for asthma & COPD, oesophageal cancer, diabetic retinopathy and oxidative stress.

Early version of potential world first non-invasive test for endometriosis correctly identified up to 78 in 100 people with the disease

Company to take a series of steps to further refine and validate the diagnostic results to enable the commercial and clinical development of the potential breakthrough test

“It is exciting to have a simple blood test that may be able to correctly diagnose endometriosis in 70- 80 per cent of cases. At the same time, we’re optimistic we can refine the test to further improve the sensitivity and specificity, and make it more accurate for patients.”

“Until now, the standard of care to test for endometriosis has been through an invasive surgical procedure,” he said. “The results are highly encouraging and a significant start in the development of a potential world first simple blood test, that could diagnose this disease earlier and without an invasive surgery”.

A series of diagnostic models were developed for diagnosing endometriosis, including a comparison to symptomatic controls without endometriosis as well as differentiating disease severity. These novel diagnostic tools demonstrated that the biomarkers added statistically significant (P<0.05) performance to the models, with performance for sensitivity (Sn) of 65-78% across selected categories, with specificity (Sp) of 68-86%, and Area Under the Curve (AUC) scores of 0.72 - 0.89.

Dr Lipscombe said the next steps are to:

further develop the statistical modelling to improve the tests sensitivity and specificity.

repeat the laboratory analysis to confirm and enhance the accuracy of the biomarker measurements. This process has already commenced, including the use of more sensitive analytical instruments;

explore the clinical classifications of endometriosis, which is a highly complex condition, consequently diagnostics tests that selectively target sub-categories of the disease may be more accurate and provide greater clinical utility;

to confirm the clinical performance of the test in an independent patient cohort

The Company anticipates that this additional analysis will be completed in stages over the next 2-6 months. If successful, the outcome would be a clinically validated blood test(s) able to offer simpler and earlier diagnosis of endometriosis or the disease's sub-categories. Proteomics International believes a validated test will garner significant interest, both commercially and in the clinic.

4C slight decline in revenue, acknowledging anylytical services and tax rebates are currently only income, delays to projects. Language suggests Promarker revenue still a way off. Tax rebate in H1 FY23 might avoid a raise if revenue increases but likely to have to raise in Q4 FY22?

Promarker pipeline update

Whilst significant advances in the Promarker diagnostics pipeline were achieved several projects have been delayed or are on-hold. This reflects instrument capacity constraints, in part caused by maintenance issues arising from border closures, and has also meant some datasets have not achieved levels of sensitivity that the Company desires for its development of novel diagnostics tests.

Proteomics International has instigated a number of initiatives to overcome these obstacles, which will yield improved results going forward, and looks forward to providing updates on the outcomes of these steps in due course.

Proteomics International's business model is to continue the commercialisation of PromarkerD whilst using its Promarker technology platform to create a pipeline of novel diagnostic tests, and offset the cash burn from R&D and product development through its analytical services revenue, coupled with the R&D tax incentive rebate.

Revenue & Expenditure

Proteomics International achieved receipts from customers for the June quarter of $292,000 (March quarter: $335,000) and an additional $340,000 in grants. Receipts continue to be driven by revenue from analytical services. In particular, the Company has observed a significant increase in demand for its pharmacokinetic testing services , and renewed interest in biosimilars testing.

The net operating cash outflow for the June quarter was $1.04 million (March quarter: $1.28 million).

Expenditure centred on the following areas: • Business development and commercialisation costs for the roll-out of PromarkerD Manufacturing costs for the PromarkerD immunoassay

Regulatory and reimbursement activities to support PromarkerD commercialisation

R&D for projects in the Promarker diagnostics pipeline

Cash position At 30 June 2022 the Company had cash reserves of $2.1 million (March $3.3 million). These reserves will be strengthened by a forecast R&D tax incentive rebate of circa $1.5 million to be received in the 1H FY23. The Company is confident that its diversified business model places it in a sound financial position to fund its current objectives.

PIQ looking to increase TAM (2x) by expanding European patent to include prediabetic kidney disease testing. Needs clinical studies before generating revenue.

Patent protection (valid until September 20, 2031) for Proteomics International's PromarkerD predictive test for diabetic kidney disease expanded to cover prediabetes in Europe

There are currently 537 million adults with diabetes, and an additional 541 million (10.6% of the world's adult population) with prediabetes

Diabetes is the leading cause of chronic kidney disease which affects 100 million Europeans and is estimated to cost the European health system EUR140 billion annually

Proteomics International's original European patent was restricted to diabetic kidney disease only. The new patent will now provide protection for the use of the PromarkerD test for any individuals with prediabetes, which is an at-risk category for kidney disease.

Further clinical studies are needed to demonstrate that PromarkerD can be used to diagnose kidney disease beyond those with diabetes, however, there is already evidence that the biomarkers in the PromarkerD panel are important in chronic kidney disease more broadly.

PIQ data supports expanding testing of Endometriosis biomarkers.

Dr Lipscombe said, “The statistical modelling and subsequent independent study will prove if we have a viable, novel, non-invasive test for endometriosis, and we believe this program will garner significant interest, both commercially and in the clinic”. Proteomics International has already developed PromarkerD, the world’s first predictive diagnostic test for DKD. The Company's PromarkerTM pipeline contains further research programs targeting asthma and COPD, oesophageal cancer and more.

Promarker pipeline - Endometriosis update Diagnostic readout positive: Study expanded

Panel of statistically significant biomarkers for endometriosis clinically validated using samples from 857 patients

Research could lead to the world’s first non-invasive test for endometriosis

Study in collaboration with the Royal Women’s Hospital and University of Melbourne will now be expanded to include St John of God Health Care

Results will be presented at the Fertility Society of Australia and New Zealand Annual Conference (FSANZ 2022), being held 30 July - 2 August 2022

The next phase of analysis will use the validated biomarkers to build a diagnostic model, as was performed for PromarkerD, the Company's novel diagnostic test for diabetic kidney disease (DKD). This process of statistical modelling will determine the accuracy (sensitivity and specificity) of the new test and will take approximately one month. These results will also be presented at FSANZ 2022. The Company will then seek to confirm the clinical performance of the new test in an independent patient cohort. To support this independent validation, Proteomics International also announces an additional collaboration with St John of God Health Care. The Company has signed a material transfer agreement to access approximately 250 clinical samples from the St John of God Subiaco Hospital Gynaecological Cancer Research Group that were obtained from patients with either clinicallyconfirmed endometriosis or other benign (non-cancerous) conditions. Proteomics International managing director

Dr Richard Lipscombe said, “We are excited to have passed this significant milestone on our way to developing what we hope will be the world’s first noninvasive test for endometriosis. The clinical validation results are the foundation for turning the biomarkers into a new diagnostic test for endometriosis, and then the new collaboration with St John of God Health Care enables us to take another critical step in the commercialisation path by confirming the performance of our novel test in an external patient group.” In interpreting these initial results, it is important to recognise that endometriosis is a highly complex condition with a broad spectrum of clinical indications. Consequently, endometriosis is not necessarily a simple positive versus negative test, and further work may be required to detect these subtle variations.

PIQ slowly moving towards scale manufacturing and sales

PromarkerD manufacturing tech-transfer completed - Successful production of components for over 50,000 tests

Pilot batch is a significant milestone in transfer of technology needed for large-scale global distribution

Increased production capacity will allow Proteomics International to meet anticipated demand for PromarkerD in the Northern Hemisphere

Positive Government support for Australian manufacturing. SP still dropped 5% today!

Proteomics International will receive $413,516 funding to support manufacture of the PromarkerD test for diabetic kidney disease and other diagnostic tests in Australia

Funding awarded by MTPConnect as part of the Australian Government's $45 million BioMedTech Horizons program, a Medical Research Future Fund (MRFF) initiative

Funding will be used to establish local manufacturing supply chains, quality assurance procedures and support the PromarkerD application for TGA approval

It will support future manufacture of the PromarkerD test for Australia and South-East Asia by building upon Proteomics International's specialised ISO 13485 Quality Control and Quality Assurance certification. We see enormous sales potential in this region once we complete local regulatory and reimbursement approvals.

Impressive panel for a new Clinical Advisory Board to support PromarkerD global rollout. Hopefully the Italian board member helps with the delayed European rollout. Latest Investor presentation

Proteomics International establishes world class Clinical Advisory Board

Comprises highly-respected physicians specialising in diabetes and kidney disease care from the United States, Europe and Australia

New advisory board offers doctors’ viewpoint in commercialisation of the PromarkerD blood test for the prediction of diabetic kidney disease

Doctors will ultimately order PromarkerD for diabetes patients with the advisory board able to provide specific and tailored advice from the voice of the customer perspective

PIQ makes progress in having it's diabetic kidney disease test assessed for a Medicare rebate. Submitting a full application review. Meeting to recommend, defer or reject in November to be added to the Medicare Benefit Schedule. Acceptance would commercialise the test as patients would recieve a rebate. The company has already modelled the healthcare cost savings of early diagnosis and treatment vs dialysis and transplant so inclusion should make financial sense. SP has seen significant upward movement prior to this release.

More biomarker research for airway disease which suggests that the Promarker platform could be leveraged if the kidney disease test becomes widely used,

New biomarkers highlight the power of Proteomics International’s PromarkerTM technology platform to develop novel diagnostics tests in areas of significant unmet medical need

Novel biomarkers identified for Asthma and COPD

Proof-of-concept study identifies multiple protein biomarkers with potential to test for obstructive airway disease, including asthma and COPD

Research is part of a collaboration with the Busselton Population Medical Research Institute to improve diagnosis of obstructive airway diseases

Biomarkers identified in a pilot study of 75 individuals

Proteomics International to file a new patent application for the invention covering screening, diagnostic and prognostic methods of using the airway disease biomarkers

Early stage and for a particular form of oesophageal cancer so far but expands the companies range of tests if it can be commercialised.

Unique panel of biomarkers identified for oesophageal cancer

Proteomics International has identified and validated a panel of protein biomarkers with potential to test for oesophageal adenocarcinoma, the most common oesophageal cancer

Research is part of a collaboration with QIMR Berghofer to develop a novel diagnostic test

Biomarkers validated in a study of more than 300 patients

Collaboration is part of Proteomics International’s strategy to continually expand its diagnostics portfolio in areas of significant unmet medical need

Very little cash outflow this quarter due to R&D grants, possible revenue growth in analytical services and some COVID related delays to Promarker D rollout.

R&D tax incentive and manufacturing funding: Cash reserves further strengthened by $1.2 million in research and development tax incentive and a $100,000 manufacturing voucher

Analytical Services – Outlook 2022

The Company currently anticipates growing demand for its analytical services during the course of 2022 and is looking forward to updating the market as and when agreements are entered into.

Delays to rollout

Proteomics International has been experiencing delays to its supply lines due to the variant waves of the Covid-19 pandemic. Whilst these issues are not currently material for the Company, they have delayed the ISO 13485 manufacture of the PromarkerD assay [ASX: September Quarterly] and have the potential to affect engagement with diagnostics facilities and subsequent roll-out of PromarkerD.

The Company was expecting to achieve first sales of PromarkerD in Italy during the quarter under its agreement with Medical Horizons [ASX: 16 October 2020], however, this has been delayed and the Company is now targeting first sales in Italy during the first half of CY22.

Good to see PIQ growing its revenue to support R&D costs

Proteomics International secures major contract amid strong demand for pharmacokinetic testing services

This area of contract research is a hot area globally, and is seeing lots of investment alongside mergers and acquisitions. It's exciting to see this as we pursue our strategic vision to exploit our unique capabilities across analytical services and specialised biomarker discovery.

Proteomics International awarded $409,000 pharmacokinetic testing contract with Linear Clinical Research

Agreement supports Proteomics International's integrated business model and wider strategic vision to exploit its specialised biomarker discovery and analytical services capabilities

PIQ has novel nature of Diabetic Kidney Disease test acknowledged by FDA. In advanced discussions over bringing to market as LDT (Laboratory Developed Test) prior to 12 month timescale for DeNovo approval.

 US FDA provides 513(g) response for PromarkerD

The US Food & Drug Administration (FDA) 513(g) application sought to determine the best product classification and regulatory path for PromarkerD in the USA

FDA advises that an application through the De Novo classification pathway is appropriate

The primary and immediate route to market for PromarkerD in the US remains the LDT (Laboratory Developed Test) path through CLIA (Clinical Laboratory Improvement Amendments) certified labs

 The Company considers that the De Novo classification recognises the novel attributes of PromarkerD and will have marketing advantages upon successful approval from the FDA.

The Company will now prepare a full product application to the FDA proposing the PromarkerD test system as a Class IIa IVD (In Vitro Diagnostic). It is expected the Company will submit this application in Q1 CY22, with the FDA timeline for review of such applications being approximately 12 months. The timing of the product application will enable the inclusion of Proteomics International's new ISO 13485 contract manufacturing capability [ASX: 12 August] and its Janssen Stage 2 data [ASX: 16 July].

Whilst the Company is pursuing FDA approval, the primary and immediate route to market for PromarkerD in the US remains the LDT (Laboratory Developed Test) path through CLIA (Clinical Laboratory Improvement Amendments) certified labs, which allows sales to commence prior to any FDA approval. Proteomics International is in advanced discussions with several parties regarding bringing PromarkerD to the US market.

I wasn’t aware of the difference of the FDA classification so include the info below for anyone interested.

https://kenblockconsulting.com/fda-submissions 

FDA SUBMISSIONS

Several types of premarket submissions can be made to FDA. In order to legally market a device in the US, the most common forms of premarket submissions to FDA are the 510(k) premarket notification submission and the PMA premarket approval. Another lesser known premarket submission is the de novo submission. Each of these submission types result in a determination by FDA that clears [510(k)], approves [PMA], or grants [de novo] marketing rights to the successful submitter. Other submissions to FDA include Pre-submissions (Pre-subs), Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), and Master Files, to name a few. The most commonly made submissions are described in more detail below.

510(K) SUBMISSION  

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) submission to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in part .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices (predicates) and make and support their substantial equivalency claims. Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S.

PMA

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the most stringent of the device marketing applications. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. Please note that some Class III preamendment devices may require a Class III 510(k). PMA applications will include technical sections, usually divided into non-clinical laboratory studies and clinical investigations. PMA approval typically requires a facility inspection to confirm compliance to 21 CFR 820prior to approval.

DE NOVO

The de novo pathway for device marketing rights was added to address novel devices of low to moderate risk that do not have a valid predicate device. Upon successful review of a de novo submission, FDA creates a classification for the device, a regulation if necessary, and identifies any special controls required for future premarket submissions of substantially equivalent devices. Companies with novel devices of low to moderate risk have two options when considering the de novo pathway: the company can submit a 510(k) to the FDA, and upon receipt of a “Not Substantially Equivalent” determination, the de novo request can be made; or the company can submit a de novo request without first submitting a 510(k). Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

PRE-SUBMISSIONS (PRE-SUBS)

Pre-submissions are made to the FDA in order to request FDA feedback. Pre-subs are used for various reasons including meeting requests, to study risk determination, for submission issues, and for FDA feedback to specific questions related to a pending submission or protocol. The main purpose of the Pre-Sub Program (previously known as the Pre-IDE Program) is to provide the opportunity for a sponsor to obtain FDA feedback prior to an intended submission of an IDE or marketing application. The Pre-Sub Program can also provide a mechanism for the Agency to provide advice to sponsors who are developing protocols for clinical studies for which an IDE would not be required, such as studies of non-significant risk (NSR) devices or for clinical studies conducted outside of the U.S. to support future U.S. marketing applications. Consequently, the Pre-Sub program can provide an efficient path from device concept to market while facilitating the agency’s goal of fostering the development of new medical devices. 

The share price has taken a but of a hammering of late so good to see a positive announcement on the push in to the UK market.

The distribution agreement provides medical diagnostics company Apacor Limited with the right to sell the immunoassay version of the PromarkerD test. Apacor have 25 years of experience in medical and analytical diagnostics and specialise in bringing ground-breaking technologies to their customers. Importantly, Apacor have strong relationships with government and professional healthcare bodies across the UK, which the Company expects will prove invaluable for creating greater awareness and adoption of PromarkerD.

In the United Kingdom an estimated 4.8 million people, or seven per cent of the population, live with type 2 diabetes1. The UK’s National Health Service spends at least £10 billion per year on diabetes; equivalent to 10 per cent of its budget2. Eighty per cent of the cost of diabetes is spent treating complications such as DKD. The number of people living with diabetes in the UK is expected to rise to 5.3 million by 2025.

The easy-to-use PromarkerD immunoassay platform allows hundreds of blood samples to be analysed quickly as part of a panel of routine blood tests and we expect this UK distribution deal to further drive global demand for the test,”

The term of the agreement with Apacor is for two years commences on the date PromarkerD is available on the UK market, which is conditional on product registration with the UK's Medicines and Healthcare Products Regulatory Agency (MHRA); Proteomics International anticipates completing this process within the next two months. PromarkerD is already CE Mark registered in the European Union, which will continue to be recognised in the UK until 30 June 2023, before which the Company will apply for a UK Conformity Assessed (UKCA) mark.

PIQ confirmation of the efficacy of Diabetic Kidney Disease test and plans for WA production with $100K grant.

PromarkerD significantly outperforms current standard of care tests in predicting future kidney function decline

PromarkerD correctly identified 84% of patients with normal kidney function that went on to experience kidney function decline that would be missed by standard of care tests

For patients whose kidney function did not decline PromarkerD demonstrated a higher “rule- out” rate and considerably less false positives than standard of care testing

PromarkerD predictive testing for diabetic kidney disease could reduce the risk of dialysis or kidney transplant leading to significant cost savings for healthcare systems

Critically, all of these patients would have been missed by the eGFR and ACR tests which constitute the current gold standard of care under the global KDIGO (Kidney Disease Improving Clinical Outcomes) guidelines for risk classification1. PromarkerD also identified 89% of patients with abnormal kidney function who declined further over the course of the study.

Proteomics International awarded $100,000 manufacturing funding

$100,000 funding to support manufacture of PromarkerD predictive test for diabetic kidney disease and other diagnostic tests in Western Australia

Funding will be used to establish additional ISO 13485 quality control processes for manufacture of the immunoassay version of the PromarkerD test

Awarded through the MTPConnect WA Life Sciences Innovation Hub

The $100,000 voucher will be matched dollar for dollar by the Company, with the project to be completed over a 9 month period.

PIQ shares have dropped substantially in the last couple of months. This announcement is an important step to getting US reimbursement from insurers and combined with the earlier announcement on healthcare cost savings should be the start of a significant revenue stream.

Clinical utility study demonstrates benefit of PromarkerD testing - evidence to support payor reimbursement

New study shows the PromarkerD predictive test for diabetic kidney disease significantly impacts clinical management decisions for patients with type 2 diabetes

 PromarkerD test results changed physicians’ prescribing and monitoring decisions and were more important to doctors than current standard-of-care tests

Clinical utility study to add to the weight of evidence supporting a US reimbursement code application for PromarkerD

Results presented today at the Academy of Managed Care Pharmacy (AMCP) Nexus conference

More than three-quarters of physicians reported they were very or extremely likely to use PromarkerD in the future.

This study shows PromarkerD offers a cost-effective, personalised approach to improving patient outcomes. It allows earlier targeted treatment of those patients at highest risk of diabetic kidney disease, while avoiding unnecessary interventions for people at low risk.”

Proteomics International's managing director Dr Richard Lipscombe said engaging Biotem and Abcam were key elements in achieving the Company’s goal of selling a test with full regulatory approvals at scale worldwide.
“Currently, the PromarkerD immunoassay (ELISA) kits are manufactured under licence in Australia,” he said. “Now, by contracting these specialist manufacturers we are building our production capacity to meet our anticipated demand for the test in the Northern Hemisphere and worldwide.”

Positive announcements keep coming for a test for Diabetic kidney disease with predictive abilities to save huge costs associated with dialysis by allowing earlier treatment