Proteomics International Laboratories (ASX: PIQ) has embarked on a European commercialisation campaign following the launch of PromarkerD – its predictive diagnostic test for diabetic kidney disease – in Spain.
The Spanish launch marks the first European country where the test will be available and sets the stage for broader geographic distribution in the coming months.
The move was dubbed as a “pivotal milestone” by the medical technology company as it attempts to broaden awareness of the test and establish additional licensing transactions and jurisdictional launches.
Some potential markets already mentioned by Proteomics include 26 other European nations, Japan, India and the United States.
Proteomics said that two separates companies, Patia Europe and specialist mass spectrometry diagnostics firm Atturos, would be commercialising its revolutionary laboratory-developed test via an exclusive licence agreement signed in October last year.
Patia is a public health company operating in Spain and Mexico – integrating genomic, proteomic and metabolomic tools, with digital applications, to prevent and manage type 2 diabetes and gestational diabetes. Meanwhile, Ireland-based Atturos is a privately funded clinical diagnostics company developing and commercialising advanced molecular diagnostics solutions.
The Irish company was originally founded to commercialise the “OCProDx test” – a pioneering blood screen that can determine whether diagnosed prostate cancer is confined to the prostate or has spread beyond it.
Just yesterday, Proteomics confirmed that Atturos had successfully transferred the PromarkerD technology to its laboratories in Ireland, making it available as a mass spectrometry laboratory-developed test (MS-LDT) to licence partners in Europe.
Additionally, the technology transfer coincided with publication of the PromarkerD clinical validation study results in the Journal of Diabetes and its Complications. The results confirmed PromarkerD could “correctly predict 86% of diabetes patients who went on to develop chronic kidney disease within four years”.
This result alone is a major milestone in terms of validating the test, which could now mean widespread adoption, both by public-sector health agencies and private sector clinics.
To further extend the efficacy of PromarkerD, Atturos has undertaken a stringent validation process of the PromarkerD method and demonstrated data equivalence in 100 patient samples.
The results of this successful “cross-over” study will be presented in the ‘Precision Medicine and Clinical Proteomics’ section of the 18th Human Proteome Organisation (HUPO) World Congress to be held in Adelaide between 15-18 September 2019.
With respect to distribution in Spain, Patia Europe has an exclusive licence agreement for two years and Proteomics is set to receive royalties on each test sold.
Much like the rest of Europe, Spain is currently undergoing a diabetes epidemic with around 10% of the population affected which equates to over 3.6 million in the country.
The incidence of diabetes in Europe is increasing rapidly, in large part due to worsening lifestyle choices, poorer diets, growing consumption of artificial sugars and processed foods. In Europe overall, there are currently more than 58 million people with diabetes with that number expected to rise to 67 million by 2045.
According to scientific research, around one in three adults with diabetes will develop chronic kidney disease, but doctors are confident that early intervention could delay or prevent clinical symptoms of the disease.
As a means of combatting the growing problem of diabetes and kidney disease, the PromarkerD test is able to use a unique protein “fingerprint” that provides early detection of diabetic kidney disease, and therefore, could potentially slow the incidence of kidney disease if patients choose to be screened in large numbers.
According to Proteomics, PromarkerD is the first test able to predict the onset of diabetic kidney disease, warning of a decline in kidney function “up to four years in advance”.
“As the first country in Europe to adopt the PromarkerD test, Spain would be at the forefront of diabetic kidney disease diagnosis and prevention,” said Dr Richard Lipscombe, managing director of Proteomics International.
In parallel to its European launch, Proteomics’ PromarkerD test will also be showcased at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, taking place next week.
At the conference, Patia Europe and Proteomics International will meet with diagnostic and pharmaceutical companies as well as key opinion leaders from around the world to expand the global reach of PromarkerD and further supplement its commercial aspirations on the continent.
Furthermore, Proteomics said that the company is currently in discussions with tier-1 diagnostics and pharmaceutical companies, targeting the markets of Europe, Japan, India and the US, to expand the global reach of PromarkerD.
The commercial distributor, Patia Europe, declared that Proteomics’ “world-first technology” will allow doctors to intervene early and prescribe treatments to prevent patients from developing diabetic kidney disease.
“It’s a huge step towards addressing one of the costliest complications of the diabetes crisis,” said Dr Laureano Simon, chief executive officer of Patia Europe.
News of the Spanish launch boosted Proteomics shares by almost 12%, up to $0.335 per share this morning.