Unique selling points

Mosaiques' proteome analysis has achieved a unique position on the global markets in clinical applications, particularly in the areas of diagnostics, therapy evaluation and drug development. This is based on the use of valid and reproducible clinical proteomic biomarkers and a unique database.

The importance of a comprehensive protein analysis, in particular an analysis of the current entire proteome - the ‘handprint’ of the human proteome - depends crucially on the proof of medical benefit in qualified, evidence-based clinical studies.

A fundamental prerequisite for this is a method that delivers consistent results when the same body fluid sample is analysed repeatedly. Most companies offering protein analysis or proteome analysis fail to fulfil this simple requirement. Many do not even reach the point where they identify the appropriate body fluid sample - blood, urine, saliva, or bile - that should best be used to define disease by proteomic analysis.

Reputable providers of proteome analysis concentrate on analysing a small number of proteins or their fragments using established methods and do not claim to offer comprehensive clinical tests. The further a method deviates from the direct analysis of proteins in body fluids, the greater the risk of irregularities that make it impossible to reproduce the results. In studies published worldwide, urine has been identified as the most stable and informative medium because, unlike blood, it is not affected by proteolytic enzymes that break down proteins. Theranos once claimed to be able to make comprehensive diagnoses from a single drop of blood, although the limitations of blood for proteomic disease definitions were already known and published at the time.

Unfortunately, in recent years, some methods have gone public without sufficient clinical and scientific evidence, making false promises. There has been an inflationary increase in analyses of individual proteins that are falsely labelled as clinical proteome analyses. This approach is not only practised by individual companies, but also by some university departments. None of these proclaimed methods has ever demonstrated clinical benefit in published studies.

Mosaiques is the only company in the world that has proven the clinical validity of its proteome analysis in over 100 clinical studies and has more than 400 publications in high-ranking scientific journals. Together with over 1,200 renowned scientists and physicians from more than 85 university hospitals, mosaiques received a ‘Letter of Support’ from the US-FDA in 2016.

Instead, mosaiques focuses on the scientific evidence of benefit to patients, including in the context of other diseases. It is the responsibility of healthcare policy to utilise proteomic analysis for cardiovascular, renal and various cancers in order to free the population from the ‘scourge of chronic diseases’ (UN declaration).

These outstanding unique selling points of mosaiques' technology make it possible for the first time to decode the current personalised proteome and precisely define disease-specific proteome biomarkers.

None of the technologies currently available can achieve comparable results to mosaiques:

• Mosaiques analyses proteins and peptides in their unmodified form and measures their concentration directly in their original state using mass spectrometry. In contrast, other mass spectrometry techniques measure fragments, typically tryptic peptides, which are previously generated from the proteins in the sample. The amount of these peptides is used to infer the original protein present, although results may vary depending on the fragment analysed. Importantly, modifications to proteins that are critical to their function are usually not considered in these methods.
• Techniques that are not based on mass spectrometry use ‘probes’ such as antibodies or aptamers that bind a certain protein more or less specifically. The concentration of the protein is then deduced from the quantity of bound molecules. However, these methods do not provide any information about post-translational modifications of the protein. In addition, it often remains unclear whether the target protein was actually bound or another, similar protein. This uncertainty could also explain why, when analysing the same sample with different methods, such as those of SomaScan and Olink, often no consistent results are obtained, although theoretically identical results would be expected.
• The validity of the mosaiques technology has been proven in over 100 studies and more than 400 scientific publications. This includes the reproducibility of sample preparation as well as the analytical platform and data evaluation. Only on this solid basis can data from samples measured 20 years ago be easily compared with current data. This exceptional robustness of the mosaiques technology, which has led to the ‘Letter of Support’ from the US-FDA, is an outstanding unique selling point. This robust and reproducible technology makes it possible to precisely analyse, collect and compare individual proteome data. This allows changes in the proteome to be recognised, for example: a. over time, b. under the influence of therapies, or c. due to lifestyle factors. The valid analysis of a patient's specific proteome is the basis for determining the ‘effective’ drug on the basis of the identified target proteins. If the patient's disease-specific proteome shows deviating proteins, the patient must be administered other drugs or several drugs that target these proteins.
• A further major advantage of the mosaiques technology is the fact that information on multiple diseases can be extracted from the same sample and dataset. This is possible due to the huge information content, on several thousand peptides in proteins in the individual sample. One sample/dataset can be investigated simultaneously for e.g. kidney disease, cardiovascular disease, and several different tumors. No further sampling is required.

What sets mosaiques and its subsidiaries, protexam and xken-health,

apart from other providers?

1. Mosaiques has comprehensively and accurately mapped the urine proteome, with over 24,000 precisely defined proteins and peptides that can be detected in a sample. This is only possible thanks to mosaiques' unique database, which comprises over 85,000 data sets and has been growing continuously for over 20 years. No other provider has a comparable database or detailed knowledge of urine peptides and proteins, let alone their distribution. In addition, non-mass spectrometry-based techniques are generally not applicable to urine, as this medium contains various interfering factors that impair the analytical platforms. This is a crucial factor in the search for potential drugs, which can now be identified in a short time using AI, but require an extremely precise and clinically validated biomarker.
2. Mosaiques and its sales companies protexam and xken-health offer far more than just the simple measurement of proteins and peptides in urine. They do not leave doctors and patients alone with isolated values and the task of their own interpretation. Instead, they determine the respective disease with a high degree of accuracy in terms of sensitivity and specificity on the basis of extensive clinical studies - a procedure that is also required for marketing authorisations. In contrast, other diagnostic companies only provide a list of the proteins measured, the validity and accuracy of which is not proven by their own studies. This information is not sufficient to make a clinically relevant diagnosis that meets the current standards of evidence-based medicine, even for experienced doctors or specialists.
3. Mosaiques identifies which proteins and peptides in urine show significant changes in certain diseases and combines all these changes into a classification factor. This is made possible by the use of AI and specially developed algorithms that perform mathematical operations in the high-dimensional data space. These classification factors are usually based on several hundred different proteins, whose individual distribution in each sample is analysed and combined using the proprietary algorithms. To achieve this, a comprehensive database and in-depth knowledge of disease-specific changes are required. The latter can only be determined with high reliability on the basis of thousands of measurements using a reproducible and stable technology such as mosaiques.
4. The extensive knowledge from the mosaiques database makes it possible to identify specific disease-associated changes and recognise their connection with the severity of the disease, disease progression and the influence of various therapies. This makes it possible for the first time to analyse several diseases and their associated comorbidities simultaneously. In addition, the prognosis of disease development and the prediction of therapy response can be precisely defined.
5. Mosaiques does not offer a ‘simple proteome analysis’, but a comprehensive determination of specific disease markers. This differs fundamentally from the business models of other companies in the field of proteome analysis, whose technologies are often not capable of enabling such in-depth and specific analyses.

• Mosaiques has achieved outstanding data and study results with its patented proteome analysis technology and its in-vitro diagnostic (IVD) tests have been approved in Germany and Europe.

• Based on the technology and the comprehensive proteome database, which includes disease progression in the proteome and clinical findings, the response to drug therapies can be predicted ‘in silico’. No other company in the world offers a comparable service.

• The specific mechanisms of action of existing drugs are clarified on the basis of the database and the knowledge gained from it. This information is used in particular to develop new active substances based on the defined molecular pathology. This will revolutionise drug development, making it more targeted, less risky and more cost-efficient.

Mosaiques has applied its findings and disease-specific classifiers in blinded, prospective, multi-centre clinical trials and demonstrated their validity as well as the diagnostic and prognostic value of the proteome biomarkers detected. To date, no other company in the world has achieved comparable results and demonstrated them in clinical studies.