Periodic Reporting for period 2 - ProSCAN (Prostate cancer diagnostics using a non-invasive test based on innovative glycan-based scanning)
Período documentado: 2022-10-01 hasta 2024-02-29
Glycanostics aim to create a world where cancer will be diagnosed early and treated successfully. Glycanostics’ test would transform the cancer diagnostics process for EU deadliest cancers including Prostate Cancer (PCa). As early diagnosis is crucial for the success of the treatment, Glycanostic’s test will save thousands of lives, improving patients' survival time and QALY (Quality-adjusted life years). Moreover, it will bring significant savings to the healthcare system.
Prostate cancer (PCa) is the 2nd most frequent cancer in men with 1.4M new annual cases and nearly 0.4M deaths worldwide in 2020. PCa incidence is expected to increase to 2.1M cases and 0.6M annual deaths by 2035. Statistically, 1 in 8 men will get PCa in their lifetime. However, nearly 50% of cancer deaths may be avoided if PCa were detected at early stages. Survival is proportional to the stage reached at the time of diagnosis - hence early-stage diagnostics is key to reduce mortality. Our aim is to clinically validate & register ProSCAN, an affordable, non-invasive next-generation liquid biopsy PCa diagnostic test with a final accuracy of up to 90%. The ProSCAN is the first test for early-stage PCa diagnostics based on glycan analysis in blood. ProSCAN will identify healthy men and those at risk of PCa, who need a confirmatory biopsy. Being so accurate, ProSCAN will eliminate ~1.6 M of avoidable biopsies with the cost of ~€1.5bn (in the EU and the US alone).
Cancer-associated changes in DNA/RNA include mutations/modifications like methylation (genomics and epigenetics), correct expression of proteins and their activity (proteomics), and availability of carbohydrate (sugar) building blocks (metabolomics) together with physiological status of the cell (activity/structure of Golgi apparatus). These changes result in changed glycosylation of proteins. Thus, analysis of modified glycan compositions integrates all these changes with a need to analyze only 1-3 glycans for reliable cancer diagnostics. Glycanostics is the only company whose molecular diagnostic tests are based on glycans analysis, using glycan-recognizing proteins (lectins). This allows the analysis of glycans on proteins without needing to release and modify them in a simple ELISA-like (ELISA = Enzyme-Linked ImmunoSorbent Assay) assay format. This innovation will revolutionize the current approach to cancer diagnostics in an increasing number of indications (currently applicable to 11 types), diagnosing various types of cancer with a simple, rapid (1.5 h), mildly-invasive blood test, not requiring specifically trained staff or costly, time- and energy- consuming equipment. This state-of-the-art project, using a biorecognition controlled at a nanoscale, has a significant market-disrupting potential through the introduction of molecular tests for the diagnostics of PCa, BCa, and LCa on a massive scale.
The clinical performance of the first PCa molecular diagnostic test was compared to the other one offered by Beckman Coulter, i.e. PHI (Prostate Health Index) test. The test is used in the USA and many other countries. A clinical validation using 140 samples showed an AUC of 0.82 significantly higher than the PHI test (Beckman Coulter) with an AUC of 0.74. Using the PCa molecular diagnostic test would help HCPs to avoid 63.5% of unnecessary biopsies, while using PHI would help avoid 33.3% of biopsies. The test is applicable for therapy monitoring, as well. The study was published in the highly-ranked journal Cancers (IF=6.126) (https://www.mdpi.com/2072-6694/12/10/2988(se abrirá en una nueva ventana)).
Prostate cancer (PCa) is the 2nd most frequent cancer in men with 1.4M new annual cases and nearly 0.4M deaths worldwide in 2020. PCa incidence is expected to increase to 2.1M cases and 0.6M annual deaths by 2035. Statistically, 1 in 8 men will get PCa in their lifetime. However, nearly 50% of cancer deaths may be avoided if PCa were detected at early stages. Survival is proportional to the stage reached at the time of diagnosis - hence early-stage diagnostics is key to reduce mortality. Our aim is to clinically validate & register ProSCAN, an affordable, non-invasive next-generation liquid biopsy PCa diagnostic test with a final accuracy of up to 90%. The ProSCAN is the first test for early-stage PCa diagnostics based on glycan analysis in blood. ProSCAN will identify healthy men and those at risk of PCa, who need a confirmatory biopsy. Being so accurate, ProSCAN will eliminate ~1.6 M of avoidable biopsies with the cost of ~€1.5bn (in the EU and the US alone).
Cancer-associated changes in DNA/RNA include mutations/modifications like methylation (genomics and epigenetics), correct expression of proteins and their activity (proteomics), and availability of carbohydrate (sugar) building blocks (metabolomics) together with physiological status of the cell (activity/structure of Golgi apparatus). These changes result in changed glycosylation of proteins. Thus, analysis of modified glycan compositions integrates all these changes with a need to analyze only 1-3 glycans for reliable cancer diagnostics. Glycanostics is the only company whose molecular diagnostic tests are based on glycans analysis, using glycan-recognizing proteins (lectins). This allows the analysis of glycans on proteins without needing to release and modify them in a simple ELISA-like (ELISA = Enzyme-Linked ImmunoSorbent Assay) assay format. This innovation will revolutionize the current approach to cancer diagnostics in an increasing number of indications (currently applicable to 11 types), diagnosing various types of cancer with a simple, rapid (1.5 h), mildly-invasive blood test, not requiring specifically trained staff or costly, time- and energy- consuming equipment. This state-of-the-art project, using a biorecognition controlled at a nanoscale, has a significant market-disrupting potential through the introduction of molecular tests for the diagnostics of PCa, BCa, and LCa on a massive scale.
The clinical performance of the first PCa molecular diagnostic test was compared to the other one offered by Beckman Coulter, i.e. PHI (Prostate Health Index) test. The test is used in the USA and many other countries. A clinical validation using 140 samples showed an AUC of 0.82 significantly higher than the PHI test (Beckman Coulter) with an AUC of 0.74. Using the PCa molecular diagnostic test would help HCPs to avoid 63.5% of unnecessary biopsies, while using PHI would help avoid 33.3% of biopsies. The test is applicable for therapy monitoring, as well. The study was published in the highly-ranked journal Cancers (IF=6.126) (https://www.mdpi.com/2072-6694/12/10/2988(se abrirá en una nueva ventana)).
The team performed in Year 1 detailed characterization of novel, de-novo made glycoprotein standard (GPS) for prostate cancer diagnostics. The assay transfer into a patented format for 2 novel biomarkers & assay performance evaluation was made. The activity was concluded and reported in a deliverable in Year 2.
Clinical validation of the ProSCAN started in the Year 1 and was concluded in Year 2 of the project. ProSCAN test outperformed tPSA and fPSA test significantly in study with 501 samples and AUC = 0.84.
Preparation of the registration dossier, CE registration and certification has strared and advanced to a mature state, however it is still on-going.
Company continued to protect its IPR assets by submitting a 5th patent application and its first patent was awarded in 5/2023.
Active in dissemination continued by the end of the project, including the pre-licensing activities leading to expressed interest of several pharma- industry companies that continue with the licensing negotiations.
Also, the project management and administration has been performed on daily basis.
Clinical validation of the ProSCAN started in the Year 1 and was concluded in Year 2 of the project. ProSCAN test outperformed tPSA and fPSA test significantly in study with 501 samples and AUC = 0.84.
Preparation of the registration dossier, CE registration and certification has strared and advanced to a mature state, however it is still on-going.
Company continued to protect its IPR assets by submitting a 5th patent application and its first patent was awarded in 5/2023.
Active in dissemination continued by the end of the project, including the pre-licensing activities leading to expressed interest of several pharma- industry companies that continue with the licensing negotiations.
Also, the project management and administration has been performed on daily basis.
De-novo made glycoprotein standard (GPS) for prostate cancer diagnostics. The following properties of GPS in detail:
- Characterisation of binding properties of GPS and its ability to work into a patented format.
- Determination of analytical assay parameters (limit of detection, calibration curve, optimal assay parameters (buffer and additives) & reproducibility) of GPS into a patented format.
- Clinical validation of the ProSCAN test called GIASAY using ~ 500 serum samples confirmed that the assay outperforms any available competing solution.
- Characterisation of binding properties of GPS and its ability to work into a patented format.
- Determination of analytical assay parameters (limit of detection, calibration curve, optimal assay parameters (buffer and additives) & reproducibility) of GPS into a patented format.
- Clinical validation of the ProSCAN test called GIASAY using ~ 500 serum samples confirmed that the assay outperforms any available competing solution.