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Hiantis

A Software Revolutionizing Molecular Diagnostics

Hiantis

A Software Revolutionizing Molecular Diagnostics

A Teoresi Group project
Project

The project, now completed on the HiFuture side, aimed to develop a fast software solution for interpreting and managing the results of gene amplification for the papillomavirus. This was achieved using two innovative kits (HPV OncoPredict SCR and QT), which are based on the use of multi-parametric and combined Real-Time PCR technology. These kits allow for qualitative or quantitative, genotype-specific typing of 13 or 12 oncogenic HPV genotypes, as part of cervical cancer screening and follow-up. The kits operate on two analysis levels (screening and typing), for both manual and automated use with varying sample sizes. For these reasons, the client requested the development of software that is flexible in terms of input raw data format and capable of automated analysis. 

Client
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Industries
Scenario

Molecular diagnostics enable accurate and rapid identification of pathogens, as seen in the case of COVID and cervical infections caused by papillomavirus. Today, in screening programs for early and preventive diagnosis of cervical cancer, cytological analysis (Pap test) is increasingly being replaced by the analysis of clinical samples through the amplification of viral genetic material via PCR, as it is more objective and operator independent.  

The results, which can be obtained through a combined and sophisticated analysis in terms of reading and interpretation, typically require a high level of operator specialization. The analysis of these multiparametric and quantitative molecular diagnostics results, often involving large sample sizes, greatly benefits from the presence of software that automates the reading, interpretation, and reporting process. 

Challenges

During the project, HiFuture focused on addressing the following challenges:

  • Integration of the new diagnostic software into the usage process of two innovative analysis kits, with the need to initiate diagnostic protocols across multiple options. 
  • Validation and training of the Machine Learning model, with particular attention to the software’s flexibility, while maintaining a focus on future developments. These could include new challenges and advancements, such as the addition of further virus types and data from different instruments. The software structure and methodologies developed for HPV can be adapted with minimal modifications to diagnose other viral infections by training new models and generating updated reports. 
  • Integration of modularity and interconnectivity features into the software to ensure and enable easy integration of communication modules with the machines used. 
  • Complete automation of the analytical module’s integration into the automated diagnostic workflow, which is currently still partially manual. 
Our added Value

The software, developed by HiFuture for Hiantis, allows the parallel processing of clinical sample results and delivers infection and carcinoma risk diagnoses within minutes. The diagnoses are based on a Machine Learning model that has been validated and trained on data manually analyzed by specialists in certified clinical studies. The modularity of the software enables the integration of additional models for different viral pathologies alongside the current papillomavirus model. 

HiFuture’s expertise in the design and development process, following biomedical industry regulations, ensured the creation of all necessary documentation for inclusion in the device’s technical dossier, intending to secure its IVDD certification.

 
Results

The project has achieved the expected results, and the software has been CE-IVD certified. It has been validated against the manual quantitative reading method used as the gold standard and is now undergoing continuous validation by the client. 

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