[ STEP 1 ]
Scientific brief
In the first step, we analyse the application and research objectives in a structured manner to define the targets, technical constraints and operational context of the test. This phase allows us to clarify performance criteria, any design issues and possible limitations related to sensitivity or uniformity right from the start. The output is a comprehensive brief, transparent in terms of timing, design strategies and cost estimates, which becomes the basis for the OEM project.
For each project, we begin with a structured analysis of the application and research objectives. This initial stage is crucial for accurately identifying:
- which targets should be explored,
- possession or lack thereof of genomic sequences
- what technical limitations may hinder sensitivity or uniformity,
- in which context the test should be carried out.
The brief allows us to anticipate potential critical issues, define expected performance criteria and choose the most suitable design and execution strategy. In total transparency, development costs are defined and production costs are estimated, already calculated on volume brackets.
[ STEP 2 ]
Panel design and test characteristics
After defining targets and requirements, we develop the bioinformatic design of the panel, selecting optimal genomic regions and integrating internal controls when necessary. The design phase ensures sensitivity, stability and reproducibility, with test formats appropriate to the context of use. Interpretative rules and initial cost estimates for any subsequent production runs are also established at this stage.
Once the targets and requirements have been defined, if the target genomic sequences are not already available, we carry out the bioinformatic design phase of the assay.
The design phase integrates:
- selection of target genomic regions,
- optimisation of sensitivity and specificity performance,
- management of GC-rich or technically difficult regions,
- definition of any internal, endogenous or exogenous controls.
The objective is to build highly sensitive panels with stable and reproducible performance between different runs, in formats and with functionalities suited to the reference context: from the standard wet format to the dry format stable at room temperature, preloaded in PCR plates. In addition, the main rules for defining the interpretative algorithms to be integrated into the proprietary data analysis and management software are defined. Furthermore, at this stage, estimates of any costs in the event of production beyond the first batch are finalised.
Experimental validation and first production batch
In the first step, we analyse the application and research objectives in a structured manner to define the targets, technical constraints and operational context of the test. This phase allows us to clarify performance criteria, any design issues and possible limitations related to sensitivity or uniformity right from the start. The output is a comprehensive brief, transparent in terms of timing, design strategies and cost estimates, which becomes the basis for the OEM project.
For each project, we begin with a structured analysis of the application and research objectives. This initial stage is crucial for accurately identifying:
- which targets should be explored,
- possession or lack thereof of genomic sequences,
- what technical limitations may hinder sensitivity or uniformity,
- in which context the test should be carried out.
The brief allows us to anticipate potential critical issues, define expected performance criteria and choose the most suitable design and execution strategy. In total transparency, development costs are defined and production costs are estimated, already calculated on volume brackets.
OEM production and post-market surveillance
After defining targets and requirements, we develop the bioinformatic design of the panel, selecting optimal genomic regions and integrating internal controls when necessary. The design phase ensures sensitivity, stability and reproducibility, with test formats appropriate to the context of use. Interpretative rules and initial cost estimates for any subsequent production runs are also established at this stage.
The workflow of this service allows you to reach this stage with full awareness and transparency regarding production costs. Hyris is able to offer various services, ranging from OEM production to customer branding, to the management of open annual orders for flexible production over time, as well as logistics management for end users. Hyris considers industrial quality to be an essential element: the entire process is governed by ISO 9001 and 13485 standards, with no distinction between production flows in the medical and research fields. Through the innovative features of the proprietary HYRIS bAPP cloud software, customers will always have access to kit performance statistics in the field, carrying out real-time post-market surveillance or performing business intelligence analyses on activities towards their end customers.
