Technology Transfer

Growing demand for non-invasive prenatal genetic testing is driving laboratories to expand local testing capabilities and reduce reliance on external reference laboratories.

Implementing VERACITY in-house enables laboratories to:

• Expand molecular diagnostics capabilities
• Increase laboratory independence
• Improve operational control
• Maximise sequencing platform utilisation
• Build sustainable genomic testing services
• Create a foundation for future assay expansion

Our Technology Transfer provides the scientific, technical, and operational resources required to successfully establish routine in-house NIPT services.

VERACITY is built on Medicover Genetics’ proprietary Targeted Technology, designed specifically for routine clinical prenatal screening. By focusing sequencing on clinically relevant targeted genomic regions, the workflow delivers high analytical resolution while supporting efficient sequencing and standardised laboratory operations.

Combined with validated in-house bioinformatics and a reliable laboratory workflow, VERACITY provides a scalable solution for medium- and high-throughput laboratories seeking to establish or expand their in-house NIPT services.

• Proprietary targeted technology
  High read depth of clinically relevant genomic regions.
• Early prenatal screening
  Validated for testing from 9 weeks’ gestation. *
• High-resolution CNV detection
  Supports detection of validated microdeletions down to 1 Mb, including validated nested microdeletions and, where applicable, microduplications. *
• Consistent analytical threshold
  Validated 3% foetal fraction threshold across all screened conditions. *
• Validated bioinformatics
  Proprietary in-house developed bioinformatics pipeline supporting standardised and reproducible analysis.
• Flexible platform compatibility
  Validated on Illumina and Element Biosciences sequencing platforms.
• Scalable laboratory implementation
  Designed for routine clinical implementation across medium- and high-throughput laboratories with automated workflows.
• Cross-indication multiplexing
  Supports multiplex sequencing of NIPT samples alongside other Medicover Genetics’ molecular diagnostic assays, improving sequencing capacity utilisation and operational efficiency.

*According to the validated intended use of the VERACITY NIPT Solution.

The VERACITY portfolio is available under different product configurations depending on the applicable regulatory framework and market:

• VERACITY NIPT Solution, comprising the VERACITY Advanced and VERACITY Premium panels, is currently available for Research Use Only (RUO).
• VERACITY IVD Kit and VERACITY HC IVD Kit are CE-marked products under the IVDD framework.

VERACITY Advanced and VERACITY Premium are panel names associated with the RUO configuration and should not be interpreted as the registered names of the CE-marked VERACITY IVD KIT and VERACITY HC IVD Kit products.

VERACITY NIPT Solution has been validated on Illumina and Element Biosciences sequencing platforms, allowing laboratories to integrate the workflow into their existing sequencing infrastructure.

Supporting multiple sequencing platforms provides implementation flexibility while enabling laboratories to maximise existing capital investments.

VERACITY NIPT Solution Technology Transfer provides a scalable foundation for laboratories looking to expand their molecular diagnostics capabilities beyond prenatal screening.

Complementing the VERACITY NIPT Solution, TarCET Kits comprise a portfolio of CE-marked, NGS-based multi-gene assays covering a broad range of clinical applications, including reproductive health, preimplantation genetic testing (PGT), carrier screening, neonatal and postnatal disorders, hereditary cancer, cardiovascular diseases, metabolic disorders, infertility, and oncology.

Built on a universal laboratory workflow and supported by proprietary bioinformatics, TarCET Kits are designed to facilitate the multiplexing of compatible assays within the same sequencing run as the VERACITY NIPT Solution. This flexible approach enables laboratories to maximise sequencing capacity, improve instrument utilisation, and progressively expand their in-house molecular diagnostics portfolio using existing sequencing infrastructure.

Together, the VERACITY NIPT Solution and TarCET Kits provide laboratories with a scalable pathway for expanding molecular diagnostic services through a single Technology Transfer model.

Our comprehensive model provides the scientific, technical, and operational resources required to establish routine in-house NIPT testing.

Assay & workflow

• VERACITY NIPT Solution assay
• Standardised laboratory workflow
• Reagent specifications and protocols
• Quality control procedures

Bioinformatics

• Validated analysis pipeline
• Data analysis workflow
• Software implementation guidance

Documentation

• Standard operating procedures (SOPs)
• Validation protocols
• Quality and implementation documentation

Training & knowledge transfer

• Laboratory staff training
• Workflow implementation guidance
• Technical and scientific knowledge transfer
• Competency support

Deployment

• Laboratory assessment
• Implementation planning
• Supply chain guidance
• Method verification guidance
• Go-live assistance

Post-deployment support

• Ongoing technical and scientific support
• Software and bioinformatics updates
• Refresher training
• Quality assessment and performance monitoring

Regulatory & quality

• Validation guidance
• Certification un
• Quality management documentation
• Risk management recommendations
• Best practice implementation guidance
• Support for quality assurance and continuous improvement

Our structured implementation framework is designed to support a smooth transition from project planning to routine clinical testing.

1. Assessment & planning
   Evaluation of laboratory infrastructure, sequencing platforms, workflows, and implementation objectives.
2. Technology transfer
   Transfer of the assay, workflows, bioinformatics, documentation, and implementation resources.
3. Training & knowledge transfer
   Hands-on laboratory training covering workflows, bioinformatics, quality procedures, and routine operation.
4. Validation & go-live
   Support for method verification, workflow optimisation, proficiency assessment, and transition to routine clinical testing.
5. Long-term partnership
   Ongoing technical, scientific, and operational support to help laboratories optimise performance and expand their molecular diagnostics capabilities.
6. Commercialisation guidance
   Marketing and commercial insights and support.

Every laboratory has different commercial, operational, and branding objectives. The VERACITY NIPT Solution can be delivered through flexible partnership models tailored to your organisation’s strategy and market position.

Brand licensing
Leverage the strength and recognition of the VERACITY brand through a licensing model, allowing your laboratory to offer a trusted prenatal screening solution while benefiting from Medicover Genetics’ ongoing marketing and commercial support.

Private label / white label
Offer the VERACITY NIPT Solution under your organisation’s own brand, enabling a seamless integration with your existing portfolio.
Our Technology Transfer specialists will work with you to identify the partnership model that best aligns with your laboratory’s commercial and operational objectives.