At APIS Assay Technologies we combine expertise in Molecular Diagnostic (MDx) Assay Development & Bioinformatics, machine learning and Software Development, with insights from academia and the priorities of global clinicians and health service providers. APIS is a disease and platform-agnostic company that provide bespoke solutions to our client’s Assay Development and Bioinformatics & Software Development RFIs.

The three main workstreams of our business are:

1. Contract Development of novel Molecular Diagnostic (MDx) Assay Development on medical diagnostic platforms.

- Operating under an ISO 13485 QMS and supported by the necessary clinical & compliance teams we have expertise in developing NGS, PCR (RT-qPCR, qPCR, dPCR) and ELISA & ELONA IVD tests. Our onsite microbiology facilities mean we have the capabilities to develop infectious disease diagnostic tests in-house.

- APIS offers complete end-to-end contract development solutions covering the entire development pipeline including prototype, pilot and commercial lot manufacturing. This also includes expertise in designing, managing, and documenting global infectious disease Clinical Performance studies under CE-IVDR, UKCA and FDA (510K) requirements.

2. Bioinformatics & Biodata Engineering, ML, AI and Software Development Solutions

- Bespoke NGS Bioinformatic Pipeline development in Nextflow & CWL (RNAseq – sc & bulk; WGS; WES; proteomics)
- Experts in Single Cell Omics: data processing, analysis & visualisation
- Multi-OMICs data analysis platform development
- Biomarker Discovery (Biostatistics, ML and AI)
- In silico R&D and bespoke visualisation tools
- Clinical Diagnostic consensus variant and copy number calling algorithms and reports
- in silico retrospective clinical trial simulations utilising RWD/E for novel cohort stratification
- Gene & Cell therapy vector integration (VISA) pipeline development (CAR T)

3. Biomarker Industrial Research and Development applied to diagnostic assays, targeting oncology, inflammatory, cardiovascular, infectious disease and inherited disease areas.