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APIS Assay Technologies Ltd

Second Floor Citylabs 1.0 Nelson Street Manchester, Greater Manchester, M13 9NQ United KingdomAPIS designs, manufactures, and sells innovative Drug-Linked biomarker assays that improve patient outcomes across a wide range of disease areas. APIS has a strong focus in oncogenomics and pharmacogenomics (PGx) and leverages systems biology, interrogation of multi-OMICs biodata, and deployment of innovative ‘Clickmer’ ligand binding technology, to translate Drug-Linked biomarkers into clinical utility. APIS has deep expertise and capabilities in IVD development of molecular & immune assays for ultimate product realisation as diagnostic tests. In addition, APIS' expertise in bioinformatics and software development is offered as an agile service to our clients, to develop bespoke, end-to-end multi-OMICs solutions and platform development. The three main service workstreams of our business are: 1. 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) 2. Clickmers - next-generation antibody analogue tools that enable researchers to overcome the limitations of antibody-based technology. - We can develop selective research tools that can be applied to multiple applications including: - IHC, flow cytometry, ELISA, biosensor, PET imaging - Targeted therapeutic delivery and therapeutics - Bioprocessing, purification and pulldown - Target types can include protein, small molecule, cells, tissue, viral vectors, virus and bacteria. - We can also include full assay development, should this be required. 3. 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.

APIS Assay Technologies Ltd

Karnedzijeva 3/2 Belgrade, Serbia, 11060 SerbiaAPIS designs, manufactures, and sells innovative Drug-Linked biomarker assays that improve patient outcomes across a wide range of disease areas. APIS has a strong focus in oncogenomics and pharmacogenomics (PGx) and leverages systems biology, interrogation of multi-OMICs biodata, and deployment of innovative ‘Clickmer’ ligand binding technology, to translate Drug-Linked biomarkers into clinical utility. APIS has deep expertise and capabilities in IVD development of molecular & immune assays for ultimate product realisation as diagnostic tests. In addition, APIS' expertise in bioinformatics and software development is offered as an agile service to our clients, to develop bespoke, end-to-end multi-OMICs solutions and platform development. The three main service workstreams of our business are: 1. 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) 2. Clickmers - next-generation antibody analogue tools that enable researchers to overcome the limitations of antibody-based technology. - We can develop selective research tools that can be applied to multiple applications including: - IHC, flow cytometry, ELISA, biosensor, PET imaging - Targeted therapeutic delivery and therapeutics - Bioprocessing, purification and pulldown - Target types can include protein, small molecule, cells, tissue, viral vectors, virus and bacteria. - We can also include full assay development, should this be required. 3. 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.