Apis Assay Technologies

What Apis Assay Technologies does

APIS Assay Technologies Ltd is a privately held molecular diagnostics company founded in 2018 and headquartered at Citylabs 1.0 in Manchester, United Kingdom. The company designs, develops, manufactures, and distributes in vitro molecular diagnostic assays and associated software for the detection of biomarkers linked to cancer, infectious disease, and pharmacogenomic applications, operating under ISO 13485:2016 certification. Its proprietary Clickmer® chemically modified aptamer platform provides a synthetic alternative to antibodies, supporting custom aptamer development alongside a catalog of oncology (Breast Cancer Subtyping, ESR1 qPCR/dPCR, PIK3CA qPCR, MET Alterations), pharmacogenomics (DPYD qPCR and DPYD HT qPCR Kits, the latter with FDA Breakthrough Device Designation in October 2025), and infectious disease products, complemented by an AI/ML-powered target discovery platform (APIS Target Triage) and multi-OMICs bioinformatics pipelines.

The company operates a multi-revenue-stream business model combining product sales (RUO and UKCA-marked IVD kits sold direct and via channel partners), contract assay development and IVD regulatory services, bioinformatics and software development services (Biodata Insight Suite / BIOX), and Clickmer licensing and co-development arrangements. Go-to-market combines direct enterprise sales with a global distribution network anchored by Biocartis (Europe, USA, and global sub-distribution) plus regional partners across Asia Pacific, Eastern Europe, the Middle East, Africa, and South America, supplemented by conference presence, educational webinars, and scientific publication activity. Customer segments include diagnostics companies and IVD developers, biotechnology companies, pharmaceutical companies, and research institutions and clinical laboratories.

The company is led by a team with more than 100 years of combined experience from leading diagnostic companies and clinical laboratories, and operates with no disclosed external parent company, public listing, or institutional venture capital funding to date, having financed growth primarily through grant funding (Innovate UK DEVOTE programme, Innovate UK DPYD support, and prior EU funding routed through related entity Clickmer® Systems GmbH) and commercial operations.

Name

Apis Assay Technologies

Legal name

APIS Assay Technologies Ltd

Website

https://apisassay.com

Company type

Private

Founded year

2018

Operating status

Operating

Short description

APIS Assay Technologies is a UK-based molecular diagnostics company developing Clickmer® aptamer-based IVD assays (oncology, pharmacogenomics, infectious disease), contract assay development services, and AI-driven bioinformatics for diagnostics, biotech, and pharma customers worldwide.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO)

Keywords

• Molecular diagnostic assays
• Pharmacogenomic testing
• Aptamer development services
• Bioinformatics software solutions
• IVD contract development

Headquarters

HQ city

Manchester

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Diagnostic Product Sales: Sale of proprietary molecular diagnostic kits including Breast Cancer Subtyping Kit, ESR1 qPCR/dPCR Kits, PIK3CA qPCR Kit, MET Alterations Kit, DPYD HT qPCR Kit, Clickmer-based ELISA kits (TBEV NS1, SARS-CoV-2 IgG). Products sold as RUO (Research Use Only) or UKCA-marked IVD in specific territories. Distributed directly by APIS or through channel partners.
2. Contract Development Services: End-to-end assay development services from feasibility through product registration. Includes custom multiplex PCR assay development (RT-qPCR, qPCR, digital PCR, NGS, ELISA), clinical compliance services (CE-IVDR, UKCA, FDA submissions), and manufacturing services (prototyping, pilot, commercial batches). Billed per project/service agreement.
3. Bioinformatics & Software Development Services: Bespoke bioinformatics R&D services, data science, and software development solutions. Includes pipeline development, multi-OMICs analysis, AI/ML integration, cloud platform development. Billed per project, FTE flexibility, or service agreement under multi-year Master Service Agreements.
4. Clickmer Technology Licensing & Development: Custom Clickmer aptamer development services for therapeutic candidates, research tools, and diagnostic assays. Clickmers can be licensed or developed collaboratively for specific applications in bioprocessing, therapeutics, and diagnostics.
5. APIS Target Triage (ATT) Product: Automated target discovery product/subscription service leveraging AI and LLMs for biomarker validation. Catalogue number 02601, available upon request pricing.

Pricing tiers

Go-to-market motion3 records

Distribution channels8 records

Marketing channels8 records

Core offering

APIS Assay Technologies designs, develops, manufactures, and distributes proprietary molecular diagnostic test kits based on qPCR, digital PCR, and RT-qPCR technologies for oncology, pharmacogenomics, and infectious disease applications. The company also provides custom Clickmer chemically modified aptamer development, contract IVD assay development and manufacturing services, and AI/ML-powered bioinformatics and data science solutions for biomarker and drug target discovery.

Differentiator

Problem solved

Functional benefit

Brands

• Biodata Insight Suite: Bioinformatics, Data Science and Software Development solutions offered by APIS
• Clickmer
• APIS Target Triage (ATT)
• BioX

Products and services

• APIS ESR1 qPCR Kit A real-time qualitative PCR test that detects 11 key mutations in the ESR1 (oestrogen receptor) gene at ≤0.5% minor allele frequency. Instrument agnostic, compatible with most real-time PCR instruments, and used by oncology and diagnostic laboratories for breast cancer liquid biopsy and tissue testing.
• APIS ESR1 dPCR Kit A digital PCR assay detecting 11 ESR1 mutations at ≤0.1% MAF sensitivity with no observed wild-type detection. Compatible with most digital PCR systems and intended for highly sensitive liquid biopsy oncology testing in research and clinical laboratories.
• APIS PIK3CA qPCR Kit A real-time qualitative PCR test detecting the five most prevalent PIK3CA activating mutations at ≤0.5% MAF using PCR clamp and blocker technology. Works with FFPE tumour tissue (gDNA) or plasma (cfDNA), used for oncology companion diagnostic and research applications.
• APIS Breast Cancer Subtyping Kit A UKCA-marked RT-qPCR IVD assay detecting HER2, ER, PR, and Ki67 mRNA expression from FFPE or core needle biopsy breast tumour tissue. Provides results in under 5 hours for 10 samples with automated results interpretation via APIS software.
• APIS MET Alterations Kit An RT-qPCR assay simultaneously detecting MET exon 14 skipping mutation and MET gene overexpression from FFPE NSCLC tissue or liquid biopsy (cfRNA). Limit of detection at 25 copies (1.17% MAF) for METΔex14, intended for non-small cell lung cancer testing.
• APIS DPYD HT qPCR Kit

Quantifiable outcome

• FDA Breakthrough Device Designation for DPYD HT qPCR Kit to support safe fluoropyrimidine-based chemotherapy — aims to reduce severe toxicity in patients with DPYD genetic variants.
• +4 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature10 records

Partnerships

13 partnerships are on record, tiered core and minor.

• PT Global Bioray TeknologicoreChannel Partner/ Reseller/ Distributor · 1 October 2024Collaboration signed October 2024 to commercialise the APIS ESR1 Mutations Kit and the Breast Cancer Subtyping Kit in Indonesia. PT Global Bioray Teknologi serves as the exclusive distributor for these products in Indonesia.
• Czech Genetics s.r.o.coreChannel Partner/ Reseller/ Distributor · 30 August 2024Collaboration signed August 2024 to commercialise the APIS ESR1 Mutations Kit in the Czech Republic. Czech Genetics serves as the distributor for the product in Czechia.
• Shiva ScientificcoreChannel Partner/ Reseller/ Distributor · 30 July 2024Collaboration signed July 2024 to commercialise the APIS ESR1 Mutations Kit in India. Shiva Scientific is the exclusive distributor for India.
• PharmaKureminorStrategic or Co-development Partner · 3 July 2023Collaboration signed July 2023 for the development of Clickmers related to neurodegenerative diseases. APIS contributes its Clickmer aptamer development expertise to PharmaKure's neurodegenerative disease research programmes.
• Biocartis NVcoreChannel Partner/ Reseller/ Distributor · 4 April 2023Collaboration to develop and commercialise a Breast Cancer Subtyping Test on the Biocartis Idylla™ platform, signed April 2023. Expanded in October 2023 to commercialise the APIS ESR1 Mutations Kit. Biocartis distributes ESR1 dPCR Kit, PIK3CA qPCR Kit, and other products across Europe, USA, and via local distributors globally.
• Moffitt Cancer CentercoreStrategic or Co-development Partner · 11 December 2020Master Collaboration Agreement on TROLL Biomarker Assessment, signed December 2020. Collaboration for the development and validation of TROLL biomarker assessment technology for cancer diagnostics.
• BeogenomicscoreTechnology or Integration · 4 September 2020Acquisition of Beogenomics, a specialised software developer with major expertise in Bioinformatics and Artificial Intelligence (BIOX). Beogenomics developed on-prem and secure cloud-based data analysis solutions and has been integrated to support APIS' new BIOX Service Line.
• ValiRx PLCcoreStrategic or Co-development PartnerAgreement to evaluate HER2 Clickmer® for characterising the expression of HER2 on Inaphaea's Patient-Derived Cells (PDCs) and application to CytoLytix's oncolytic peptide platform to selectively target HER2 positive cancer cells including breast and ovarian cancer.
• Clickmer® Systems GmbHminorStrategic or Co-development PartnerAffiliated entity developing Clickmer technology. Received BSFZ Seal of Innovation Competence from the Federal Ministry of Education and Research for 2024 and 2025. Awarded €1.1m grant for pandemic responsiveness diagnostic platform.
• SensID GmbHminorGTM or Marketing PartnerCollaborative webinar partner for ESR1 mutations educational content. SensID provides ESR1 reference set for accurate detection of mutations in cell-free DNA (cfDNA).
• BioSkrybminorGTM or Marketing PartnerCollaborative webinar partner for cloud computing in bioinformatics content. Joint webinar on 'Decoding the Future: How Cloud Computing is Reshaping Bioinformatics' with BioSkryb.
• InaphaeaminorStrategic or Co-development PartnerHER2 Clickmer® used for characterising the expression of HER2 on Inaphaea's Patient-Derived Cells (PDCs) as part of the ValiRx collaboration.
• CytoLytixminorStrategic or Co-development PartnerHER2 Clickmer® to be applied to CytoLytix's oncolytic peptide platform to selectively target HER2 positive cancer cells including breast and ovarian cancer.

Scale indicators6 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• Biocartis: Biocartis operates the Idylla™ molecular diagnostics platform and is both a distribution partner and a platform-adjacent competitor to APIS. The two companies co-developed a Breast Cancer Subtyping Test on Idylla™, making Biocartis the closest direct commercial peer in rapid molecular diagnostics.
• Qiagen: Qiagen is a global leader in molecular diagnostics with broad qPCR-based oncology and pharmacogenomics assay portfolios (e.g., therascreen, QIAstat-Dx). It is directly comparable to APIS as a developer of PCR-based IVD/RUO kits serving pharma, biotech, and clinical labs.
• Sysmex Inostics: Sysmex Inostics specialises in highly sensitive molecular diagnostics for oncology liquid biopsy, including digital PCR-based mutation detection (e.g., ESR1, PIK3CA). It is a direct peer to APIS's plasma-based cfDNA oncology kits in liquid biopsy mutation detection.
• Bio-Rad Laboratories: Bio-Rad's QX200 Droplet Digital PCR system and ddPCR reagent kits compete head-on with APIS's ESR1 dPCR Kit and other digital PCR assays. Both companies serve oncology and translational research customers with high-sensitivity mutation detection products.

Broad incumbents

• Cepheid (Danaher): Cepheid's GeneXpert system is a leading automated molecular diagnostics platform with broad oncology, infectious disease, and PGx test menus. It represents a broad incumbent benchmark for decentralised, sample-to-answer molecular testing that APIS's workflow claims to compete with.
• Roche Diagnostics: Roche Diagnostics offers the cobas® molecular diagnostics platform with extensive oncology, infectious disease, and PGx menus. It is a broad incumbent whose installed base and assay breadth shape the competitive landscape APIS competes within for hospital and reference-lab accounts.
• Abbott Molecular: Abbott Molecular provides the m2000 system and a broad menu of FDA-cleared molecular diagnostic assays in infectious disease, oncology, and PGx. It is a broad incumbent whose scale, regulatory depth, and global reach define the bar for new molecular Dx entrants.

Emerging players

• Exact Sciences: Exact Sciences focuses on molecular diagnostics for early cancer detection and treatment guidance (e.g., Oncotype DX, Cologuard). It is an emerging peer in oncology molecular diagnostics with overlapping themes in biomarker-driven clinical decision support.
• Guardant Health: Guardant Health is a leader in liquid biopsy and comprehensive genomic profiling for oncology (Guardant360, Guardant Reveal). It is an emerging peer whose liquid biopsy mutation-detection focus overlaps with APIS's ESR1, PIK3CA, and MET cfDNA/cfRNA assays.
• NeoGenomics: NeoGenomics provides oncology-focused molecular and pathology testing services to clinicians and biopharma. It is an emerging peer serving the same oncology diagnostic market as APIS, particularly where pharma-sponsored companion diagnostic work is involved.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Apis Assay Technologies