Newsroom

APIS receives FDA Breakthrough Device Designation for DPYD HT qPCR Kit

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the APIS DPYD HT qPCR Kit (IVD), an advanced molecular DPYD genotyping test to support safe and effective therapy with fluoropyrimidine-based chemotherapeutics.

October - 2025

Read the full press release by clicking the image below

ValiRx PLC and APIS signed an agreement to evaluate HER2 Clickmer®

HER2 Clickmer will be initially used for characterising the
expression of HER2 on Inaphaea's PDCs, the technology will also be applied to CytoLytix's oncolytic peptide platform in order to selectively target HER2 positive cancer cells, including breast and ovarian cancer.

October - 2025

Clickmer® Systems GmbH receive the BSFZ Seal of Innovation Competence from the Federal Ministry of Education and Research for 2025.

We are honoured to receive the BSFZ Seal of Innovation Competence from the Federal Ministry of Education and Research for 2025. This recognition underscores our unwavering dedication to advancing innovation in the field of aptamers.

June - 2025

Our Head of QA and RA Colette Walker has been featured in RQA’s Quasar Magazine

Her article titled ‘Mastering the Maze: Crafting a QMS for IVD Compliance’ offers valuable insights on:

· The strategic value of early QMS adoption

· Designing your QMS, aligned with your business needs

· Steps for a successful QMS implementation

· Competitive advantage for a quality-driven approach

February-2025

APIS awarded additional grant funding under the DEVOTE programme

We are pleased to announce the extension of the highly successful DEVOTE grant award from the UK Government’s Innovation Accelerator programme led by Innovate UK.

22-April-2025

APIS Announces New Collaboration

PT Global Bioray Teknologi and APIS Assay Technologies Sign Collaboration to Commercialise the ESR1 Mutations Kit & the Breast Cancer Subtyping Kit

01-Oct-2024

Clickmer® Systems GmbH receive the BSFZ Seal of Innovation Competence from the Federal Ministry of Education and Research for 2024.

We are honoured to receive the BSFZ Seal of Innovation Competence from the Federal Ministry of Education and Research for 2024. This recognition underscores our unwavering dedication to advancing innovation in the field of aptamers.

17-Sep-2024

APIS Announces New Collaboration

Czech Genetics and APIS Assay Technologies Sign Collaboration to Commercialise the APIS ESR1 Mutations Kit

30-Aug-2024

APIS Announces New Collaboration

Shiva Scientific and APIS Assay Technologies Sign Collaboration to Commercialise the APIS ESR1 Mutations Kit

30-Jul-2024

APIS Assay Technologies Achieve ISO 13485:2016 Certification 2024

The design, development, manufacture and distribution of in vitro molecular diagnostics assays and associated software for detection of biomarkers linked to human diseases including cancer and infectious diseases.

01-Jul-2024

APIS Statement to Net Zero

APIS is committed to achieving Net Zero emissions by 2045 for emissions scopes 1, 2 and 3. The commitment was made on 25MAR24 by Ian Kavanagh, Chief Executive Officer.

25-March-2024

APIS Announces Publication on Breast Cancer Subtyping Kit by The Royal Surrey Hospital NHS Foundation Trust

The article is titled ‘Breast Cancer Molecular Subtyping in Practice: A Real-World Study of the APIS Breast Cancer Subtyping Assay in a Consecutive Series of Breast Core Biopsies‘ published in MDPI.

23-Feb-2024

APIS Releases First Publication on Breast Cancer Subtyping Kit

The article is titled ‘Comprehensive and Accurate Molecular Profiling of Breast Cancer through mRNA Expression of ESR1, PGR, ERBB2, MKI67, and a Novel Proliferation Signature‘ published in MDPI.

23-Jan-2024

APIS Announces New Collaboration

Biocartis Announces Expansion of its Collaboration with APIS Assay Technologies to Commercialise the APIS ESR1 Mutations Kit

12-Oct-2023

APIS Announces Changes to the Executive Management Team

APIS Assay Technologies Ltd. Announces Appointment of New CEO and Executive Chairman of the Board

20-Jul-2023

APIS Announces New Collaboration

PharmaKure and APIS Assay Technologies sign a collaboration for the development of Clickmers related to neurodegenerative diseases.

03-Jul-2023

APIS Announces New Partnership

Biocartis and APIS Assay Technologies Sign Collaboration to Develop and Commercialise a Breast Cancer Subtyping Test on the Idylla™

04-Apr-2023

APIS Assay Technologies Achieve ISO 13485:2016 Certification 2023

The design, development, manufacture and distribution of in vitro molecular diagnostics assays for detection of biomarkers linked to human diseases including cancer and infectious diseases.

02-Apr-2023