APIS Assay Technologies, a UK-based company specialising in molecular diagnostics, has announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s APIS DPYD HT qPCR Kit (IVD), an advanced molecular DPYD genotyping to support safe and effective therapy with fluoropyrimidine-based chemotherapeutics.
Fluoropyrimidines, such as 5-fluorouracil (5-FU) and capecitabine, are widely used in the treatment of various solid tumours. However, patients carrying certain DPYD variants are at increased risk of severe or even life-threatening toxicity from these chemotherapeutic agents. Early and accurate identification of DPYD variants enables clinicians to personalise treatment regimens and significantly improve patient safety.
The FDA Breakthrough Device Designation is reserved for medical devices that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions.
The designation was granted based on the APIS DPYD HT qPCR Kit’s potential to address a critical unmet medical need by enabling the pre-treatment identification of patients at risk of severe fluoropyrimidine-related toxicity.
The APIS DPYD HT qPCR Kit (IVD) detects all seven Tier 1 DPYD variants recommended for testing by Association of Molecular Pathology (AMP) using a quantitative PCR (qPCR)-based approach. The assay will generate rapid, accurate, and cost-effective results directly from whole blood, minimising sample preparation. It has been designed for broad population coverage, ensuring accurate genotyping across diverse ancestries.
An abstract outlining the assay development will be presented at AMP 2025 Annual Meeting in Boston, MA in November 2025.
By enabling timely and targeted dosing decisions, once approved, the test is expected to reduce the incidence of severe fluoropyrimidine-related adverse events, improve patient outcomes, and lower healthcare costs associated with toxicity management.
“Receiving the FDA Breakthrough Device Designation is a major milestone for APIS and for patients receiving fluoropyrimidine-based chemotherapy,” said Dr. Ian Kavanagh, Chief Executive Officer of APIS Assay Technologies. “Our mission is to make precision oncology accessible and actionable. This designation recognises the potential of our DPYD test to empower clinicians with the information they need, quickly and accurately, to prevent avoidable toxicity and improve cancer care globally.”
In addition to the FDA designation, part of the development of this test was supported by Innovate UK under the DEVOTE programme to further advance APIS’ pharmacogenetic assay portfolio and support ongoing clinical validation studies.
