Amoy Diagnostics (AmoyDx) and Almac Diagnostic Services have developed a partnership over the past five years, significantly advancing the field of precision oncology. This collaboration has led to the development and implementation of various Amoy assays as companion diagnostics within the European Union, including the AmoyDx® HRD Complete Assay and the AmoyDx® BRCA Plus Panel.
At the Festival of Genomics and Biodata 2025, Dr Jim Williams of Almac Diagnostics introduced the partnership in his talk “Advancing Precision Oncology: Technical Insights into the AmoyDx HRD Complete Panel in a Leading UK & EU Lab.”
AmoyDx: leading innovation in precision oncology
AmoyDx is a diagnostic company dedicated to transforming cancer care and offers a range of innovative products. They are a leader in precision oncology in China, with their PCR-based diagnostic panels being used in all of the top 500 hospitals within the country, and their NGS-based panels used in 80.5% of all NGS-equipped hospitals.
Almac Diagnostics: expertise in custom assay development
The Almac Group is an established contract development and manufacturing organisation (CDMO) that offers a range of services for the drug development, pharmaceutical and biotech sectors. Their diagnostic services provide custom assay development and support for third-party assay development. These expertise, along with their accredited laboratories in the UK, complement the validation of Amoy’s products for the UK and European market. Being platform and chemistry agnostic, Almac selects the most appropriate technology for each case, ensuring optimal outcomes.
Breakthrough in prostate cancer: HRD complete assay as a companion diagnostic
A notable achievement of this partnership was the AmoyDx® HRD Complete Assay clinical bridging study. This assay was selected to be the companion diagnostic (CDx) for a drug in Europe for patients with prostate cancer and BRCA1/2 mutations. Almac was selected to perform the clinical bridging study between the AmoyDx panel and the clinical trial assay (CTA), and the CDx that had already been validated for use in the US.
Rigorous laboratory qualification and reanalysis of clinical trial samples
AmoyDx qualified Almac as a laboratory for the study, with Almac assigning a Principal Investigator and providing regulatory support. Samples from the clinical trial which had already been analysed with concurrent results between the CTA and the US CDx were reanalysed with the Amoy CDx panel at Almac’s laboratory to confirm the status of BRCA1 and BRCA2 SNVs, indels and homozygous deletions.
Overcoming sample quality challenges in clinical bridging studies
The study faced challenges due to requirements for sufficient formalin-fixed, paraffin-embedded (FFPE) DNA from tumour biopsies, often dealing with highly degraded samples with limited material remaining after the previous clinical trial. Of the 439 samples shipped to Almac, 200 gave valid HRD results. The study achieved good concordance of the AmoyDx HRD assay with both the CTA and the US CDx and met acceptance criteria despite the challenging nature of the samples.
Ensuring extraction method compatibility and assay robustness
The partnership also aimed to qualify multiple extraction kits for use with the AmoyDx panel to facilitate FFPE extraction. In testing 24 leftover samples for extraction methods, 23 demonstrated concordant results between extraction methods used for the clinical trial and alongside the US CDx, underscoring the robustness of Amoy’s assay.
Expanding to breast cancer: the BRCA Plus panel validation study
In a second clinical bridging study, the AmoyDx BRCA Plus Panel was selected as the European companion diagnostic panel for a drug in the treatment of patients with breast cancer and BRCA mutations. In this instance, the samples were less challenging, with 1,509 samples of the 1521 provided qualifying for inclusion in assay validation. The results of this study are currently pending.
Driving global access to precision diagnostics
This collaboration leverages Almac's proficiency in European and UK regulations to facilitate the introduction of AmoyDx’s panels into these markets. By utilising a range of platforms compatible with AmoyDx tests, the partnership continues to support significant developments in precision oncology, ultimately aiming to improve patient outcomes worldwide.
Learn more about Amoy's range of precision oncology panels or contact our Amoy Diagnostics specialists for further information.