Successful alpha testing of Biofidelity’s ASPYRE-Lung reagents demonstrates breakthrough capabilities and ease of use

ASPYRE-Lung panel set up and multiple samples analyzed in US & UK test labs in as little as one day

Consistent performance demonstrated across test sites and genetic variants

Cambridge, UK, 14 September 2021 – Biofidelity Ltd, the cancer diagnostics company, today announced the successful completion of alpha testing of its new ASPYRE-Lung reagents at multiple laboratory locations in the US and UK.  

Biofidelity’s ASPYRE-Lung reagents utilize the breakthrough ASPYRE technology to enable ultra-sensitive detection of genetic markers across 11 key lung cancer genes. Through a dramatic simplification of workflows and the use of existing PCR instrumentation, the technology has been developed to remove the barriers to access to genetic information, and to significantly reduce turnaround times.

The laboratories participating in the initial alpha testing included:

  • Cancer Research UK

  • ATDBio Ltd

  • Fred Hutchinson Cancer Research Center

  • Medical College of Wisconsin

Each of the participating laboratories was able to set up and perform ASPYRE-Lung testing on their existing real-time PCR equipment in as little as one day. Operators from a range of educational backgrounds were provided with Instructions for Use with no or minimal additional training required.   

Results from the alpha study were consistent across the test sites and with the results obtained from the assay at Biofidelity’s laboratory in Cambridge, UK, providing a powerful demonstration of the simplicity and speed with which high-sensitivity multi-gene testing can be performed using ASPYRE.

The ease of adoption of the ASPYRE-Lung reagents on our existing real-time PCR equipment was remarkable. Our laboratory was able to set up the ASPYRE-Lung panel and analyse multiple samples in less than one day. This is truly transformational and has the potential to make ultra-sensitive detection of genetic markers accessible to many more laboratories.
Dr. Honey Reddi
Clinical Laboratory Director and Chief Medical Director, at the Genomic Sciences and Precision Medicine Center, Medical College of Wisconsin

We are extremely pleased with the results generated by our partner laboratories, and by the ease with which the ASPYRE-Lung panel can be set up in independent sites. We believe that decentralization is key to ensuring every patient has access to precision cancer diagnostics. Our ASPYRE reagents are the first step towards this, and the alpha testing results have proven that labs outside Biofidelity can achieve the same standard of results quickly and efficiently. This is a very important step in our goal of commercializing the ASPYRE technology and making it available to laboratories all over the world.
Dr. Barnaby Balmforth
Chief Executive Officer of Biofidelity

ASPYRE enables ultra-sensitive detection of panels of DNA and RNA markers on real-time PCR platforms, with results available in a matter of hours. By providing comprehensive actionable information in a dramatically reduced turnaround time, ASPYRE will provide oncologists and pathologists with the information needed to make rapid, precise treatment decisions, extending and improving lives by enabling all patients to receive the right treatment at the right time. 

ASPYRE-Lung is the first in a pipeline of precision oncology diagnostics that will be launched through Biofidelity’s US site as clinical assays. Global launch of reagents for research use is scheduled to begin in early 2022, enabling laboratories to perform high precision multi-gene analysis from tissue or blood on existing real-time PCR platforms.