Biofidelity opens US headquarters and new cancer diagnostic laboratory

Facility in RTP North Carolina will enable US launch of precision diagnostics using breakthrough ASPYRE technology

Cambridge, UK, 28 July 2021 – Biofidelity Ltd, the cancer diagnostics company, today announces the opening of its US headquarters in Research Triangle Park, North Carolina, expanding its presence in the key US market ahead of its first product launch later this year. The location will house a state-of-the-art clinical cancer diagnostic laboratory that will perform the new ASPYRE-Lung assay for oncologists, pathologists, laboratories and pharmaceutical companies using Biofidelity’s break-through ASPYRE technology.

Biofidelity expects to launch ASPYRE-Lung, its first commercial diagnostic assay, later this year, enabling ultra-sensitive multi-gene characterisation of lung cancer mutations from tissue or blood samples in a fraction of the time and at a fraction of the cost of current techniques.

ASPYRE enables affordable, 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 provides 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 the US site as clinical assays, with global launch of reagents for research use scheduled for early 2022, enabling laboratories to perform high precision multi-gene analysis from tissue or blood on existing real-time PCR platforms.

The opening of our US headquarters and laboratory is a major step forward in Biofidelity’s mission to realize the potential of precision cancer diagnostics for patients around the world. With the launch of our first product anticipated before the end of the year, our US laboratory is essential to enable us to service our key customer base. It will also allow us to work directly with pharmaceutical developers to reduce the time and cost of clinical studies, by accelerating patient enrolments and reducing drop-out rates.
Dr. Barnaby Balmforth
Chief Executive Officer

Establishing our own clinical laboratory in the US will enable us to provide fast, highly-sensitive analysis of actionable genetic markers, giving oncologists and patients what is needed for optimal treatment decisions. ASPYRE-Lung offers multi-gene analysis with higher precision than NGS, without the complexity and slow turnaround times that impact patient care.
Dr. Robert Osborne
Chief Operating Officer