UK Startup Biofidelity Ltd. Acquires $12 Million in Series A Financing

The Cambridge, UK-based cancer diagnostics company which was founded in early 2019, plans to use the funds to advance the development, clinical validation, and commercialization of oncology panels to enable precision genetic testing for cancer patients.

By Rajaneesh K. Gopinath, Ph.D.

On August 20th, Biofidelity Ltd., a British startup company “providing high performing novel molecular assays for the sensitive detection of low-frequency genetic mutations,” announced the successful completion of a $12 million Series A financing. The financing round was led by BlueYard Capital and supported by Biofidelity’s reliable collaborators, Longwall Ventures and Agilent Technologies. Notably, Longwall Ventures had earlier led the £0.75 million seed financing round for the company in 2019.

“Biofidelity has the true potential to democratize highly accurate cancer diagnostics by empowering clinicians everywhere to positively change patient lives’ by providing access to the highest standard of care to every patient, everywhere”, said Ciarán O’Leary, General Partner, BlueYard Capital. “Biofidelity’s unique combination of extremely high sensitivity, fast turn-around times, simplicity, and affordability means they can expand the market significantly and reduce reliance on centralized diagnostics that are currently only available to a small fraction of patients.”

Simple Workflow, Superior Sensitivity

Biofidelity aims to simplify genetic testing and make it accessible to patients who cannot afford next-generation sequencing (NGS). The company claims that it’s genetic tests “can detect as little as a single molecule of mutated DNA against the background of billions of healthy molecules”. As opposed to currently available sequencing assays, Biofidelity’s technology can detect large panels of mutations at a sensitivity of <0.1% variant allele fraction (VAF), without the need for complex workflows or bioinformatics.

At present, the company is focusing on the diagnosis of non-small cell lung cancer (NSCLC), with the potential to expand to a broad range of cancers. Back in January, Biofidelity and Agilent Technologies announced the successful completion of a study to detect key lung cancer mutations. The collaboration saw the former’s molecular assays demonstrating a 50 fold improvement in sensitivity versus current FDA-approved PCR-based diagnostics. Its performance was on par with some specialized NGS assays, and its workflow was dramatically simplified to just four steps as compared to over 100 steps in NGS. These tests were performed using standard laboratory instruments supporting the adoption of Biofidelity’s panels globally.

“Delivering on the promise of precision medicine to improve outcomes for cancer patients relies on clinicians being able to precisely identify actionable genetic markers. Our assays will enable them to make the right decisions regarding treatment and to detect when a cancer has recurred or become resistant to therapy”, said Dr. Barnaby Balmforth, Chief Executive Officer and co-founder of Biofidelity.

“We are removing the barriers that prevent the vast majority of patients from having access to the high-quality information associated with existing DNA sequencing approaches. Biofidelity’s assay is specifically designed to allow easy adoption by laboratories around the world and to enable all cancer patients to receive optimal treatment based on best-in-class information,” he added.

Related Article: OneOncology Enters First-of-its-Kind Partnership with FMI to Advance Personalized Medicine at Community Oncology Practices

References

1. https://biofidelity.com/2020/08/20/biofidelity-raises-12m-in-series-a-financing-to-accelerate-launch-of-disruptive-cancer-diagnostic-technology/
2. https://biofidelity.com/2019/09/03/next-gen-molecular-assay-play-biofidelity-secures-seed-financing-and-appoints-dr-heiner-dreismann-as-senior-advisor/
3. https://biofidelity.com/2020/01/09/biofidelity-and-agilent-complete-successful-molecular-assay-study/

Author

Rajaneesh K. Gopinath