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21 August, 2020 - 10:12 By Tony Quested

Biofidelity raises $12m to accelerate disruptive cancer diagnostics

Cambridge UK startup Biofidelity Ltd, a cancer diagnostics company, has completed a $12 million Series A financing to fast-track its technology to a $15 billion global market. 

The company says its technology will enable a dramatic simplification of precision genetic testing to ensure many more cancer patients receive optimal diagnosis and therapy.

While the initial focus is on lung cancer there is potential for broad application across the cancer market.

The round was led by BlueYard Capital and backed by experienced investors including Longwall Ventures and Agilent Technologies, a global leader in life sciences and diagnostics.

Biofidelity says its disruptive technology combines fast, affordable, easy to interpret results, to dramatically simplify genetic testing while providing all the key benefits of next generation sequencing. 

The company estimates that 95 per cent of cancer patients are currently excluded from NGS due to high cost, complexity and slow turnaround times.

Biofidelity provides clinically actionable data based on ultra-sensitive detection of the markers recommended in cancer treatment guidelines, enabling oncologists to prescribe the right cancer drug at the right time to many more patients. 

Straightforward adoption on existing infrastructure is expected to greatly increase the number of laboratories able to offer superior cancer diagnostics.

Biofidelity is initially focusing on diagnosis of non-small cell lung cancer, with potential across a broad range of cancers as well as applications in the detection of resistance to therapy and disease recurrence.

In January, Biofidelity – founded only last year – announced the successful completion of a study to detect key lung cancer mutations in collaboration with Agilent Technologies. 

The collaboration, using an assay developed by Biofidelity, demonstrated an improvement in sensitivity of 50 times that achieved with current FDA-approved PCR-based diagnostics. 

This matched the sensitivity of specialised NGS assays, which require error-correction technology, while providing a dramatic simplification of workflows from more than 100 steps to just four. 

Assays were performed using standard laboratory instrumentation, demonstrating the potential for straightforward adoption of Biofidelity’s panels in decentralised testing laboratories around the world.

The Series A funds will be used to accelerate the development and clinical validation of oncology panels for treatment selection and patient monitoring in oncology, and to bring these assays rapidly to market through direct sale, partnering and collaboration.

Dr Barnaby Balmforth, chief executive officer and co-founder of Biofidelity, said: “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. 

“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.”

Cameron Frayling, co-founder, added: “With an initial focus on well-established, widely reimbursed markers used in targeted treatment of non-small cell lung cancer, Biofidelity has potential in a broad range of cancers and future applications in routine monitoring of patients for detection of resistance to therapy and disease recurrence.”

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