Biofidelity Awarded Innovate UK Grant to Develop Non-Invasive Tests to Enable Precision Medicine

Biofidelity Ltd, a company providing advanced molecular assays for the sensitive detection of low-frequency genetic mutations, today announces it has received £500,000 in grant funding from Innovate UK, the UK’s Innovation Agency. The grant will enable Biofidelity to explore applications of its novel chemistry platform for oncology patient monitoring, with samples taken directly from patient blood.

The grant to Biofidelity is through Innovate UK’s ‘Innovation in Precision Medicine Investment Accelerator’ and will support the development of Biofidelity’s novel chemistry platform for ultra-sensitive, affordable detection of gene targets, enabling better targeting of therapies and monitoring of their effectiveness.

The grant will co-fund a 12-month project to validate the chemistry for sensitive detection of mutations used to guide treatment of non-small-cell lung cancer, including acquired mutations which confer resistance to common therapies.

Biofidelity will develop its platform chemistry for use in companion diagnostic tests. Such tests help guide therapy, providing vital information on potential efficacy while enabling monitoring of the acquisition of resistance. Resistance monitoring is critical and indicates when a patient should be switched to an alternative therapy. This can be useful during treatment with cancer drugs, as tumours will often develop mutations which confer resistance to the therapy.

Genomics-based diagnostic tests are generally tissue-based, requiring an invasive, costly and potentially high-risk procedure to obtain a sample from the patient. Non-invasive testing (or ‘liquid biopsy’), which uses analysis of circulating cell-free DNA in the blood, is an alternative which holds great promise as a method of routine screening, however, a typical liquid biopsy sample may contain as little as a single target DNA molecule, often differing from healthy DNA by only a single point mutation. As a result, a very high level of specificity is required to avoid false positives.

Biofidelity’s proprietary platform uses a novel set of biochemical reactions and an easily adopted workflow to enable target DNA sequences to be detected and protected while irrelevant DNA is removed.

The extreme sensitivity and specificity of Biofidelity’s assays also enables the detection of genetic mutations or target genes at a much earlier stage, allowing earlier intervention with targeted treatment.

The chemistry can also be multiplexed to enable simultaneous detection of large panels of DNA mutations at extremely low frequencies, making it suitable for use for a broad range of cancers. Recognised as highly beneficial to patients by both NICE and the FDA, the companion diagnostic market is currently estimated at US$6 billion and predicted to grow at a compound annual growth rate (CAGR) of as much as 22% over the next 5 years.

Our aim is to improve patient outcomes by providing easily adopted advanced molecular assays that dramatically increase the speed and effectiveness of diagnosis. Our platform chemistry could enable precision medicine across a broad range of therapies, with samples taken from either blood or tissue, meaning both routine screening and patient monitoring become far more cost effective and less intrusive. The funding from Innovate UK will accelerate the rate at which we can successfully implement the technology for effective targeting of therapies.
Dr Barnaby Balmforth
Chief Executive Officer, Biofidelity

Together with its £750,000 seed financing, announced earlier this month, the Innovate UK grant brings the total amount to date raised by Biofidelity to £1.25 million.