Precision Cancer Genomics Company Adds $23M in Early Funds

(Gerd Altmann, Pixabay)

1 Feb. 2022. A developer of cancer diagnostics using genomics to detect precise biomarkers is raising $23 million in the second part of its first venture round. Biofidelity, a three year-old enterprise in Cambridge, U.K., says its process simplifies detection of genetic indicators in tumors enabling more precise therapies for cancer patients.

The Biofidelity technology, called Aspyre, is based on pyrophosphorolysis, a process that reverses conventional chemical synthesis of DNA isolated from samples, with enzymes to directly digest and analyze DNA. For pyrophosphorolysis to work, says Biofidelity, DNA samples must be perfectly matched, otherwise the process is blocked when mismatches occur. Aspyre first isolates and amplifies DNA in samples to enrich target genes for testing. The technology then adds probes with synthetic DNA identifiers representing actionable cancer-causing mutations associated with the target genes.

The probes combine with target regions in patients’ DNA samples indicating a match and the presence of cancerous mutations in the sample, but not mismatched healthy or irrelevant DNA. Matched DNA samples are completely digested, releasing the tail of the DNA probe strand, which forms into a circle. Aspyre seeks out full circular tail formations that indicate complete matches with cancerous biomarkers, while incomplete circles from mismatched DNA are bypassed.

Detect hundreds of biomarkers across multiple genes

Biofidelity says its process is highly sensitive, allowing for detection of single molecules even in small samples from both tissue and liquid biopsies. The process, says the company, can run on current polymerase chain reaction or PCR genomic analysis equipment and return results in under four hours. In addition, says Biofidelity, Aspyre can detect hundreds of biomarkers across multiple genes in a single test without compromising performance.

The company’s lead product is Aspyre-Lung that it says can detect 111 biomarkers — 77 DNA mutations and 34 RNA fusions — across 11 genes, as recommended by international cancer guidelines for non-small cell lung cancer. Biofidelity says the technology can be extended across a broader range of cancer types, extending precision cancer care to more patients.

Biofidelity is raising $23 million in the second part of its first venture round, led by technology investor Octopus Ventures in London, joined by SBI Investment Co. Ltd. and current investors. In Aug. 2020, Biofidelity raised $12 million in the first part of the round, with investments from BlueYard Capital, Longwall Ventures, and Agilent Technologies. At start-up, in Sept. 2019, the company raised $0.75 million in seed funds.

Biofidelity plans to use the proceeds from the round to launch its Aspyre-Lung product. “Our mission,” says Biofidelity CEO Barnaby Balmforth in a company statement, “is to ensure that all patients diagnosed with cancer have access to the genomic information they need to receive the best possible treatment.” Balmforth adds, “This financing is an important step towards making this vision a reality, enabling us to launch our revolutionary technology and to make comprehensive biomarker testing faster, more affordable, and more accessible than ever before.”

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