Biofidelity

Biofidelity is a genomic technology company developing simplified molecular diagnostic solutions for precision medicine. Founded in 2019 by CEO Dr. Barnaby Balmforth and Cameron Frayling, the company is headquartered in Cambridge, UK, with a U.S. base and clinical diagnostic laboratory in Research Triangle Park, North Carolina. Dr. Balmforth holds a PhD from Cambridge and has over a decade of experience in genomic technology development.

The company's mission is to make precision medicine more accessible to patients globally. It aims to provide fast, reliable, and cost-effective genomic biomarker detection to guide cancer treatment decisions. Biofidelity has raised a total of $60 million in funding over four rounds, with its latest Series B in April 2024 securing $24 million. Investors include Agilent Technologies, Octopus Ventures, BlueYard Capital, and Longwall Ventures.

Biofidelity’s core technology platform, ASPYRE (an acronym for Assay for Single-molecule PYrosequencing), is designed to simplify and accelerate the detection of a wide panel of genomic biomarkers from a single tissue or blood sample. This technology provides an alternative to more complex and time-consuming methods like next-generation sequencing (NGS), delivering actionable results in hours instead of weeks. The ASPYRE platform is designed to run on existing qPCR instruments, which are widely available in laboratories, facilitating decentralized testing. The process involves hybridizing probes to DNA, digesting perfectly matched probes on mutated DNA, circularizing the digested probes, and then amplifying only the circularized probes for detection.

The company’s first commercial products are focused on non-small cell lung cancer (NSCLC). ASPYRE-Lung is offered as both a Laboratory Developed Test (LDT) performed in Biofidelity's lab and as reagents for research use (RUO). These products simultaneously analyze multiple DNA and RNA biomarkers recommended in clinical guidelines, such as mutations and fusions, helping oncologists make rapid treatment decisions. The business model targets oncologists, pathologists, clinical laboratories, and biopharmaceutical companies for clinical trial enrollment. Additionally, Biofidelity is developing another technology, Enspyre®, a target enrichment platform designed to enhance NGS efficiency by removing unwanted DNA, thereby improving sensitivity and reducing costs for applications like minimal residual disease (MRD) testing.

Keywords: precision oncology, genomic diagnostics, biomarker detection, ASPYRE technology, non-small cell lung cancer, liquid biopsy, molecular diagnostics, qPCR, cancer diagnostics, target enrichment, genomic testing, Barnaby Balmforth, clinical trials, NSCLC, DNA analysis, RNA analysis, laboratory developed test, research use only, Enspyre, precision medicine