Biofidelity granted key patents in US, Europe, and China

New patents in global markets strengthen and secure intellectual property for innovative platform technology designed to remove the noise from genomic data, making genomics more widely accessible.

CAMBRIDGE, UK and RESEARCH TRIANGLE PARK, NORTH CAROLINA, USA, September 8, 2022 – Biofidelity, a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in, announced today the issuance of several new patents in the US, Europe, and China. The patents further strengthen the Company’s intellectual property position and the protection of the technology underpinning its first commercial product, ASPYRE-Lung®.

ASPYRE® is a completely new technology that simplifies and accelerates the detection of actionable biomarkers. When utilized as a molecular diagnostic it applies a unique enzymatic reaction to perform Simplified Molecular Profiling (SMP). SMP is a novel approach to molecular testing that enables simple, precise, and targeted identification of panels of genomic biomarkers to facilitate fast clinical decision-making – in essence, removing the haystack to reveal the needle. The unique technology is used to create targeted, multigene biomarker panels that are ultrasensitive, highly specific, and capable of returning results in a single day.

The newly issued patents protect both the enzymatic processes that underpin the ASPYRE technology and the simple four-step methodology through which the technology is employed. Together these enable the testing for the presence of a large number of genomic markers, including those used in the identification of cancer, infectious disease, and transplant organ rejection.

Newly issued European patent EP3842549 will provide protection for ASPYRE until 2040 in key European countries. The ASPYRE technology is protected by 22 granted patents, including two US patents, US10,961,569 and US11,332,780, Chinese patent CN112424379, and patents in key European countries, including the UK, France and Germany. Four more patents will come into force in the coming months, providing additional protection.

The Biofidelity intellectual property (IP) portfolio further comprises 29 pending patent applications, including five Patent Cooperation Treaty (PCT) applications providing the potential to obtain patent coverage in more than 150 countries. “These newly issued patents provide broad and strong protection of our ASPYRE technology and highlight the novelty of our unique approach to genomic analysis. By removing the noise from genomic data, our mission is to unlock the true potential of genomics, providing only the information needed and making genomic analysis simpler, faster, and more accurate,” said Biofidelity CEO Dr. Barnaby Balmforth. “With ASPYRE, precision genomic testing can be carried out using existing PCR instruments, of which there are more than 100,000 globally, significantly expanding access to the benefits of precision medicine,” Balmforth adds. “The technology is designed to overcome the complexity, slow-turnaround, and cost barriers that have prevented the promise of genomics from transforming human health and have, for too long, limited access to targeted therapies for cancer patients.”

“These key patents represent the depth of knowledge and expertise underpinning the core technology upon which Biofidelity is built”, said Biofidelity Director of Technology Development Dr. Magdalena Stolarek-Januszkiewicz. “The opportunity to apply the technology to transform human health beginning with lung cancer, the leading cause of cancer deaths globally, is incredibly rewarding.”

About Biofidelity
Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, more accurate, and with increased confidence.

Founded in 2019, we are a rapidly growing private company of scientists, engineers, physicians and commercial experts dedicated to making genomics more widely accessible.

For more information, please visit biofidelity.com and connect with us on LinkedIn and Twitter

About ASPYRE
Biofidelity’s unique ‘Allele-Specific PYrophosphorolysis REaction’ (ASPYRE) is the enabling technology behind Simplified Molecular Profiling, making it possible to generate assays that accelerate the detection of actionable biomarkers. The ASPYRE technology is used to create targeted, multigene biomarker panels that are ultrasensitive, highly specific, and capable of returning results in a single day. ASPYRE-Lung, the first clinically focused ASPYRE product, is a fast, highly sensitive, lung cancer panel that tests for all clinically actionable genomic biomarkers in a single assay. Using either tissue or blood, ASPYRE-Lung helps identify patients who will benefit from targeted therapies at a fraction of the time and cost of other biomarker testing methods, like next generation sequencing (NGS).

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