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13 January, 2022 - 12:32 By Tony Quested

Biofidelity set to trigger diagnostics revolution in US

Cambridge Science Park company Biofidelity expects to launch ASPYRE-Lung, its first commercial diagnostic assay in the US in early 2022.

Biofidelity is a pioneer in molecular diagnostics whose mission is to unlock the benefits of precision medicine for all patients by increasing access to early detection, precision diagnosis and routine monitoring with its revolutionary technologies. 

Its breakthrough ASPYRE technology delivers ultra-sensitive, comprehensive biomarker results quickly and affordably, enabling patients and clinicians to make fast, well-informed treatment decisions.

Founded in 2019 in Cambridge, Biofidelity is a rapidly growing private company that recently expanded to include both a US headquarters and state-of-the-art clinical cancer diagnostic laboratory located in Research Triangle Park, North Carolina. 

In the past 20 years, DNA sequencing has transformed clinicians’ understanding of cancer. Knowledge of the genomic alterations (mutations in DNA or RNA) that drive cancer enabled the development of new therapies that directly target these specific mutations. The result is individualised cancer treatments that offer better outcomes for patients, with fewer side effects and an improved quality of life. 

But in order to select the right targeted therapy, doctors must first test for these actionable mutations, or biomarkers, in the patient’s cancer cells. Unfortunately, there are several barriers that prevent a majority of patients from accessing comprehensive biomarker testing. 

As a result, fewer than half of metastatic cancer patients in the United States who could benefit from targeted therapy actually undergo biomarker testing to guide their treatment.

Biofidelity’s mission is to break down these barriers and make highly targeted precision cancer treatments available to more patients by simplifying the detection of actionable biomarkers. 

With the ability to perform ultra-sensitive detection of panels of DNA and RNA mutations from tissue or blood using existing laboratory equipment, ASPYRE provides comprehensive actionable results in a matter of hours instead of weeks, at a fraction of the cost of sequencing methods. 

This quickly and easily provides the information needed to get patients started on the treatment that’s right for them, helping to improve their quality of life and increase their chances for long-term survival.

The company has just expanded its Scientific Advisory Board to include the aptly named Lee N. Newcomer – an oncologist and seasoned healthcare executive who says the company’s breakthrough technology is a “game-changer that will increase access to biomarker testing for cancer patients making treatment decisions.”

Dr Newcomer joins several other leaders from the clinical, pharmaceutical and patient advocacy fields as they help guide the development and launch of Biofidelity’s ASPYRE.

Dr Newcomer has held multiple senior executive roles at one of the largest health insurers in the US. Most recently, he spent 15 years as senior VP for oncology and genetics at United Healthcare.

Barnaby Balmforth, CEO at Biofidelity, said: “Dr Newcomer is a distinguished healthcare leader with a unique combination of expertise in the field of precision oncology and a passion for fostering disruptive innovations that improve the quality of cancer care.

“We are thrilled to welcome him to the Scientific Advisory Board and know that his contributions will be invaluable in helping to bring this revolutionary technology to market and enable more patients to access the lifesaving benefits of precision medicine.”

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