Biofidelity Introduces Novel Lung Cancer Assay for Precision Medicine

Biofidelity, a British genomic technology company with U.S. headquarters in Morrisville, has commercially launched a novel assay to guide the treatment of non-small cell lung cancer in U.S. patients.

The assay, called ASPYRE-Lung, simplifies and accelerates the detection of biomarkers for lung cancer, enabling clinicians to determine which treatment is best for each patient at a lower cost than current RNA and DNA sequencing tests, and in days instead of weeks, the company said in a news release.

"Despite incredible growth in the genomics market and the exciting range of targeted treatment options for lung cancer, clinicians need better tools to make faster, more informed decisions for their patients," said Barnaby Balmforth, Ph.D., co-founder and chief executive officer of Biofidelity. "Today's launch of ASPYRE-Lung reflects Biofidelity's mission to bring the benefits of precision medicine to millions of patients around the world."

Lung cancer is the leading cause of cancer deaths in the United States, with more than 200,000 cases diagnosed every year, according to the U.S. Centers for Disease Control and Prevention.

Targeted treatments offer enormous advantages for patients who are eligible to receive them, yet 65 percent of patients still start treatment without the recommended biomarker testing needed for their use, according to a study presented in JCO Precision Oncology, a medical journal published by the American Society of Clinical Oncology.

The primary barrier limiting patient access to targeted treatments is the lengthy turnaround time of current genetic sequencing-based solutions, typically weeks from diagnosis.

"Due to the length of time it takes for current methods of testing to return actionable results, clinicians are faced with the impossible choice of waiting for NGS (next-generation sequencing) results before starting non-small cell lung cancer therapy or prescribing what could be sub-optimal therapy for our patients," said Kashyap Patel, M.D., chief executive officer of Carolina Blood and Cancer Care, an oncology clinic in Rock Hill, S.C., and immediate past president of Community Oncology Alliance, a national non-profit organization that advocates for community oncology practices and their patients. "It's time we overcome the complexity and inefficiency of testing that is limiting the potential survival advantage of precision medicine."

ASPYRE-Lung eliminates this barrier by providing comprehensive biomarker test results across all guideline-recommended genes for non-small cell lung cancer within days of diagnosis, according to Biofidelity.

ASPYRE-Lung is the first application of Biofidelity’s patented molecular biology technology platform, which uses a unique enzymatic reaction to dramatically accelerate the detection of actionable biomarkers from blood or tissue within hours. The lung assay can simultaneously analyze 77 DNA mutations and 37 RNA fusions, according to the company’s website.

The ASPYRE platform is an alternative technology to PCR (polymerase chain reaction) and next-generation RNA and DNA sequencing methods commonly used in cancer analysis. With the ability to harness existing instrumentation commonplace in laboratories worldwide, ASPYRE provides cost-effective access to the information needed for accurate targeting and monitoring of cancer treatment, according to Biofidelity.

"As a patient advocacy organization, we believe access to comprehensive biomarker testing is very important to advancing cancer care," said Paige Humble, chief executive officer of the Raleigh-based Lung Cancer Initiative, a non-profit organization that supports research, education and treatment access. "Everyone who is diagnosed with lung cancer deserves access to the best treatment available, and we support efforts to improve access and the time that it takes for patients to receive actionable results."

Founded in 2019 in Cambridge, England, Biofidelity is staffed by scientists, engineers, physicians and business experts committed to bringing the benefits of genomics-based precision medicine to patients around the world.