Introducing Aspyre Clinical Test: A breakthrough in lung cancer testing

With more than 2.2 million new cases diagnosed each year, lung cancer is the 2nd most common cancer in the world, and the leading cause of cancer deaths. In the US alone it is estimated that 238,000 patients will be diagnosed in 2023.  

Great advances have been made in the treatment of lung cancer, resulting in the FDA approval of a multitude of new life saving therapies, including more than 25 which target specific genomic mutations in a patient’s tumor. Unlike toxic, broad spectrum, chemotherapies that penetrate every cell in the body, these targeted therapies selectively address only those cells that are affected by cancer.

As a result of these advances, selecting the right therapy for each patient requires the profiling of a patient’s genome to detect the presence of the genomic changes, or biomarkers, that will respond to treatment. 

The current standard-of-care technology for biomarker testing is next-generation sequencing (NGS), but unfortunately this approach comes with significant drawbacks. NGS remains highly complex, can take 3-5 weeks to yield an answer, and frequently fails to obtain a result at all. These challenges are the primary reasons why 65% of patients with lung cancer begin therapy without the crucial information needed to ensure the best treatment.  

Although NGS has the capability to analyze hundreds of genes, the vast majority of the biomarkers identified do not have clinical relevance. For lung cancer, selection of targeted therapy is dependent on the analysis of only a small number of genes which harbor targetable mutations and are recommended for testing by the National Comprehensive Cancer Network (NCCN) guidelines. Fast access to this actionable information is vital for effective patient care.

At Biofidelity we discovered a simpler, faster, and more efficient way to identify mutated DNA and RNA, and have used this technology to develop a unique product, Aspyre Clinical Test for Lung. 

Rather than searching for the needle in a haystack, Aspyre Clinical Test for Lung starts with the needle, using synthetic probes to target 114 specific genomic alterations that correlate with targeted therapies. These highly specific probes are activated and detected only if mutations are present in a patient sample, allowing the detection of clinically actionable biomarkers at high sensitivity. 

Aspyre Clinical Test for Lung is as sensitive and specific as NGS, with 100% positive and negative predictive accuracy demonstrated across both DNA and RNA. It provides simple to interpret information across all guideline recommended genes. And most importantly it provides this information quickly, with next day results enabling physicians to make rapid treatment decisions for patients who desperately need it.

We’re excited to have launched Aspyre Clinical Test for Lung as a laboratory developed test through our CLIA certified laboratory in North Carolina, and to deliver on Biofidelity’s mission to bring the benefits of precision medicines to many more patients. 

For more information, please visit our website at www.biofidelity.com 

Written by Barnaby Balmforth, PhD, Biofidelity Co-founder and CEO