Biofidelity launches lung reagent for integrated tissue and liquid biopsy analysis

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Biofidelity has launched its Aspyre Lung Reagents molecular diagnostic assay for identifying non-small cell lung carcinoma (NSCLC) biomarkers in both DNA and RNA from tissue and blood samples.

The company's allele-specific pyrophosphorolysis reaction (ASPYRE) technology is designed for simplified genomic profiling, according to its commercial study published September 25 in Frontiers in Oncology.

The assay assesses the status of 114 actionable variants across 11 genes from paired DNA (20 ng) and RNA (6 ng) derived from formalin-fixed paraffin-embedded (FFPE) lung tissue in a single workflow, according to details in Frontiers. Furthermore, the fluorescent output from the quantitative polymerase chain reaction (qPCR) instrument is analyzed through ASPYRELab cloud-based software to provide variant call results for each sample, including assay and sample quality checks, the authors wrote.

Aspyre may be useful for faster, more affordable PCR and qPCR testing as an alternative to next-generation sequencing for analyzing multiple variations from a single sample, according to Biofidelity. The company specified that Aspyre Lung Reagents are for research use only.

"An accessible liquid biopsy platform that can be easily validated and implemented in laboratories globally without the need for investment in new equipment and bioinformatics will undoubtedly lead to a fundamental paradigm shift enabling broader access to genomic testing,” stated Biofidelity Vice President of Medical Affairs Dr. Jeff Gregg in the company's announcement. 

Biofidelity operates facilities in Cambridge, U.K., and Research Triangle Park in and near Raleigh, NC. 

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