TEST:

ASPYRE-Lung

Concordance with next-generation sequencing (NGS)-based methods across all three sites was high with PPA of 97.2% and NPA of 99.96%. ASPYRE-Lung assay is a cost-effective, easy to adopt testing method requiring no specialized expertise or complicated bioinformatics, with the potential to inform genomic data on small tissue samples, thus enabling all patients with NSCLC to undergo biomarker testing in a timely manner and benefit from appropriate targeted therapies.

"Biofidelity...announced the publication of data that highlights how Aspyre® technology addresses the urgent need for rapid, accessible molecular diagnostics informing actionable genomic variants in cancer."

"Biofidelity...today announced the launch of Aspyre Clinical Test for Lung for liquid biopsy samples. Aspyre Clinical Test for Lung analyzes all guideline-recommended genes for non-small cell lung cancer (NSCLC) patients in both DNA and RNA from tissue and blood within two days, benefitting patients by enabling earlier treatment decisions."

"Biofidelity...today announced the launch of Aspyre Lung Reagents (research use only) for liquid biopsy samples. Aspyre Lung identifies established non-small cell lung cancer (NSCLC) biomarkers in both DNA and RNA from tissue and blood in a single straightforward, four-step workflow and runs on existing qPCR platforms, enabling simple integration into laboratories globally."

These data support further clinical testing using the best performing model and development of ASPYRE-Lung blood for liquid biopsy samples.

The technology is simple and fast, requiring only four reagent transfer steps using standard laboratory equipment (PCR and qPCR instruments) with analysis via a cloud-based algorithm. The ASPYRE-Lung assay has the potential to be transformative in facilitating access to rapid, actionable molecular profiling of tissue for patients with non-small cell carcinoma.

Sponsored by Biofidelity.Learn how the ASPYRE-Lung comprehensive lung panel enables 2-day testing of all NCCN guideline recommended genomic biomarkers associated with targeted therapies for NSCLC on both DNA and RNA.

"Biofidelity...successfully completed a financing round totalling $24 million bringing total funding raised since the Company was founded in 2019 to $60 million...The latest round of financing will accelerate the growth of the Company, including commercial and clinical expansion in the United States to accelerate the adoption of ASPYRE®-Lung, a novel test that dramatically simplifies and accelerates the detection of biomarkers for non-small cell lung cancer (NSCLC), enabling clinicians to determine which treatment is best for each patient in days instead of weeks and at a fraction of the cost of current sequencing tests."

The technology is simple and fast, requiring only four reagent transfer steps using standard laboratory equipment (PCR and qPCR instruments) with analysis via a cloud-based analysis algorithm. ASPYRE-Lung has the potential to be transformative in facilitating access to rapid, actionable molecular profiling of tissue for patients with NSCLC.

Together, these results demonstrate high concordance of ASPYRE-Lung and NGS across different types of clinical samples, alongside ease of adoption of the ASPYRE-Lung assay with simple training and no specialist expertise required. ASPYRE-Lung promises to enable all patients with NSCLC to start appropriate treatment in a cost-effective and timely manner.

Samples were tested by ASPYRE-Lung using an input of 20 ng DNA and 6 ng RNA, except for 5 patient samples that were run at lower inputs, ranging from 4.25 to 14 ng DNA.Key findings:•Of the 94 patient samples that failed NGS QC, 98% of samples (92/94) passed ASPYRE-Lung QC and could inform patient care.•In the 92 patient samples that passed ASPYRE-Lung QC, 47% (43/92) had a detectable variant identified by ASPYRE-Lung.•All 26 control samples that passed NGS QC also passed ASPYRE-Lung QC.•Of the 5 samples with 4.25 to 14 ng DNA inputs to ASPYRE-Lung, data were generated on 4/5 samples and 2/4 had a detectable variant.•ASPYRE-Lung has the potential to provide actionable clinical information on patient samples deemed to be of insufficient quantity for NGS testing.ASPYRE-Lung has a high success rate, is easily adoptable and cost effective making it suitable as a first-line testing option, or for samples that are either QNS or fail NGS QC, and can provide a large fraction of NSCLC patients with actionable biomarker information, with potentially smaller tissue requirements. ASPYRE-Lung genomic testing is transformative for cancer care management, and allows more patients with NSCLC to benefit from effective and better tolerated therapies.

"Diagnostics firm Biofidelity and government distributor Fidelis said Wednesday that they have made a deal to make Biofidelity's ASPYRE-Lung test available to VA medical centers and active military institutions across the US."