TEST:

ASPYRE-Lung

"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."

"Biofidelity...announced the commercial launch of its ASPYRE®-Lung RUO reagent product. ASPYRE-Lung dramatically simplifies and accelerates the detection of genomic biomarkers, enabling localized testing at a fraction of the cost of current sequencing tests, with results available in days instead of weeks."

"Biofidelity...today announced the commercial launch of ASPYRE®-Lung in the US....ASPYRE-Lung is a novel assay 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 at a fraction of the cost of current sequencing tests, in days instead of weeks."

"Biofidelity...announced that an abstract of data from its breakthrough ASPYRE technology will be shared at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-6 in Chicago, IL, USA...The abstract 'Analytical performance assessment of ASPYRE-Lung: A new assay for rapid detection of actionable variants from tissue and plasma in NSCLC patients' is available in the ASCO meeting publication published today as abstract number e15038."

The data show that ASPYRE-Lung meets or exceeds target specifications for the detection of single nucleotide variants (SNVs), insertions/deletions (indels), and gene fusions. Estimates of LoD for key variants fall within target specifications, and assay-wide performance demonstrates highly sensitive detection of each class of variant. Performance was similar at the two laboratory sites further supporting the clinical potential of the assay.

"Biofidelity, a revolutionary genomic technology company, announced that new data from its breakthrough ASPYRE technology will be presented in a scientific poster at the upcoming Association for Molecular Pathology 2022 Annual Meeting, Nov. 1-5, in Phoenix, Ariz...The ASPYRE technology is used to create targeted, multi-gene biomarker panels that are ultra-sensitive, highly specific, and capable of returning results in as little as two days. Using the technology, Biofidelity has developed ASPYRE-Lung, a cost effective, simple and rapid assay that enables detection of multiple genomic biomarkers for patients diagnosed with non-small cell lung cancer (NSCLC)."

We describe validation of a novel method for detecting a panel of clinically actionable NSCLCassociated mutations and RNA fusions from FFPE tissue or plasma. The simple workflow includes four steps that involve only reagent transfer and incubation. The assay is robust and precise with performance characteristics approaching that of next-generation sequencing, but with faster turnaround times, lower complexity workflows, simple bioinformatic analysis, reduced cost, and with no variant of uncertain significance-type variants to interpret.

"Biofidelity, a revolutionary genomic technology company, has developed a low-cost, simple and rapid assay for single-molecule detection of multiple gene fusions from RNA. A new scientific paper describes the assay and how detecting these fusions faster and at a lower cost has the potential to revolutionize patient care and make precision medicine globally accessible to more people...Published online in BMC Medical Genomics, the paper expands on a previous scientific report introducing the technology and details the RNA capabilities of ASPYRE®, which can analyze DNA and RNA concurrently from a single patient sample."

"Biofidelity...announced today the issuance of several new patents in the US, Europe, and China. The patents further strengthen the Company’s intellectual property position and the protection of the technology underpinning its first commercial product, ASPYRE-Lung®....Newly issued European patent EP3842549 will provide protection for ASPYRE until 2040 in key European countries."

Biofidelity’s breakthrough ASPYRE technology enables a dramatic simplification of workflows, and the ultra-sensitive detection of actionable biomarkers using existing real-time PCR instruments. This work has demonstrated the ease with which independent laboratories can implement comprehensive multi-gene assays based on ASPYRE technology, utilizing their existing staff and infrastructure. This stands in stark contrast to alternative solutions, which typically require substantial investments in new instrumentation, skilled staff, IT infrastructure and bioinformatics.

"Biofidelity...has successfully completed a heavily oversubscribed $23 million Series A+ investment round, led by Octopus Ventures and backed by SBI Investment Co. Ltd. and existing investors. The investment will fund the upcoming launch of ASPYRE-Lung, the company’s first commercial diagnostic assay based on its breakthrough molecular technology."