COMPANY:

Biofidelity

"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."

"Biofidelity...to announce the establishment of a manufacturing facility dedicated to genomic assay production in the UK...It will be used to produce the company’s ASPYRE products as well as serving as a hub for manufacturing innovation, allowing Biofidelity to produce cutting-edge genomic assays for global distribution and contribute to the growth of the local biotech sector."

"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."

"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."

"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)."

"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...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."