Biofidelity Ltd.

Enspyre is a next generation sequencing (NGS) preparation technology enabling higher sensitivity variant calling from a fraction of the data CAMBRIDGE, England and RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2025 /PRNewswire/ -- Biofidelity, a leader in innovative genomic solutions, will present launch details for Enspyre®, a novel target enrichment technology with a broad spectrum of potential applications that allows for selective enrichment of specified variants prior to sequencing. "NGS is highly inefficient – with as few as one in 20 million sequenced bases resulting in a variant call. This results in poor signal to noise, severely limiting the potential of NGS that even AI will never unlock," said Biofidelity Co-founder and CEO, Barnaby Balmforth, PhD. "Enspyre removes up to 99% of background DNA prior to sequencing, enabling high throughput NGS applications on benchtop sequencers. This cracks wide open the potential for new applications of NGS across clinical use and research science." Enspyre ( Enrichment by selective pyrophosphorolysis and release) redefines what is possible with NGS by dramatically enhancing signal to noise, enabling the identification of variants with a sequencing depth reduced by more than 95% compared to a non-selective assay. This presents the opportunity to transform a broad spectrum of potential applications within oncology, including minimum residual disease (MRD) testing, and beyond. Additional benefits include lower data processing time and significantly decreased data storage requirements. Cumulatively, these benefits could significantly improve sensitivity, bring down the cost of sequencing necessary for MRD detection, and deliver results significantly faster for patients. Biofidelity will present Enspyre proof of concept data at the Advances in Genome Biology and Technology (AGBT) General Meeting in Marco Island, Florida, February 23-26. The poster (#434) entitled: Enspyre: A novel enrichment technology for selected DNA variants using pyrophosphorolysis will be presented on Tuesday, February 25, 2025 from 4:45-6:10pm EST. Enspyre technology is complementary to Biofidelity's PCR-based Aspyre® technology and the commercially available Aspyre® Lung product which enables fast, simple, decentralized testing for non-small cell lung cancer biomarkers in tissue and blood. Together, these two technologies enable a pipeline of products to be purpose-built to meet critical unmet needs throughout oncology. Biofidelity is taking an 'Intel Inside' approach to making Enspyre commercially available. The company is actively pursuing partnering and licensing opportunities with multiple global pharmaceutical companies, contract research organizations (CROs) and precision medicine drug developers. To learn more about Enspyre, please visit biofidelity.com/products/enspyre About Biofidelity Biofidelity is a rapidly growing commercial-stage genomic technology company dedicated to improving and extending the lives of patients with cancer by enabling better targeting of therapies, early detection of treatment resistance and routine monitoring of treatment response. Visit biofidelity.com and connect with us on LinkedIn. Contact Andrea Conners +1 239-728-1202 [email protected] SOURCE Biofidelity WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASPYRE-Lung addresses critical gaps in NGS-based biomarker testing: Late Breaking Abstract data demonstrate 98% of NGS QC fails can be rescued CAMBRIDGE, England and RESEARCH TRIANGLE PARK, N.C., April 5, 2024 /PRNewswire/ -- Biofidelity, a revolutionary genomic technology company dedicated to bringing the benefits of precision medicine to patients around the world, announced that new data from its breakthrough product ASPYRE-Lung will be presented in three scientific posters, including a Late Breaking Abstract (LBA), at the upcoming American Association for Cancer Research (AACR) 2024 Annual Meeting, April 5-10, in San Diego, CA. Continue Reading LBA poster, "ASPYRE-Lung addresses critical gaps in NGS-based biomarker testing: Robust variant calling from NGS QC fails" will be presented on Monday, April 8, 2024 from 9:00 AM - 12:30 PM PDT in Poster Section 51, Abstract LB095*. Data demonstrates that ASPYRE®-Lung addresses critical gaps in NGS-based non-small cell lung cancer biomarker testing Post this Poster, "Deployment of ASPYRE-Lung targeted variant panel across three sites and testing with FFPE tissue and cytology-derived nucleic acid samples" will be presented on Tuesday, April 9, 2024, from 9:00 AM - 12:30 PM PDT in Poster Section 45, Abstract 5164*. Poster, "ASPYRE-Lung: Validation of a simple, fast, robust and novel method for multi-variant genomic analysis of actionable NSCLC variants in tissue" will be presented on Wednesday, April 10, 2024 from 9:00 AM - 12:30 PM PDT in Poster Section 45, Abstract 7622*. "NGS test failure is a major challenge, with as many as 25% of samples failing NGS due to quality control (QC) issues, and a major contributor to inadequate patient care in more than half of lung cancer patients in the US1," said Biofidelity Co-Founder and CEO Dr Barnaby Balmforth. "Through our study of commercially biobanked non-small cell lung cancer (NSCLC) patient samples, we have demonstrated that ASPYRE-Lung is able to address critical gaps in NGS-based NSCLC biomarker testing." "We were able to generate clinical reports covering all guideline recommended NSCLC biomarkers for 98% of samples that failed NGS QC using ASPYRE-Lung," said Biofidelity Chief Medical Officer Dr Wendy Levin, MD, MS. "As an oncologist, the ability to deliver results within two days to patients who would otherwise not have received results with which to guide their therapy selection is a true breakthrough for patients and the clinicians who treat them." For more information and to download the white paper, "ASPYRE®-Lung addresses critical gaps in NGS-based biomarker testing: robust variant calling from NGS QC fails," click here. *Full abstracts (with the exception of LBAs) are available on the AACR website. LBAs will be available on April 5th. The posters will be available on Biofidelity's website. About Biofidelity Biofidelity is a rapidly growing commercial-stage genomic technology company dedicated to improving and extending the lives of patients with cancer by enabling better targeting of therapies, early detection of treatment resistance and routine monitoring of treatment response. Visit biofidelity.com and connect with us on LinkedIn and X. Contact Andrea Conners [email protected] 1 Hagemann et al., 2015, Sadik et al., 2022 SOURCE Biofidelity

ASPYRE-Lung Research Use Only (RUO) reagents enable localized testing and rapid results across all NCCN guideline recommended genes for non-small cell lung cancer (NSCLC). CAMBRIDGE, England and RESEARCH TRIANGLE PARK, N.C., Dec. 6, 2023 /PRNewswire/ -- Biofidelity today announced the commercial launch of its ASPYRE®-Lung RUO reagent product. ASPYRE-Lung RUO reagents enable localized testing & rapid results across recommended genes for NSCLC 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. Learn more about ASPYRE-Lung RUO here. "Following the recent launch of the ASPYRE-Lung Laboratory Developed Test (LDT) we are excited to quickly deliver our reagent solution to customers for research use," said Barnaby Balmforth, PhD, Biofidelity Co-founder and CEO. "Both launches represent a major step toward decentralizing genomic testing and enabling enhanced access to critical biomarker testing through our CLIA laboratory and research customers." ASPYRE-Lung RUO solves key issues that create barriers to biomarker testing. ASPYRE runs on existing PCR instruments already available in laboratories around the world, and can be rapidly implemented without new laboratory staff, sample batching, or complex bioinformatics. ASPYRE's high sensitivity enables testing from tissue samples with as little as 10% tumor content, compared to 20% or 30% for most competing assays. And critically, ASPYRE enables fast analysis of comprehensive panels of genomic biomarkers without the need to send samples to a centralized lab, which often takes weeks to obtain results, allowing labs to maintain control of valuable samples. Customers are eager to internalize rapid precision diagnostics. "At Athena Esoterix we're honored to serve a diverse group of clients, all of whom require high-quality diagnostic testing with rapid turnaround", said Elizabeth Forrester, PhD, Athena Esoterix Founder and Technical Director. "ASPYRE-Lung RUO will help us enable our physician customers to provide rapid input into their research projects." About Biofidelity Biofidelity is a rapidly growing commercial-stage genomic technology company dedicated to bringing the benefits of precision medicine to patients around the world. ASPYRE®, the first application of our novel molecular biology technology platform, makes genomic analysis simpler, faster, and more efficient. With the ability to harness existing instrumentation commonplace in laboratories worldwide, ASPYRE provides straightforward, cost-effective access to the vital information needed for accurate targeting and monitoring of cancer treatment. Visit biofidelity.com and connect on LinkedIn and X. Contact Andrea Conners +1 239-828-1202 media@biofidelity.com