CAMBRIDGE, UK and RESEARCH TRIANGLE PARK, NORTH CAROLINA, USA/ February 20, 2025/, 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 911���ϰ����� 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.

911���ϰ����� will present Enspyre proof of concept data at the 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 911���ϰ�����’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.  

911���ϰ����� 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 911���ϰ�����

911���ϰ����� 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 .

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Customer Service

info@biofidelity.com

Aspyre Lung simplifies the detection of established non-small cell lung cancer (NSCLC) biomarkers by analyzing both DNA and RNA from tissue and blood using a streamlined four-step workflow. Designed to run on existing qPCR platforms, it integrates seamlessly into laboratories globally and aligns with CellCarta’s mission to support global clinical trials through innovative genomic services.

Under the terms of the strategic partnership agreement, CellCarta will set up and validate Aspyre Lung in their European laboratories first, followed by its US-based laboratories and will have non-exclusive rights to utilize Aspyre Lung for clinical trials globally. The partnership provides customers with revolutionary services leveraging both liquid and tissue biopsy samples, helping accelerate and facilitate rapid and reliable clinical trial enrollment. 

“We are extremely pleased to enter into this strategic partnership with CellCarta to expand the use of Aspyre Lung to global clinical trials,” said 911���ϰ����� Co-Founder and CEO Barnaby Balmforth, PhD. “At 911���ϰ����� we’re actively working toward a future where more people around the world have access to the life-changing power of genomics. Partnering with CellCarta to make clinical trial enrollment faster and more efficient utilizing Simplified Genomic Profiling (SGP) via Aspyre Lung moves us significantly forward toward fulfilling our mission.”

“We are excited to embark on this partnership with 911���ϰ�����,” said CellCarta CEO Dusty Tenney. “CellCarta offers an extensive portfolio of biomarker testing services and tailored solutions for the pharmaceutical and biotech industry. The addition of Aspyre Lung to our capabilities marks an advancement in our mission to propel precision medicine with specialized laboratory services.”

To learn more about 911���ϰ�����’s Aspyre Lung, visit biofidelity.com/products/aspyre-lung-reagents/

To learn more about CellCarta’s global CRO capabilities, visit

About 911���ϰ�����

911���ϰ����� 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 and .

About CellCarta

CellCarta is a leading global CRO laboratory to the biopharmaceutical industry. With CAP accreditations and CLIA certifications for specific testing methods and facilities in Canada, USA, Belgium, Australia, and China, CellCarta provides a wide range of biomarker testing services and customized solutions to world-renowned pharmaceutical companies. By integrating analytical platforms in immunology, histopathology, proteomics, and genomics, along with sample management and logistics services, CellCarta supports the entire drug development cycle from discovery to late-stage clinical trials. Visit and connect with us on and .

911���ϰ�����

911���ϰ�����
Customer Service
info@biofidelity.com

CellCarta
Stéphanie Bussières-Marmen
stephanie.marmen@cellcarta.com

Grant funds will be used to achieve Green Lab Certification for the Company’s Cambridge-based laboratories

Cambridge, UK – 17 December 2024/– , a leader in innovative genomic solutions, is proud to have been selected as a grant recipient by the Green Business Impact Programme, a collaborative effort led by Cambridge City Council, South Cambridgeshire District Council, Huntingdonshire District Council, the Cambridgeshire and Peterborough Growth Hub and the Cambridgeshire & Peterborough Combined Authority and administered by Allia Impact, Ltd.

911���ϰ����� will use the grant to achieve My Green Lab certification for its Cambridge-based laboratories. My Green Lab Certification is considered the gold standard for laboratory sustainability best practices around the world. The certification program utilizes sustainability standards for laboratories that have been adopted by thousands of labs and hundreds of institutions around the world. These certification standards seek to reduce the environmental impact of laboratories in four key areas: energy, water, waste, and chemical use, through a combination of organizational initiatives and behavior change programs. 911���ϰ�����’s certification process will begin in December 2024 and run through 2025 until the criteria for certification is met. 

The grant was awarded to 911���ϰ�����’s employee-led, leadership-supported Environmental Impact Committee (EIC). The EIC seeks to improve the environmental responsibility of 911���ϰ�����’s operations and products with the goal of making the Company a leading example of effective environmental responsibility in our industry. The EIC’s work is strategically aligned with two of the United Nations Sustainable Development Goals: Goal 12: Responsible Consumption and Production and Goal 13: Climate Action. 

“911���ϰ����� is committed to advancing sustainability efforts including green office and lab efforts via a range of initiatives sponsored by the Environmental Impact Committee”, said 911���ϰ�����’s Associate Director of Project Management and EIC Member, Marion Richardson. “Achievement of My Green Lab Certification will empower our scientists to make choices that not only benefit their research but also the environment and our community while helping to build a culture of sustainability in our laboratories. We are grateful to the Green Business Impact Programme for this grant and the opportunity to achieve this distinguished certification.” 

Through the Green Business Impact Programme, 911���ϰ����� was given the opportunity to work with PECT, an environmental sustainability charity, to develop a five-year Net Zero roadmap. While the My Green Lab Certification will be the main focus of the Company’s Net Zero roadmap for the foreseeable future, the EIC is committed to working on other areas identified in the roadmap to further 911���ϰ�����’s sustainability goals per our commitment to the Cambridge Climate Change Charter.

About 911���ϰ�����

911���ϰ����� 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  and .

911���ϰ�����

Customer Service
info@biofidelity.com

“These studies demonstrate that Aspyre Lung solves many of the insurmountable issues that exist with current molecular testing methods, while delivering consistent and reliable results from challenging samples, ” said 911���ϰ����� Co-Founder and CEO Barnaby Balmforth, PhD. “Aspyre Lung is an entirely new category of molecular testing, Simplified Genomic Profiling (SGP) that provides simplicity, speed, reliability and ease of adoption.” 

Aspyre Lung: Validation of a simple, fast, robust and novel method for multi-variant genomic analysis of actionable NSCLC variants in FFPE tissue in Frontiers in Oncology, demonstrates 100% concordance between Aspyre Lung and NGS, with 100% sensitivity and specificity even at low tumor content. The limit of detection was determined to be <3% variant allele fraction for DNA variants, and <100 copies for RNA fusions. The results were highly reproducible across operators, reagent lots, runs and real-time PCR instruments with a high degree of precision. 

Evaluation of the Aspyre Lung targeted variant panel: A rapid, low-input solution for NSCLC biomarker testing and experience from three independent sites in Translational Lung 911���ϰ����� Research demonstrates that Aspyre Lung Reagents can be easily set up and run at external laboratories within a few days, producing reliable results even from challenging sample types. Nucleic acid derived from 77clinical samples was tested across three sites including 911���ϰ�����, the Hospital of the University of Pennsylvania and the Precision Medicine Laboratory at the Medical College of Wisconsin. The samples included FFPE tissue, peritoneal and pleural effusions , fine needle aspirates (FNA), FNA rinses, and fresh tissue. The results were then compared between sites and to orthogonal next generation sequencing-based methods. 

A comparison of Aspyre Lung results across the three sites gave 100% positive percent agreement (PPA) and 99.99% negative percent agreement (NPA). Further, a comparison of Aspyre Lung results to NGS results gave a PPA of 96.2% and NPA 99.97%. Aspyre Lung consistently yielded results from challenging cytology samples, with 100% PPA and 99.93% NPA. 

The data also highlight that the sensitivity of Aspyre Lung enables the detection of variants that may be missed using current approaches, which has significant implications in both the clinical and research settings. 911���ϰ����� identified a ROS1 gene fusion in one sample across three different sites which was not detected by NGS. Subsequent retesting using another orthogonal method gave a result in agreement with Aspyre Lung, indicating a false-negative with the original orthogonal method. 

To learn more about Aspyre, please visit biofidelity.com

About 911���ϰ�����

911���ϰ����� 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 and .

New data to be presented at ISLB 2024 demonstrates best-in-class liquid biopsy clinical performance 

CAMBRIDGE, UK and RESEARCH TRIANGLE PARK, NORTH CAROLINA, USA, November, 21, 2024/ , a leader in innovative genomic solutions, 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.

“Currently, patients who are fortunate enough to receive molecular testing often have to wait weeks for the results, with many tests failing altogether,” said 911���ϰ����� Co-Founder and CEO Barnaby Balmforth, PhD. “Aspyre Clinical Test for Lung’s unmatched next day turnaround time coupled with its best-in-class performance from tissue and blood and proven performance with challenging samples makes Simplified Genomic Profiling (SGP) via Aspyre a game-changer for patients and the clinicians treating them.” 

Utilizing either tissue or blood samples, Aspyre Clinical Test for Lung detects somatic mutations from DNA and gene fusions directly from RNA, maximizing the ability to identify mutations and fusions, while avoiding the extra time, additional sample requirements and added expense of running separate assays.

Data supporting the launch will be presented at the International Society of Liquid Biopsy Annual Congress, November 23-25, 2024 in Denver, Colorado during the scientific poster session.

The poster, “Aspyre Lung Blood: Validation Of A Simple, Fast and Robust Method For Molecular Profiling Of Actionable Variants In Plasma,” will be presented on Saturday, November 23, from 11am-12:30 pm Mountain. Poster Number 182 (Clinical Applications of Liquid Biopsy).

“As a practicing oncologist, it is incredibly frustrating to see time and time again, patients with advanced and metastatic lung cancer being initiated on suboptimal therapy due to the lack of timely biomarker test results. This has most likely led to poorer outcomes and potentially reduced patient tumor response and survival,” said Dr. Steven Wong, a prominent medical oncologist who practices in several oncology practices across Southern California. “We always want to provide our patients the best treatment possible. Having the option to analyze both blood and tissue samples, DNA and RNA via a simple, fast and reliable test will undoubtedly enable broader access to genomic testing and ultimately better outcomes for patients. Using the most optimal therapy is the most cost effective way to manage patients with cancer.”

To learn more about Aspyre Clinical Test for Lung, please visit biofidelity.com/clinical-testing

About 911���ϰ�����

911���ϰ����� 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 and .

911���ϰ�����

Customer Service
info@biofidelity.com

Fast, simple, decentralized testing from tissue and blood using standard PCR instruments

New data to be presented at AMP 2024 demonstrates best-in-class tissue and blood performance from both DNA and RNA 

CAMBRIDGE, UK and RESEARCH TRIANGLE PARK, NORTH CAROLINA, USA, November, 14, 2024/ , a leader in innovative genomic solutions, 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.

“Until now there has not been an alternative to next-generation sequencing (NGS) to provide fast, simple, decentralized testing for NSCLC biomarkers,” said 911���ϰ����� Co-Founder and CEO Barnaby Balmforth, PhD. “Aspyre Lung’s best-in-class performance from tissue and blood coupled with its proven performance with challenging samples makes Simplified Genomic Profiling (SGP) via Aspyre Lung a game-changer for laboratories globally.” 

Data supporting the launch will be presented at the Association for Molecular Pathology Annual Meeting & Expo November 19-23, 2024 in Vancouver, British Columbia, Canada.

Poster, “Development of a machine learning model for Aspyre Lung (Blood): a new assay for rapid detection of actionable variants from plasma in NSCLC patients” will be presented on Saturday, November 23, from 9:15am – 10:15 am Pacific. Poster Number I021 (Informatics), Abstract 1870825.

Additionally, 911���ϰ����� will host an Innovation Spotlight at the AMP Conference on Friday, November 22, at 12:40 pm Pacific entitled “Aspyre Lung: Simplified Genomic Profiling: A faster, simpler, decentralized alternative to NGS”, presented by Dr. Jeff Gregg, 911���ϰ����� Vice President of Medical Affairs.

“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,” said Dr Gregg.

To learn more about Aspyre Lung, please visit biofidelity.com

About 911���ϰ�����

911���ϰ����� 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 and .

Lee Anderson joins 911���ϰ����� to expand the adoption of Aspyre Lung, a completely new category of molecular diagnostic that fulfills an acute unmet clinical need for people with non-small cell lung cancer and the clinicians who treat them

CAMBRIDGE, UK and RESEARCH TRIANGLE PARK, NORTH CAROLINA, USA, October 17, 2024 – 911���ϰ�����, a revolutionary genomic technology company, today announced the appointment of Lee Anderson as Chief Commercial Officer. With more than 30 years of expertise in biotechnology and diagnostic oncology, Lee brings a wealth of experience from several start-up companies and successful new product launches. 

“We are excited to welcome Lee to 911���ϰ����� during this pivotal time,” said Dr. Barnaby Balmforth, Co-Founder and CEO of 911���ϰ�����. “His deep expertise in the oncology space and proven ability to lead high-performing commercial teams will be instrumental as we continue to push the boundaries of genomics and transform cancer care.” 

Prior to joining 911���ϰ�����, Lee spent 15 years at Genomic Health, where he helped launch Oncotype DX and served as Vice President of Sales and Global Customer Service. After Genomic Health’s acquisition by Exact Sciences, he led the commercial integration and later served as General Manager of the Precision Oncology business unit, overseeing new diagnostic product launches.

In addition to his corporate roles, Lee has served on the advisory board of Florida State College’s Department of Biological Sciences, contributing to the development of their Biomedical Science Degree program.

About 911���ϰ�����

911���ϰ����� 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 and .