Atomo Diagnostics Limited (Atomo) and BBI are pleased to announce that they have entered into a strategic business arrangement under which both parties have agreed to share business development efforts to bring together their unique and complimentary technology, knowhow and IP in order to meet their customers’ rapid diagnostics needs.

By combining the offering of Atomo’s unique fully integrated rapid test platforms with BBI’s deep expertise in lateral flow assay development, manufacturing, and digital app solutions, the parties are able to build on their successful existing partnership. The non-exclusive agreement will allow both parties to offer full design, development and production solutions to those looking to bring new tests to market, and expand existing portfolios, as the rapid diagnostics market continues to grow and evolve post-pandemic.

Atomo CEO John Kelly said “Atomo and BBI have had the opportunity to work together in the past and this extended agreement seeks to strengthen the relationship such that both parties can reach a broader audience, particularly in the UK and Europe and Asia-Pacific where BBI has extensive business infrastructure, with a full-service rapid diagnostics solution. This is a tremendous opportunity for us to accelerate growth across international markets and a recognition by both parties of their unique skill sets being applicable to the growing consumer focused rapid test market where ease of use and app functionality are critical.”

BBI CEO Mario Gualano wrote “I am delighted that our relationship with Atomo continues to strengthen extending our flexible solutions to drive and deliver exceptional products for our customers evolving needs.  The opportunity to combine BBI’s expertise and commercial reach in lateral flow development and manufacture, and BBI’s patented NovarumTM digital technology, with the flexibility and quality of Atomo’s integrated platforms, creates value and offers an elegant solution for our customers”.

BBI are committed to constantly enhancing customers experiences with us. As part of that ethos, we are excited to announce a transformative initiative that will simplify and streamline the global ordering process for our customers, starting in January 2024. We call it ‘One BBI,’ and it’s designed to make your interactions with us more efficient and convenient.

The ‘One BBI’ project aims to consolidate your transactions with BBI into a single trading entity while ensuring that you have access to our full range of products and services across the globe. This initiative will offer you several benefits:

1: Simplified Accounts: With ‘One BBI,’ you will have the opportunity to streamline your accounts by dealing with a single trading entity within BBI.

2: Greater Convenience: If you currently transact with multiple BBI entities worldwide, such as BBI and Diarect GMBH in Germany, you will be able to choose the most convenient trading entity for your business needs. This change will not disrupt your access to the products you have already purchased.
3: Access to a Wider Portfolio: ‘One BBI’ will open up access to our complete product portfolio across all BBI global locations, providing you with a broader range of options to meet your requirements.

Our dedicated account managers are here to assist you throughout this transition. If you have any questions or would like to learn more about ‘One BBI,’ please do not hesitate to reach out to your account manager. They will be more than happy to discuss any inquiries you may have and guide you through the process.

We believe that ‘One BBI’ will significantly enhance your experience when dealing with us and improve the efficiency of your transactions. We value your partnership with BBI and look forward to serving you even better with ‘One BBI’ in the coming year.

If you have any questions, please reach out to your account manager, or you can contact our support team on info@bbisolutions.com.

BBI Solutions OEM Limited (“BBI”), a global leader in diagnostic assay development and ABCDx, a pioneer in brain injury diagnostics, are thrilled to announce the successful completion of the initial phase of their collaborative development program for the LVOCheck rapid test. The announcement comes as both companies finalize the feasibility phase of the project.

Development Program Overview

The collaboration between BBI and ABCDx has primarily focused on optimizing the assay for the detection of specific markers indicative of brain injuries, including H-FABP, NT-pro BNP, and D-Dimer. The test is designed to work on human whole blood samples and seeks to deliver a quantitative result.

Successful Onboarding and Feasibility Phases

Throughout the Feasibility Phase both companies worked collaboratively, developing comprehensive project plans, selection of critical raw materials, and assessments against ABCDx’s existing devices. This phase also included key milestones such as the selection of biologicals based on assay performance and clinical relevance.

Impact of collaboration

“Achieving this technical milestone is testament to the great partnership between ABCDx and BBI. The extensive knowledge and understanding from ABCDx of these brain biomarkers, and the depth of expertise from BBI in applying these biologicals to lateral flow, is the perfect recipe for success” said Mario Gualano, CEO of BBI.

“As we complete these critical initial phases, we are one step closer to offering a revolutionary product that could change the landscape of brain injury diagnostics,” said Prof. Jean-Charles Sanchez, Co-Founder and CEO of ABCDx. “This accomplishment is not only a technical milestone but also adds significant value to our ongoing Series A fundraising efforts.”

About BBI

BBI has been serving the global diagnostics industry for over 50 years and is the world’s largest independent producer of immuno-diagnostics reagents. Core competencies include a comprehensive suite of reagents with custom development options, lateral flow development, and diagnostic manufacturing services.

About ABCDx

Founded and headquartered in Geneva, Switzerland, ABCDx is committed to the democratization of data-driven diagnostics in the field of brain injuries.

Cizzle Biotechnology, the UK-based diagnostics company focused on developing a cost effective biomarker test to help detect early-stage lung cancer, is pleased to announce a strategic agreement with BBI, the world’s largest independent producer of immunodiagnostic reagents, to supply its first order of commercial propriety monoclonal antibodies. This collaboration is a significant milestone in Cizzle’s mission to commercialise its cost-effective biomarker test for early-stage lung cancer detection.

This initial order of CIZ1B commercial propriety monoclonal antibodies from BBI is crucial for advancing the clinical evaluation process, marking a vital step towards bringing the test to market. These antibodies will be manufactured at BBI’s ISO 13485-certified facilities and are expected to support up to 5000 assays for detecting the CIZ1B biomarker, which is strongly associated with early-stage lung cancer.
The antibodies produced will be used in a clinical evaluation of patients with suspicious indeterminant (undiagnosed) lung nodules for lung cancer with a major cancer centre in the USA. This evaluation is ahead of the planned rollout of commercial tests by the Company’s intended licensing partner in the USA, Cizzle Bio Inc (“BIO”). Additionally, this partnership supports the development of a point of care (“POC”) assay and the Company’s broader plans to explore the utility of CIZ1B for detecting other cancers.

Key Highlights:

• Partnership with BBI Solutions: BBI will manufacture commercial CIZ1B monoclonal antibodies.
  •    Certified Manufacturing: Production in ISO 13485-certified facilities ensures adherence to stringent quality standards.
  •    Sufficient Initial Supply: The first batch will support up to 5000 blood tests for the CIZ1B biomarker.
  •    Supporting Clinical Evaluation: The antibodies will facilitate clinical evaluations with a major US cancer centre, critical for confirming the presence of lung cancer in patients with indeterminate lung nodules identified by CT scans.

Commercialization and Regulatory Strategy

The antibodies being produced will support Cizzle’s ongoing commercialisation and regulatory strategy, including:
•    US CLIA accreditation: As announced on 17 June 2024, BIO aims to register its first US CLIA (Clinical Laboratory Improvement Amendments) accredited lab with the FDA (US Food and Drug Administration) for the CIZ1B LDT test in September 2024.
•    CLIA certification and product launch: BIO plan to achieve CLIA certification for the LDT in November 2024, with an anticipated product launch and insurer reimbursement code achievement by April 2025.
•    Point of Care (“POC”) development: Plans include developing a POC test for use in pharmacies, doctors’ offices, and by healthcare providers.
•    Expanded research: Continued R&D at the University of York to explore the utility of CIZ1B in detecting other cancers.

It is essential that reagents, including the Company’s monoclonal antibodies, meet strict regulatory requirements. The ISO standards (International Organization for Standardization) provide a platform to bring globally accepted standards together and in the case of medical devices, which includes in vitro diagnostics, ISO 13485 is the Quality Management System applicable to the regulatory requirements for a business operating in the medical device sector*. BBI will be producing the Company’s antibodies within their ISO13485 certified facilities for custom manufacture of antibodies.

*PUB100422_preview.pdf (iso.org)

Further Information

With nearly 5000 lives lost daily to lung cancer, largely due to the lack of a simple early detection test, Cizzle is dedicated to bringing its proprietary CIZ1B test to market as quickly as possible. This partnership with BBI is a pivotal step in providing reliable clinical results and developing a user-friendly point-of-care test.

The supply of the new commercial monoclonal antibodies will be used to provide clinical results on patients suspected to have early-stage lung cancer arising from CT scanning in the US cancer centre, developing a simple finger prick point of care test for the CIZ1B biomarker and continuing Cizzle’s work to determine the utility of the test for other cancers.

In addition, the Company’s ongoing assay development and clinical evaluations are supported by Cizzle’s renewed research and development contract with the University of York, announced on 17 June 2024. Subject to local ethical approvals, the new phase of work will provide clinical results on patients with suspected early-stage lung cancer arising from CT scanning at a leading US cancer centre.

Allan Syms, Executive Chairman of Cizzle Biotechnology, said: “We are making significant progress in bringing the company’s CIZ1B test to market. CIZ1B is highly associated with early-stage lung cancer and after extensive and dedicated research at the University of York, we are now at a point where the test will be made available to clinicians and patients to help in the drive to detect cancer early and as a result save lives. A key step in making the test commercial is to partner with a trusted global manufacturer with the skills, experience and first-class quality-assured facilities to produce reliable, robust and reproducible antibodies. Hence we are delighted to be partnering with BBI solutions to make our first batch of antibodies for use in clinical evaluations and trials, before rolling out the test across North America and importantly investigating whether CIZ1B is relevant in detection other cancers. I believe this is an inflection point in the Company’s development and now through working with BBI we have the capability to accelerate growth by being able to produce our essential antibodies at scale.”

Mario Gualano, CEO of BBI, added: “We are excited to partner with Cizzle Biotechnology in their mission to bring an innovative lung cancer detection test to market. Our expertise in producing high-quality immunodiagnostic reagents will ensure that Cizzle’s CIZ1B monoclonal antibodies meet the highest standards. We are proud to contribute to a project that has the potential to significantly improve early cancer detection and patient outcomes globally.”

Enquiries

Cizzle Biotechnology Holdings plc    Via IFC Advisory
Allan Syms (Executive Chairman)

Allenby Capital Limited    +44(0) 20 3328 5656
John Depasquale
George Payne

Novum Securities Limited    +44(0) 20 7399 9400
Colin Rowbury
Jon Bellis

IFC Advisory Limited    +44(0) 20 3934 6630
Tim Metcalfe
Florence Chandler

About Cizzle Biotechnology

Cizzle is developing a blood test to help in the early detection of lung cancer. The Company was spun out from the University of York, in 2006, around the work of Professor Coverley and colleagues and was admitted to the Standard segment of the main market of the London Stock Exchange in May 2021. Its test is based on the ability to detect a stable plasma biomarker, a variant of CIZ1 known as CIZ1B. Normal CIZ1 is a naturally occurring cell nuclear protein involved in DNA replication, and the targeted CIZ1B variant has been shown to be highly correlated with early-stage lung cancer. For more information, please see https://cizzlebiotechnology.com
You can also follow the Company through its twitter account @CizzlePlc and on LinkedIn.

About Cizzle Bio

Cizzle Bio Inc, a company registered in Texas USA, has been created by a group of high-net-worth individuals with a passion to improve cancer patient survival. Recognising that one of the main causes of poor survival rates for certain cancers, and in particular lung cancer, is because diagnosis is often when the disease is at an advanced state, there is an unmet need for a simple blood test that can be used to detect cancer early.

BIO is led by Bill Behnke, who has been pioneering Cizzle Biotechnology’s marketing activities in the USA and is an accomplished entrepreneur and performance-driven senior executive with an extensive background of success in funding and building healthcare businesses through direct sales, marketing, sales management, and business development. He is heavily engaged in charitable work for cancer, and served a nine-year tenure on the national board of the Leukemia and Lymphoma Society. He currently serves on the boards of the ASCO Foundation’s Conquer Cancer; the AYA Cancer Foundation; The Wheeler Group; Children’s Shelter of San Antonio; South Texas Blood and Tissue Center; and the Leukemia and Lymphoma Society.

About BBI

BBI Solutions stands at the forefront of the global immunodiagnostic reagents industry, leveraging over 5 decades of expertise in In Vitro Diagnostics (IVD). The company specializes in high-quality raw materials and custom development solutions, supporting lateral flow test development and manufacturing. The company’s ISO 13485 certification underscores its adherence to the highest global standards, ensuring superior performance and compliance.

Annually, BBI’s reagents play a pivotal role in 400 million lateral flow tests and are a trusted component in 5 billion blood glucose test strips -showcasing the company’s significant contribution to global health and solidifying its reputation as an industry leader.
With a focus on quality and customization, combined with a robust pipeline of recombinant products, BBI Solutions continues to meet the evolving demands of the market. Providing precise, cutting-edge solutions, guaranteeing its partners’ assays achieve market prominence and contribute to transformative patient outcomes.

Cardiff, 06 May 2024 – BBI Solutions OEM Limited (BBI), a trusted expert provider of end-to-end solutions for the development of high-performance assays, has signed a partnership agreement with BioAgilytix, a leading global bioanalytical laboratory. The partnership will integrate BBI’s ability to efficiently produce high-quality custom antibody reagents for a variety of testing applications, with BioAgilytix’s renowned bioanalytical testing services. This approach simplifies a crucial step in bioanalytical testing for pharma and biopharma sponsors. The more streamlined service will ultimately help bring customers one step closer to market for their innovative therapies.

As part of bioanalytical testing — a key aspect of bringing any new therapy to market — drug developers often need a variety of antibody reagents tailored to their candidate therapy, and for a range of testing applications. However, developing and securing a reliable supply of fit-for-purpose, customized antibody reagents is not easy. This step is often managed in isolation from other aspects of a bioanalytical testing program, which can further complicate the process.

The new partnership between BioAgilytix and BBI’s antibody development centre, MBS, will address this challenge. BBI’s proven, efficient mono- and polyclonal custom antibody reagent development services will be seamlessly integrated with BioAgilytix’s bioanalytical testing solutions. This simplifies the experience for bioanalytical testing customers, who can now work with a single provider for swift access to high-quality, custom antibody reagents suitable across testing applications.

“This partnership further strengthens an already excellent relationship with BioAgilytix through which BBI can utilize the depth of its antibody development expertise to provide custom solutions to its clients,” said Mathew Hobbs, Chief Commercial Officer, BBI.  “By streamlining a critical and complex step in bioanalytical testing, we’re helping customers get one step closer to delivering their innovative therapies to patients.”

“BioAgilytix prides itself in its scientist-to-scientist approach to assay development,” said Jim McNally, PhD., Chief Scientific Officer, BioAgilytix.  We work closely with our clients to design highly customized, high-quality bioanalytical assays in close partnership with their scientific teams.  This exciting partnership with BBI allows us to expand that relationship and accelerate the assay development process.  The scientific team at MBS has always delivered high-quality, high-science customer relationships which are essential to the assay development process.  Complex assay development has a clearer path forward with the quality antibodies MBS generates.”

To find out more about the combined service offering from BBI and BioAgilytix, please visit www.bioagilytix.com/about/partners. Alternatively, speak with experts from BBI and BioAgilytix at the 18th WRIB conference in San Antonio, Texas, USA, at booth #07 and 47, respectively.

ABOUT BBI

BBI is a leading global manufacturer of immunodiagnostic reagents and custom development solutions, with a history spanning over five decades in the in vitro diagnostics (IVD) industry. The company specializes in the development and manufacturing of high-quality raw materials for the IVD sector, including custom antibody development, recombinant proteins, a wide array of immunodiagnostic reagents, and support with lateral flow test development and manufacturing. Its operations are underpinned by ISO 13485-certified facilities located across four continents, ensuring compliance with industry standards and global reach.

BBI’s antibody development centre MBS, has over 30 years’ experience, and has developed thousands of custom antibodies in support of its pharmaceutical and IVD clients.  Paramount to every successful antibody development project is the team’s commitment to collaboration, communication, and excellence.

With a focus on quality, customization, and an extensive pipeline of recombinant products, BBI continues to address the evolving demands of the market by offering a range of precise, innovative solutions, guaranteeing that its partners’ assays achieve market prominence and contribute to transformative patient outcomes.

ABOUT BIOAGILYTIX

BioAgilytix is the trusted partner for bioanalytical services throughout every phase of the drug development process. As a leading global bioanalytical laboratory, the company provides established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC bioanalytical testing services in a GxP environment. BioAgilytix maintains state-of-the-art laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany.

For more information, please visit: www.bioagilytix.com

Cardiff, 8th April 2024 – BBI Solutions OEM Limited (BBI), the premier independent manufacturer of immunodiagnostic reagents globally, has announced the successful closing of the acquisition of IBEX Technologies Inc. (IBEX), a leading developer and manufacturer of high-precision enzymes and diagnostic solutions located in Montreal, Quebec. This acquisition strategically enhances BBI’s capabilities to support In Vitro Diagnostic (IVD) manufacturers with the growing global demand for IVD haemostasis testing, driven by an ageing population, the rising prevalence of chronic diseases, and an increased reliance on point-of-care tests in surgery and trauma settings. By incorporating IBEX’s innovative enzyme technologies into its extensive portfolio of recombinant proteins, BBI is also responding to the notable industry shift towards recombinantly produced reagents for IVD tests, reflecting a growing preference for more standardized and reliable testing methodologies.

The acquisition, effective 8th April 2024, further cements BBI’s position as the indispensable partner for IVD manufacturers worldwide, as Mario Gualano, Chief Executive Officer of BBI explains: “We are thrilled to welcome IBEX’s talented team to BBI and to incorporate their innovative enzymes into our rapidly expanding recombinant protein portfolio. It also marks a further milestone in our mission to be a crucial ally for IVD manufacturers worldwide by offering an extensive portfolio of critical raw materials, unparalleled expertise, and comprehensive support at every stage of assay development. BBI is entirely committed to ensuring the success of its partners’ assays and the resulting advancement of healthcare outcomes worldwide.”

Paul Behr, Chairman, President, and CEO of IBEX also commented on the acquisition: “Joining the BBI family marks the beginning of a promising new chapter for IBEX, with exciting development opportunities for us and our Canadian partners on the horizon. We are eager to see the innovative solutions this partnership will bring forth.”

BBI’s commitment to investing in the continuous growth and development of IBEX promises mutual benefits for customers and employees alike. All IBEX staff will transition to BBI, enjoying the benefits of being part of a renowned multinational organization, while customers can expect continued service excellence without interruption.

This partnership is set to offer significant strategic advantages, including a more diversified offering for IVD customers and a reinforced position in the diagnostic enzymes market. Supported by BBI’s strong distribution and manufacturing framework, it lays a robust foundation for further growth and enhanced service capabilities across the Globe.

In light of the successful closing of the transaction, IBEX has applied for delisting from the TSX Venture Exchange, which is expected to occur on or about Thursday, April 11, 2024.

ABOUT BBI

BBI is a leading global manufacturer of immunodiagnostic reagents and custom development solutions, with a history spanning over five decades in the in vitro diagnostics (IVD) industry. The company specializes in the development and manufacturing of high-quality raw materials for the IVD sector, including custom antibody development, recombinant proteins, a wide array of immunodiagnostic reagents, and support with lateral flow test development and manufacturing. Its operations are underpinned by ISO 13485-certified facilities located across four continents, ensuring compliance with industry standards and global reach.

Annually, BBI’s reagents play a pivotal role in 400 million lateral flow tests and are a trusted component in 5 billion blood glucose test strips, showcasing the company’s significant contribution to global health and solidifying its reputation as an industry leader.

With a focus on quality, customization, and an extensive pipeline of recombinant products, continues to address the evolving demands of the market by offering a range of precise, innovative solutions, guaranteeing that its partners’ assays achieve market prominence and contribute to transformative patient outcomes.

ABOUT IBEX

IBEX Pharmaceuticals Inc., a subsidiary of IBEX Technologies Inc., is a Montreal-based biotechnology company focused on the manufacturing and marketing of specialized enzymes for biomedical applications. The company’s expertise lies in the production and distribution of proprietary enzymes crucial for clinical diagnostics, including a suite of glycosaminoglycan (GAG) enzymes used extensively within the research community.

In addition to its proprietary products, IBEX Pharmaceuticals offers contract manufacturing services, providing custom reagent production for third-party diagnostics companies. The company is also involved in component filling for clinical diagnostic tests, ensuring quality and precision in the diagnostics supply chain.

IBEX Pharmaceuticals Inc. leverages its advanced manufacturing capabilities and extensive knowledge in enzymology to support the development and enhancement of biomedical diagnostics, contributing to the advancement of clinical research and healthcare outcomes.

BBI is excited to announce our participation in the upcoming Protein & Diagnostics Innovation Workshop 2025, hosted by Sartorius.

Taking place on July 2, 2025, at the Sartorius Korea Biotech Training Center in South Korea, the event will bring together leaders in the field of diagnostics and antibody development.

Our seminar will focus on the latest advancements in antibody optimization and bioproduction, featuring practical, real-world strategies to enhance your development pipeline.

Whether you’re advancing diagnostic platforms or refining antibody workflows, this workshop is an excellent opportunity to gain actionable insights and connect with industry peers.

🔗 Register Now for the Protein & Diagnostics Innovation Workshop 2025

📄 Download the Workshop Flyer (PDF)