Each day 4,100 people die from tuberculosis, a preventable disease. The ‘Global Plan to End TB’ is a costed public health plan that aims to cut deaths by 90% in eight years. A key recommendation of the report is to universally replace sputum microscopy with a rapid molecular diagnostic, such as Actiphage®, developed by PBD Biotech. Mondana Cook has joined the company as the Chief Operating Officer to progress its Actiphage diagnosis to meet this global challenge.
Mondana explains: “TB is a devastating disease which has personally touched my family. I feel passionately about making a contribution to the early diagnosis, treatment and eradication of this disease, which impacts the lives of millions of people worldwide.”
Mondana previously held positions as Chief Operating Officer at the precision medicine and diagnostics company Kinomica, was Director of Program Management at QIAGEN and has been involved in the development of a tuberculosis vaccine.
She says she was attracted to PBD Biotech by its mission: “To support the eradication of tuberculosis and related mycobacterial diseases through early-stage detection of carriers.”
PBD Biotech’s Actiphage diagnostic can identify the presence of live mycobacteria in blood at an early stage of infection, providing for the first time a way to screen vulnerable populations for TB and related diseases, before they become infectious or show clinical signs of the disease.
Mondana’s role is to further develop the Actiphage diagnostic. “I see my role as continuing the transition into products and global healthcare solutions. This will involve collaborations to further enhance the product development and clinical data packages, scale up of product manufacture, and achieve successful regulatory submissions and registrations. This work will culminate in the full product launch of a human diagnostic for TB.”
PBD Biotech has pursued the development of phage-based diagnostics for both human and animal health. It has recently launched a service for testing cattle and milk for Johne’s Disease caused by paratuberculosis (MAP) and has gained CPI funding to develop its quality management system, which is essential for human diagnostics.
Mondana explains the significance of this: “The CPI funding enables PBD Biotech to fast-track the implementation of a quality management system to ISO 13485. This is the standard used to ensure the quality and safety of medical devices and will underpin the use of the diagnostics to support food security and animal health, as well as support the development program for a human TB diagnostic.”
PBD Biotech CEO Jane Theaker has worked previously with Mondana: “I am delighted to welcome Mondana on board, bringing her international experience and knowledge of human diagnostics from major players in the industry. She joins at an exciting time for the company as early results from human trials are very promising. We are grateful to Geoff Gower in his role as interim Operations Director. His input has been invaluable in setting up a commercial Johne’s Disease testing service, which is growing rapidly in the UK and attracting interest from overseas.”
Tuberculosis is second only to Covid as a fatal infectious disease and a ‘Global Plan to End TB’ highlighted the critical need for new diagnostics for TB.
Mondana continues: “The identification of Mycobacteria responsible for disease is fundamental to accurate diagnosis and management of the disease. However, prompt identification of infection is difficult, as the current gold-standard diagnosis is based on culture of bacteria, which takes over 20 days to produce a result. This diagnostic for TB also relies on testing sputum, however 40% of adults with TB and the majority of children struggle to generate sputum.
“Actiphage identifies the presence of live mycobacteria in a blood sample and can be used to detect very low levels of infection, often before the symptoms have developed and the disease becomes contagious. It can also have a predictive role in identifying subjects with the infection at risk of developing the disease.
“Estimates in the recent report suggest that with good diagnostics and a vaccine it would be possible to prevent 26.5million cases over eight years. I want to play my part in that success story – that is why I joined PBD Biotech.”