“Early and consistent tuberculosis detection to break infection chains and eliminate the disease worldwide”
R-Biopharm has launched a new generation of diagnostics for the global fight against tuberculosis (TB). Their innovative approach represents a significant step forward compared to traditional Interferon-Gamma Release Assays (IGRA tests). A conversation with Dirk Dressler, Head of Business Development and TB Diagnostics at R-Biopharm, about the innovative approach, its development, and its potential.
The development of a new diagnostic tool takes time and money. What motivated R-Biopharm to invest in tuberculosis testing?
Our company’s goal is to enable health and quality of life for all people. Tuberculosis is one of the most common infectious diseases leading to death worldwide. It is among the top ten causes of death globally, with more than one million deaths per year. About a quarter of the world’s population is latently infected with TB. Tuberculosis can break out due to a weakened immune system, such as in cases of illness or required immunosuppressive therapy, with all the consequences for the patient and a potential risk of infection for contacts.
Early and consistent tuberculosis detection and treatment are important to break infection chains and eliminate the disease worldwide. This is also reminded by the international World Tuberculosis Day on March 24th each year.
What is special about R-Biopharm’s new tuberculosis diagnostics?
It takes a novel diagnostic approach using the innovative biomarker IP-10. Additionally, it offers two options for simple, efficient, and reliable confirmation of a tuberculosis infection with more efficient sampling and different platforms, RIDASCREEN® TB and RIDA®QUICK TB.
Why is the biomarker IP-10 so special?
In previous test forms, tuberculosis detection is done via the cytokine interferon-γ. It is released when T cells come into contact with specific tuberculosis antigens. Interferon-γ, in turn, stimulates a variety of immune cells to produce the chemokine IP-10. After this specific stimulation, IP-10 is present in concentrations up to 100 times higher than interferon-γ. This advantageous expression profile of IP-10 contributes to improved test sensitivity. Our product portfolio can significantly improve diagnostics, especially in difficult cohorts such as children, immunocompromised individuals, and HIV patients.
How did R-Biopharm come up with the idea of tuberculosis detection using IP-10?
Our experts are always looking for innovative approaches in diagnostics to provide the healthcare system with new and better tools. They became aware of the work of the Statens Serum Institute in Denmark and their basic research on IP-10 in connection with tuberculosis. Through close contacts with the Statens Serum Institute, R-Biopharm was able to obtain an exclusive license for the worldwide use of their IP-10 patent. The technical implementation of these scientific findings into reliably applicable test systems is, however, the achievement of R-Biopharm. The diagnostic test systems were developed in Germany, are produced at the headquarters in Darmstadt, and are now also approved under the new CE-IVDR.
What is the innovation in sampling and testing?
Our detection works with three instead of the previous four blood collection tubes – one for tuberculosis detection itself and one each for positive and negative control. We have developed the tubes from scratch so that blood can be drawn and incubated directly in them. They are sterile and already contain all the necessary reagents – the tubes for TB detection with the specific tuberculosis peptides ESAT-6 and CFP-10. Direct collection into the tubes for incubation requires less patient blood and significantly reduces the workload for medical staff.
After incubating the sample, the user can choose between two test processing systems. One is the RIDA®QUICK TB. This is a lateral flow test, known to the public since the corona pandemic. With one cassette per patient, it enables quick, flexible, and individual testing. Its processing, as well as the reading and interpretation of the results with the RIDA®Q3 Reader, are very simple. The result is available in just 15 minutes.
The second test processing method is the RIDASCREEN® TB. This is an ELISA test with up to 28 determinations per plate and all reagents. It can be processed manually or automatically.
We have over 30 years of experience with ELISA and lateral flow – both as developers and producers of our own tests, as well as in contract manufacturing for other companies.
For which applications are these solutions particularly suitable?
Both test systems are intended for use by professionals.
The ELISA test RIDASCREEN® TB is intended for central laboratories and laboratories with higher sample throughput.
The RIDA®QUICK TB does not require elaborate laboratory equipment and thus reduces transport and logistics efforts. It is suitable for laboratories with low sample volumes or for times with lower demand, such as weekends. Above all, it is suitable for decentralized testing, for example in remote areas. With the RIDA®QUICK TB, we provide countries with low laboratory infrastructure with an effective tool in the fight against tuberculosis.
The WHO has set the goal of eliminating tuberculosis worldwide. How can R-Biopharm contribute to this?
R-Biopharm is a company with over 30 years of history as a diagnostics manufacturer. We have proven ourselves as a reliable partner in the fight against SARS-CoV-2 during the pandemic. With our infrastructure, worldwide subsidiaries, and long-standing, trusted relationships with our distributors, we are able to make this innovation available worldwide.
The products of our tuberculosis portfolio have CE IVDR approval. Thus, we meet the latest European quality standards for in-vitro diagnostics. The new IVDR sets even higher standards for quality compared to the previous directive.
We are currently working on expanding the corresponding code of the uniform evaluation standard (EBM) to include tuberculosis detection via IP-10. This will allow the test to be included in the health insurance catalog and billed as a contractual medical service.
It is particularly important to us that our tuberculosis diagnostics have already been included in the procurement list of the Global Fund, a worldwide fund to combat AIDS, tuberculosis, and malaria. It finances the fight against these serious infectious diseases in more than 100 countries worldwide – especially those with low and middle incomes. And this is exactly what we at R-Biopharm want to contribute to with our tuberculosis diagnostics “Developed and Made in Germany.”