OpGen, FIND Sign R&D Collaboration for Rapid Detection of AMR via Blood Culture

OpGen announced Tuesday it has signed a research and development collaboration agreement with FIND, a global alliance focused on bringing diagnostics throughout the developing world, for a feasibility study on the use of Unyvero A30 RQ platform for use in rapid pathogen ID and antimicrobial resistance (AMR) testing from blood culture samples in low- and middle-income countries (LMICs).

During the feasibility study, scientists at OpGen’s German subsidiary Curetis will work to develop a molecular testing panel with a comprehensive set of pathogen ID and AMR detection assays while also creating a simple, easy-to-perform workflow for testing using the blood culture systems available in target regions without the need for sample preparation. The collaboration’s goal is to find methods to adapt the A30 RQ platform—which is capable of test for up to 33 diagnostic targets from a single specimen—for use in environments often found in LMICs, such as those with continuous operation with unstable power grids.

“AMR is one of the most pressing health emergencies of our time, with the potential to undo decades of medical progress,” said Cecilia Ferreyra, director of AMR at FIND. “Simplifying blood culture systems so that the pathogen responsible for an illness and its resistance profile can both be identified quickly is crucial for halting and preventing this silent pandemic, especially in LMICs that bear the greatest burden of AMR.”

Based on the results of the feasibility study, co-funded by FIND with €700,000, which is anticipated to be completed by the end of the first quarter of 2023, OpGen and FIND will discuss the option of future collaboration and a commercialization agreement. Such a collaboration would be focused on bringing the Unyvero A30 RQ platform and the first products developed in the feasibility collaboration through the necessary clinical studies for marketing approval. Further, the two partners aim to develop the products that can be sold at a price point that will encourage the use of the tests to help address the unmet testing need for AMRs in LMICs.

OpGen noted that the platform, which uses a one-time use disposable cartridge and can deliver results in 30 to 90 minutes depending on the complexity of the test being run, is a good candidate for use in LMICs for rapid AMR detection due to the low cost of good associated with producing the assays.

“We are excited to partner with FIND, in demonstrating that our Unyvero A30 RQ platform is ideally suited to being used in LMICs for rapid detection of AMR which is a truly global issue that must be addressed in a multilateral and indeed global fashion,” said Oliver Schacht, president & CEO of OpGen in a press release. “The R&D contract and associated funding will support the required R&D efforts on our side and expedite such development.”

FIND (Foundation for Innovative New Diagnostics), based in Geneva, Switzerland, was created in 2003 at the World Health Assembly to address the pressing need for affordable diagnostic tests in LMICs. It was launched by the Bill and Melinda Gates Foundation and World Health Organization’s Special Programme for Research and Training in Tropical Diseases (TDR). Its initial focus was to speed up the development and evaluation of tuberculosis tests. Since then, its work has expanded to include improving diagnosis in other diseases including hepatitis C, HIV, malaria, and neglected tropical diseases.

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PRESS RELEASE: BD MAX™ Molecular Multi-Drug Resistant Tuberculosis Test To Be Included In WHO Updated Consolidated Guidelines On Tuberculosis

BD, a leading global medical technology company, today announced that its BD MAX™ Molecular Multi-Drug Resistant Tuberculosis (MDR-TB) Assay was included in the moderate complexity automated NAAT class of molecular diagnostic technologies that were recognized for high diagnostic accuracy for tuberculosis testing by the World Health Organization (WHO) in advance of an update to its guidelines for TB diagnostic tests.

Laboratorians and clinicians can use the BD MAX™ MDR-TB Assay to simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain mutations associated with resistance to two important first-line drugs, isoniazid (INH) and rifampicin (RIF), enhancing the information available to direct the optimal treatment for their patients.

"BD is keenly focused on the fight against antimicrobial resistance and we believe the BD MAX™ MDR-TB Assay will make a real impact on the detection of MDR-TB and better inform which treatment regimen to use for TB patients," said Dave Hickey, president of Life Sciences for BD. "This recognition by WHO is a significant milestone for this product and furthers BD's commitment in the fight to end TB. We look forward to WHO releasing its updated guidelines later this year."

The BD MAX™ MDR-TB Assay is an in vitro diagnostic device with CE mark available in Europe and other countries around the world. The PCR-based molecular diagnostic test is an integrated diagnostic test intended to help in the detection and diagnosis of TB, and INH and RIF resistance in a single assay.

Every year, about 10 million people develop TB and 1.4 million die from the disease. Until the global COVID-19 pandemic, TB was the leading cause of death from a single infectious agent. With proper detection and treatment, TB is curable. Multidrug-resistant TB (MDR-TB), defined as resistance to both isoniazid and rifampicin, remains a critical hurdle in the fight to eradicate tuberculosis as patients with this type of TB will not benefit from those key medicines and could spread the resistant forms of the disease to others.1 Additionally standard testing that only detects RIF resistance can miss cases of TB infection resistant to INH further delaying appropriate treatment and cure for those in need.

BD has a long history in TB diagnostics, having launched the first automated liquid culture system, the BD BACTEC™ MGIT™ Automated Mycobacterial Detection System for comprehensive testing for TB, drug susceptibility and monitoring patients' response to treatment. The BD MAX™ MDR-TB Assay complements this technology enabling clinicians to rapidly test for TB and multidrug resistance as a first-line test and then use the BD BACTEC™ MGIT™ System for broader drug susceptibility testing and patient monitoring.

BD offers a free on-demand webinar featuring Dr. Daniela Maria Cirillo, president of the European Society of Mycobacteriology and head of the Emerging Bacterial Pathogen Research unit at San Raffaele Scientific Institute in Milan. The webinar explores the importance of laboratory diagnostics to stop TB, as well as how the STOP TB Partnership and the ongoing work of the European Society of Mycobacteriology are working to help fight TB. View the on-demand webinar at labroots.com (https://www.labroots.com/webinar/importance-laboratory-diagnostics-fight-tuberculosis).

About BD MAX™ SYSTEM

The BD MAX™ System is a molecular diagnostic platform already in use at thousands of laboratories worldwide. The system is fully automated, reducing the opportunity for human error and increasing the speed to result, and can process 24 samples simultaneously, and up to several hundred samples per 24-hour period. Each unit is capable of performing assays for respiratory infections, enterics, hospital acquired infections, and sexually transmitted infections.

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