Development and testing of a new POC for detecting drug resistance
mfloDx™ Technology: A novel multiplex platform for the detection of MDR-TB
Rapid detection of Mycobacterium tuberculosis complex (MTC) and its drug resistance are essential for the initiation of timely and correct drug therapy. This has become an even more urgent need due to the increased problems with TB and MDR-TB caused by the low tuberculosis controlling measures due to the SARS-CoV-2 pandemic, mass migration of people due to war, and unavailability of easy-to-use and rapid diagnostic methods. Enabling rapid and reliable diagnostic tests are crucial at the first clinical contact points to control TB infections and control the spread of antibiotic resistance in the community. Molecular diagnostic methods become handy in such scenarios due to their reliability and shorter turnaround times compared to phenotypic drug susceptibility testing. However, there is a huge gap between the need and the availability of molecular tests in the market.
EMPE Diagnostics has developed a multiplex molecular diagnostic platform called mfloDx™ by combining highly specific molecular techniques (padlock probe-dependent rolling circle amplification) with sensitive lateral flow biosensors (protein-thiolated oligo biochemistry). The molecular diagnostic tests based on mfloDx™ technology enable robust detection of MTC and its antibiotic resistance to the most important anti-TB drugs, directly from sputum samples, within 3 hours.
The mfloDx™ MDR-TB can detect MDR-TB by investigating resistance-related mutations in the rpoB, inhA and katG genes. This product has completed preliminary evaluations in Spain and India. Currently, we are conducting the first part of clinical evaluations, as per the Indian FDA guidelines, at the National Institute of Research in Tuberculosis (NIRT), the WHO Supranational Reference Laboratory, India. In addition, we will soon initiate multicentre clinical evaluations in Europe and India.