EMPE Diagnostics unveils mfloDx MDR-TB test kit in Hyderabad
Clinicians can get confirmatory results in a qualitative ‘YES’ or ‘NO’ format, within three hours
EMPE Diagnostics launched its one-of-its-kind test kit — mfloDx MDR-TB — at the Telangana Lifesciences office, in Hyderabad. The path-breaking kit was unveiled by Kalvakuntla Taraka Rama Rao, Minister for IT, Industries and Municipal Administration, Government of Telangana and Raghavendra Goud Vaggu, Global CEO, EMPE Diagnostics, in the presence of Jayesh Ranjan, Principal Secretary, Industries and Commerce and Information Technology; Satish Reddy, Chairman - Dr Reddy Labs and Shakti Nagappan, Director, Lifesciences, Govt of Telangana, among other dignitaries.
The mfloDx MDR-TB is a rapid, accurate, and affordable kit that provides reliable answers about the bacterium and its resistance profile. The multiplex molecular test indicates the presence of Mycobacterium tuberculosis and its genotypic resistance profile by developing a visual signal. Clinicians can get confirmatory results in a qualitative ‘YES’ or ‘NO’ format, within three hours. The kit has been recognised by the World Health Organisation (WHO), approved by CDSCO in India and is currently undergoing clinical evaluation in multiple countries and has patents in 19 countries.
Rao said, “We have given impetus to the med-tech sector by strategically investing in world-class infrastructure. Now companies are proudly developing and manufacturing innovative medical products in Telangana — for Telangana and the world. I’m glad to have launched EMPE Diagnostics’s mfloDx️ MDR-TB test kit today — a first-of-its-kind in the world — that combines molecular and sensitive lateral flow biosensors, which can detect the presence of TB bacteria and identify antibiotic resistance accurately, in less than three hours even at resource-limited clinics. It is a matter of immense pride that it was developed and manufactured in our very own Genome Valley.”
According to Goud, the mfloDx MDR-TB test kit has been designed to detect tuberculosis (TB) and its antibiotic resistance. It includes controls and MDR-TB Rifampicin and Isoniazid and has been approved by Central Drugs Standard Control Organisation (CDSCO).
“We aim is to provide user-friendly diagnostic tests that deliver conclusive results for TB patients. In high tuberculosis burden countries, clinicians are often forced to start empirical antibiotic treatment without proper diagnosis, due to very limited or unavailability of user-friendly diagnostic tests that can provide confirmatory results. This often leads to suboptimal therapy with ineffective drugs, which not only fails to cure the patient but also allows the further spread of drug-resistant TB in society and increases the risk of the development of more resistant and refractory forms of TB. Therefore, WHO strongly recommends rapid molecular in first-line diagnostic monitoring for all suspected TB cases globally. At EMPE, we provide such diagnostic test kits for reducing the time required to initiate effective therapy for TB patients already at the initial contact between the patient and the health care facility,” said Goud.