EMPE Diagnostics


In high Tuberculosis (TB) 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. EMPE provides such diagnostic test kits to significantly reduce the time required to initiate effective therapy for TB patients already at the initial contact between the patient and the health care facility.

Sample to result in 3 hours!
Customizable and suitable for resource-limited clinical laboratories

EMPE’s diagnostic platform is inexpensive, easy to use and provides reliable answers about the bacterium and its resistance profile. Our 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 3 hours. As a result, doctors will be able to select the appropriate drugs enabling effective antibiotic treatment and limiting the transmission of Drug Resistance e.g. our first product mfloDx™ MDR-TB.

mfloDx™ MDR-TB Kit

The COVID-19 pandemic has reversed years of progress in providing essential TB services and reducing the TB disease burden.

Notwithstanding, some country and regional success stories, the global TB targets are largely off-track. The most obvious impact is a large global drop in the number of people newly diagnosed with TB and reported. This fell from 7.1 million in 2019 to 5.8 million in 2020, an 18% decline back to the level of 2012 and far short of the approximately 10 million people who developed TB in 2020. 16 countries accounted for 93% of this reduction, with India, Indonesia, and the Philippines, the worst affected. Provisional data up to June 2021 show ongoing shortfalls.

Reduced access to TB diagnosis and treatment has resulted in an increase in TB deaths. The best estimates for 2020 are 1.3 million TB deaths among HIV-negative people (up from 1.2 million in 2019) and an additional 214,000 among HIV-positive people (up from 209,000 in 2019), with the combined total back to the level of 2017. Declines in TB incidence (the number of people developing TB each year) achieved in previous years have slowed almost to a halt. These impacts are forecast to be much worse in 2021 and 2022.

Other impacts include reductions in between 2019 and 2020 in the number of people provided with treatment for drugresistant TB (-15%, from 177 100 to 150,359, about 1 in 3 of those in need) and TB preventive treatment (-21%, from 3.6 million to 2.8 million), and a fall in global spending on TB diagnostic, treatment and prevention services (from US$ 5.8 billion to US$ 5.3 billion, less than half of what is needed).

Actions to mitigate and reverse these impacts are urgently required. The immediate priority is to restore access to and provision of essential TB services such that levels of TB case detection and treatment can recover to at least 2019 levels, especially in the most badly-affected countries.

Source: Box 1 from “Global tuberculosis report 2021. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.”

Global trends in the estimated number of incident TB cases (left) and the incidence rate (right), 2015-2020 (Shaded areas represent uncertainty intervals. The horizontal dashed line shows the 2020 milestone of the End TB Strategy)

The eight countries that rank first to eighth in terms of numbers of cases, and that accounted for two thirds of global cases in 2020, are labelled.

Source: GLOBAL TUBERCULOSIS REPORT 2021, © World Health Organization 2021; licence CC BY-NC-SA 3.0 IGO