Source : INDIA TODAY NEWS
A key issue in the raging Ebola outbreak – a deadly disease with a frighteningly high fatality rate – in the Democratic Republic of Congo (DRC) has been a shortage of testing kits.
Now, an Indian medical diagnostics company, whose testing technology proved vital during India’s fight against the COVID-19 pandemic, is pitching in to fill the gap and support efforts to curb the deadly virus.
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Goa-based Molbio Diagnostics has developed a real-time PCR test capable of detecting the virus and is working with the World Health Organization (WHO), the Africa Centres for Disease Control and Prevention, and local authorities to urgently validate the test on clinical specimens.
Designed for decentralised settings, the test runs on Molbio’s near-patient portable Truenat platform and delivers results in approximately one hour, enabling faster clinical decision-making and timely public health intervention, the company told India Today.
The ongoing outbreak, driven by the comparatively less-understood Bundibugyo strain of Ebola, was confirmed last month and has claimed at least 62 lives. So far, 363 cases have been confirmed in the DRC in Central Africa.
In neighbouring Uganda, one death due to the highly contagious disease has been confirmed so far, while 15 other people have tested positive. The true toll of the epidemic, however, is believed to be far higher.
In a press briefing on June 4, World Health Organisation (WHO) Director-General Tedros Adhanom Ghebreyesus described testing as the biggest challenge.
“One of our key priorities is to scale up laboratory and diagnostic capacity, to reduce delays in case confirmation and support faster response decisions,” the WHO chief exhorted.
HOW EBOLA IS TESTED
Ebola, much like COVID-19 and influenza, is diagnosed using RT-PCR technology, which remains the global gold standard for detecting viral infections.
RT-PCR functions by identifying and amplifying specific genetic markers of a virus to accurately determine the presence or absence of infection. While the technology itself has been available for several decades, its adoption has historically been limited by the need for highly specialised laboratory infrastructure, significant capital investment, and trained technical personnel.
As a result, conventional RT-PCR testing has largely remained centralised, confined to advanced laboratories capable of handling complex workflows and high operational demands.
This often creates challenges during outbreaks, particularly in remote or resource-constrained regions where rapid diagnosis is most critical.
Talking to India Today, Shiva Sriram, president of Molbio Diagnostics, said that Truenat is currently the only point-of-care PCR platform globally that enables multi-disease testing on a single portable system.
Truenat, first developed to detect tuberculosis – a leading public health challenge in India – was designed to address these limitations through a decentralised and accessible approach to molecular diagnostics.
“The platform is portable, scalable, and specifically designed for deployment across primary healthcare centres, district hospitals, and remote or resource-constrained settings,” he said.
A key advantage of the platform is its multi-disease capability.
The same Truenat system can be used to test for a range of infectious diseases, including tuberculosis, COVID-19, HPV, dengue, and potentially Ebola, enabling healthcare systems to maximise existing diagnostic infrastructure while improving access to timely testing, Sriram added.
During the pandemic, many developed nations continued to rely heavily on centralised testing models, where samples needed to be transported to large reference laboratories, often leading to delays in diagnosis and reporting.
India, however, benefited from an already established and distributed Truenat network across the country, he added.
This enabled the rapid deployment of thousands of Truenat systems across districts, blocks, and remote geographies, significantly expanding access to molecular testing during a period of unprecedented demand.
As of now, India has more than 13,000 Truenat machines installed nationwide, creating one of the world’s largest decentralised molecular diagnostic networks.
STEPPING UP FOR EBOLA
At present, the Ebola assay is undergoing clinical validation in the DRC and Uganda, where the technology is being assessed for its effectiveness in outbreak-response settings.
In India, the company has formally approached the Indian Council of Medical Research (ICMR) for local clinical validation, a critical prerequisite for obtaining regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for manufacturing and deployment.
Once the necessary regulatory approvals are secured, the Ebola assay can be rapidly integrated into the existing Truenat network already deployed across India and several African countries, enabling faster and more decentralised access to molecular testing during outbreak situations, the Molbio president said.
After the WHO recently opened applications for Emergency Use Listing (EUL) for Ebola PCR tests, the company initiated the application process accordingly.
However, regulatory pathways remain closely interconnected.
In order to complete the WHO emergency-use documentation and progress towards broader deployment, the necessary regulatory approvals from the CDSCO in India will also be required, Sriram explained.
– Ends
SOURCE :- TIMES OF INDIA
