India ramping up monkeypox testing capacity amid rising cases: Here's how

Tapping the TB testing network, screening tests, quick-result PCRs are all in the works

With India having nine laboratory-confirmed cases of monkeypox and experts cautioning that testing for this disease is low owing to social prejudices that go with it, the country is amping up its testing capacity.

This is in addition to leveraging the tuberculosis-testing network in the country.

Several other point-of-care testing kits are in the process of being made.

The recently formed “Central Task Force on Monkeypox” too has stressed developing diagnostics and vaccines for this contagious disease.

Globally almost 98 per cent of the monkeypox cases have been detected among gay or bisexual men though it is not classified as a sexually transmitted disease.

Point-of-care testing, screening and a wide network of testing in the hinterland are likely to help arrest the spread of the disease.

Goa-based molecular diagnostics company Molbio Diagnostics has developed a test kit using its Truenat platform.

Molbio founder, director, and Chief Executive Officer Sriram Natarajan said the test would be able to leverage the Truenat machines, which are already deployed.

“Truenat is the only point-of-care RT-PCR platform used by the World Health Organization to detect tuberculosis. The test is developed on the Truenat platform, and there are around 5,000 such machines deployed across India, including rural areas,” Natarajan said.

Start-ups like Gurugram-based Genes2Me, one of India’s leading in-vitro diagnostic (IVD) manufacturers, has come up with a real-time PCR (RT-PCR) kit for detecting monkeypox in 50 minutes.

“At present, it is a screening kit and not a diagnostic confirmatory. It has to be clinically tested with enough samples and we do not have as many positive samples,” said Neeraj Gupta, CEO and founder.

This kit is available in both the standard version for any commonly available RT-PCR instruments as well as point-of-care format on a Genes2Me rapid RT-PCR device. The company is targeting to use the point-of-care solution at key areas like airports, hospitals, diagnostic labs, and health camps.

As it is used for screening purposes only now, positive samples can be sent to the National Institute of Virology, Pune, for a confirmatory test. The company, which is working on the product tryout, is waiting for approval from the Indian Council of Medical Research (ICMR) for a clinical study and the Drug Controller General of India for manufacturing.

“Now we can manufacture 5 million test kits a week. It can be scaled up to 2 million a day,” Gupta said.

Chennai-based medical device maker Trivitron Healthcare has developed a Real-Time PCR-based kit for detecting the monkeypox (orthopoxvirus) virus.

Trivitron’s Real-Time PCR Kit is a four-colour fluorescence-based one that can differentiate between smallpox and monkeypox in a one-tube single reaction format, with a turnaround time of one hour.

“In this four-gene RT-PCR kit, the first target detects the viruses in the wider orthopox group, the second and third targets detect and differentiate the monkeypox and smallpox viruses, respectively, and the fourth one detects the internal control corresponding to human cells to address the assay performance and aid in following its epidemic spread,” the company said.

At present, 15 virus research and diagnostic labs (VRDLs), including the NIV -- all under the ICMR -- are equipped to test for monkeypox.

The Centre is planning to scale this up to 40, besides having 70 integrated disease surveillance programme labs under the National Centre for Disease Control.

Private labs are not far behind. A leading lab chain said it had started developing the test in-house in anticipation of demand from doctors.

“We will be ready if the government allows private testing,” the CEO of a lab chain told Business Standard. 

The global market for Real-time PCR (qPCR) and Digital PCR (dPCR) is expected to touch around $4.2 billion by 2027, growing at an annual growth rate of 7 per cent. 

Getting ready

• 5,000 Truenat machines deployed all over India 
• Molbio has developed monkeypox test on the Truenat platform
• Truenat is the only point of care test used by WHO to test for TB
• Genes2Me has developed a quick detection RT-PCR for monkeypox
• Genes2Me test can act as a screening test at airports, hospitals, etc
• Trivitron Healthcare has also developed a monkeypox RT-PCR test kit