Serum Institute of India, Mylab launch TB kit for latent infections

The partnership between SII and Mylab is focusing on creating a comprehensive ecosystem for TB diagnosis, treatment, and prevention through various interventions

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A point-of-care skin test for detecting latent tuberculosis infections (LTBI) -- developed by Serum Institute of India (SII) and Mylab Discovery Solutions -- was launched on Monday at a cost the companies claimed to be 50-70 per cent lower than comparable tests available now.

The SII-Mylab partnership is working on the ecosystem of tuberculosis diagnosis, treatment, and prevention through several interventions.

As India targets eliminating tuberculosis by 2025, testing for latent tuberculosis becomes critical before it turns active. 

The World Health Organization has estimated that one-fourth of the global population is infected with mycobacterium tuberculosis and 5-10 per cent of those who are infected will develop active tuberculosis.

India has 27 per cent of global tuberculosis patients. It is estimated that 350-500 million in India have tuberculosis infections and over 2.6 million people develop the disease annually. Additionally, the prevalence rate of latent tuberculosis is there in 30-40 per cent of the population. Various studies indicate that a higher prevalence of LTBI would contribute to a higher incidence and mortality of the disease.

Hasmukh Rawal, managing director and co-founder of Mylab, told Business Standard the test would cost Rs 1,200-1,500. The National Tuberculosis Elimination Programme has included the Cy-TB test on the Ni-kshay platform. This marks a leap forward in the country’s tuberculosis control.

SII-Mylab will supply both to the government (at cheaper rates) and the market.

Rawal said they had begun talks with diagnostic companies and hospital chains for this test, and that no other company could develop and launch this in the market for another three-four years because it required a significant amount of clinical validation.

Umesh Shaligram, executive director, research and development, SII, told Business Standard the test was developed after “significant investment” over more than 10 years. He said the interferon gamma release assay (IGRA), a laboratory test, was accurate but costly (at Rs 3,000-6,000). On the other hand, there are protein-purified derivative tests, which are point-of-care skin tests but may give false positives for a person who has been vaccinated with BCG.

Shaligram said Cy-TB combined the cost-effectiveness and simplicity of skin tests with the accuracy of traditional IGRA.

“The medical staff is exposed to tuberculosis, and they need to take this test. Private hospitals can use this test for their staff and patients who are undergoing cancer treatment or are otherwise immuno-compromised. The government is keen to test close contacts of tuberculosis patients,” he said.