Expanding its footprint in India, US-based molecular diagnostics company Cepheid Inc on July 12 announced its plans to establish a manufacturing unit in the country to improve Tuberculosis (TB) diagnostics.

Cepheid's GeneXpert MTB/RIF test is a closed-cartridge-based system that is easy to operate by minimally trained staff and gives results in approximately two hours, speeding the conventional backlog that used to exist in traditional diagnostic methods. The new manufacturing unit would produce MTB/RIF test cartridges, contribute to the government's "Make in India" initiative and thus bringing the company's global expertise in TB diagnostics to India, the company said in a statement.

As part of the plan, Cepheid also unveiled its latest portable, easy-to-use TB-testing system -- the GeneXpert Edge -- which is expected to be available in India later this year, the company said. The GeneXpert Edge is developed specifically for near-patient testing, to help support a one visit test-and-treat approach.

"Cepheid recognises the need for technological advancement and is committed to contributing significantly to India's goal of TB eradication," said Peter Farrell, Executive Vice President, Worldwide Commercial Operations, Cepheid. "We are hopeful that GeneXpert Edge will help eliminate delays in TB diagnostics by providing definitive results within hours and facilitating fast and easy last-mile delivery even in the remote villages of India," he added.

India has nearly one-fourth of the global TB patients and an estimated 4.8 lakh lives are lost every year due to delayed diagnosis and inadequate treatment and there are above 2.5 million new cases of TB every year. The country aims to eradicate TB by 2025. Approved by the World Health Organisation (WHO) in 2010, more than 1,200 Cepheid's GeneXpert Systems have been installed in the last two years at various Revised National Tuberculosis Control Programme (RNTCP) sites in the country and more than 2.5 million cartridges were supplied last year at various centres of Central TB Division (CTD).

Cepheid's Xpert MTB/RIF test has the potential to detect Mycobacterium tuberculosis (MTB) and rifampicin-resistance mutations, which are markers for MDR-TB strains in under two hours. Rifampicin is a drug commonly used in treating TB bacteria in first line of treatment. Xpert MTB/RIF tests also have excellent negative predictive value, which allows clinicians to manage TB-negative patients more effectively to prevent unnecessary and costly respiratory isolations.