US firm Cepheid to manufacture point-of-care COVID-19 diagnostic test kits in India

Representational image (Source: Reuters)

Representational image (Source: Reuters)

US-based molecular diagnostics company Cepheid said it is in the process of seeking approvals to manufacture point-of-care RT-PCR diagnostic catrithat will be made in India.

“From the manufacturing perspective of COVID (diagnostics), we are working on getting certain approvals, and then will be able to be part of Make-in-India,” Rashi Garg, General Manager of Cepheid said.

The company has set up manufacturing facility in Chennai in 2020, and plans to add another facility in Bengaluru. Currently it manufactures test cartridges for Tuberculosis (TB) testing which run on its GeneXpert System.

Cepheid received emergency authorisation from the USFDA in March 2020, for its COVID-19 test to detect coronavirus at the near point-of-care, delivering results in 45 minutes.

Cepheid developed the GeneXpert Xpress SARS-CoV-2 cartridge with $ 3.7 million in public funding from the US government’s Biomedical Advanced Research and Development Authority (BARDA). The GeneXpert testing platforms, which are already being used across the world for diagnosis of TB and other infectious diseases.

Along with SARS-CoV-2, the test can detect two types of Flu virus and RSV from a single patient sample, according to a company press release.

Point of Care tests are easy to use as they can be deployed in high-risk environments, such as homes, offices, and educational institutions, and require little or no specialist training.

There are an estimated 11,000 GeneXpert instruments in low- and middle-income countries, of which India alone has 1,200 Cepheid’s GeneXpert Systems installed in the last 2 years at various Revised National Tuberculosis Control Program (RNTCP) sites in the country and more than 2.5 million cartridges were supplied last year at various centres of Central TB Division (CTD).

Detecting drug resistant TB

The company launched GeneXpert Infinity and Omni systems for TB testing in India. The GeneXpert Infinity based on semi-automated real-time polymerase chain reaction (PCR) nucleic acid amplification technology, can simultaneously detect TB and Rifampicin (RIF) resistance in less than 2 hours.

The GeneXpert is a small machine, about the size of a microwave oven, that can fit easily on a small table.

In India Cepheid said it will be offering GeneXpert TB test at a “compassionate” price of $ 9.98.

“TB notification have dropped dramatically starting from March of last year, with the beginning of COVID, patients were not coming in for care, we have lost few steps in the battle against TB, hopefully coming out of this we will be in better place in managing TB,” said David H Persing, Executive Vice President, Chief Medical & Technology Officer, Cepheid.

Cepheid is an active participant in the global fight against TB, with support from partners to date including the Foundation for Innovative New Diagnostics (FIND), StopTB, USAID, UNITAID, the Bill and Melinda Gates Foundation and others.

“Over and above the scare of the ‘unknown’ with COVID last year, practical issues like new patients not reporting, less access to doctors, non-availability of drugs, no access to testing facilities, medication discontinuation etc all leading to predicted death from tuberculosis in 2020 to 1.66 million deaths,” said Dr Sonam Solanki, Consultant Pulmonologist, Masina Hospital.

“This number is what we had in 2015 and yes this a huge setback,” Solanki said.